To assess the efficacy of MASO65D (Xclair™) in managing radiation dermatitis (RD) during radiation therapy and the follow-up period

Patients were randomized to use of MASO65D or the control cream. The control vehicle was an emollient-based cream that was similar in color and consistency but did not contain key ingredients. Patients had to observe a washout period of seven days. Patients were also instructed to apply study cream on the irradiated area three times daily, starting on first day of irradiation and continuing until three weeks after completion of radiation therapy. Patients were examined at weekly intervals during radiation therapy and three weeks after its completion.

• The study sample was comprised of female, Caucasian patients with breast cancer.
• Mean age was 57.26 years, with a range of 33.1 to 76.9 years.
• All patients scored 100% on the Karnofsky Scale.

The study took place at the European Institute of Oncology in Milan, Italy.

The study used a randomized double-blind vehicle-controlled design.

• Skin toxicity was graded using the National Cancer Institute Common Termonology Criteria for Adverse Events for erythema, desquamation, edema, moist desquamation and ulceration.
• Differences between arms of study were analyzed using the Mann-Whitney Test.
• Itch, pain, and burning were assessed using a 0–10 cm visual analogue scale, with zero being \"none\" and 10 being \"worst severity possible.
• The Karnofsky performance score, tobacco use, breast size, breast condition, and skin pigment were recorded at baseline.

The study demonstrated a statistically significant difference between vehicle and MAS065D groups regarding the maximum severity of skin toxicity (p < 0.0001), symptoms of burning within the radiation field (p = 0.039), and desquamation (p = 0.02). In the MAS065D group, 13.5% reported mild-to-moderate desquamation, compared with 50% in the vehicle group. A higher proportion of the experimental group had no desquamation. The most significant differences between the two groups were recorded after three weeks of treatment. Both study creams were well tolerated for their cosmetic acceptability. No adverse events were observed or reported in either group of patients who completed the study.

MAS065D had a significantly better outcome with prevention and treatment of skin reactions.

• The study sample size was small.
• A higher proportion of women with fair skin was allocated to the vehicle group, which has the potential to confounded findings.
• Although five patients were withdrawn from the study, results are stated for 40 patients. It is not clear if the five cases withdrawn were eliminated from the statistical analysis.
• Researchers state that results for severity of symptoms, measured with the visal analogue scale, were analyzed with Chi-square analysis or Mann-Whitney, which are not the most appropriate for integer scale data.

The intervention consisted of relaxation and guided imagery provided to patients during hospitalization. The intervention group received training in relaxation and guided imagery for 10 minutes and was given an individualized cassette for use at home and at the hospital. The recording on the cassette consisted of instructions on head-to-toe relaxation and breathing techniques. Patients were then given descriptions of pleasing images (mountains, beach, etc.) based on information gathered from the patients prior to recording of the cassette. Patients in both groups received training regarding brachytherapy, but only study group patients received training in relaxation and guided imagery.

• The study reported on a sample of 66 patients: 32 in the intervention group and 34 in the control group.
• Patients had gynecologic and breast cancers and were undergoing brachytherapy during hospitalization.

Two hospitals in Spain

A randomized controlled trial design was used.

• Hospital Anxiety and Depression Scale (HADS)
• Cuestionario de Calidad de Vida (Spanish quality-of-life questionnaire that has been validated in a Spanish population).
• Pain Visual Analog Scale
• Measures were administered prior to, during, and after brachytherapy.

The intervention group demonstrated a statistically significant reduction in anxiety (p = 0.008) compared with the control group.

• Special training or costs included creation of the training program, cassettes, and guided imagery education.
• The small sample size limits generalizability.

To evaluate the efficacy and tolerability of sublingual fentanyl for the treatment of breakthrough pain in opioid-tolerant cancer patients

This study was conducted from July 2002 to January 2004 at five university clinics in Sweden. Patients had locally advanced or metastatic cancer and were currently

• Receiving scheduled opioids equivalent to 30–1000 mg/day of oral morphine or 25–300 mcg of transdermal fentanyl
• Experiencing at least four episodes of acute breakthrough pain over a 14-day period

Each patient received, at four pain episodes occurring between 0700 and 1600 (defined as the treatment period), a placebo dose and 100, 200, and 400 mcg doses of sublingual fentanyl. The doses were provided in a random order, according to a computer-generated randomization list. At least one day fell between each treatment period, to avoid carry-over effects. Patients were asked to rate their pain at the onset of an episode of breakthrough pain and then at 5, 10, 15, 20, and 30 minutes postingestion of the study drug. At 60 minutes, the patients were asked to make a global assessment of the treatment by using a four-point scale.

• Twenty-three patients completed the study.
• The sample was composed of male and female patients 18–90 years old.
• Ten of the 23 patients were female. Mean patient age of females was 63 years, and the age range of females was 46–80 years. Thirteen patients were male. Mean patient age of males was 65 years, and the age range of males was 40–74 years.
• Patients had locally advanced or metastatic cancer, and all 23 patients were opioid tolerant and Caucasian.

• Multisite
• Outpatient
• Five university clinics in Sweden

Randomized, multicenter double-blind, four-period crossover study

• Ungraded 100 mm visual analog scale (VAS), with 0 = no pain, 100 = worst conceivable pain
• Four-point scale (none, mild, moderate, excellent)

Twenty-three patients completed all four treatment doses. Twenty-two of the 23 patients (95%) reported that at least one dose of the sublingual fentanyl produced a clinically important decrease in pain intensity, as measured by a decrease in pain intensity of more than 20 mm on the VAS. In regard to adverse events, 13 patients reported 15 adverse events considered to be related to the study drug. The most common treatment-related adverse effects were nausea and dizziness. Increasing the doses of sublingual fenanyl did not appear to increase the number or severity of adverse events, when evaluated related to increasing doses of sublingual fentanyl.

Within 15 minutes of administration, 400 micrograms of sublingual fentanyl proved more effective than placebo at significantly improving overall pain intensity difference. This was true over the entire treatment period. In regard to reducing pain intensity, results showed that the 100 and 200 mcg doses of sublingual fentanyl were more effective than placebo.

• The study had a small sample size, with fewer than 30 patients.
• Authors did not specify whether the patients were concurrently receiving treatment for cancer.
• Authors did not provide an analysis of a dose-response relationship.
• The study did not evaluate statistical differences between the dose strengths used.

Further study is needed to determine, in regard to decreasing breakthrough pain, the efficacy of each of the doses of sublingual fentanyl.

To investigate the effects of mindfulness-based stress reduction (MBSR) on sleep parameters in women with breast cancer

Patients were randomized to the MBSR group or a usual care wait-list control group. MBSR was delivered in two-hour weekly sessions six times, including educational materials related to relaxation, meditation, healthy lifestyle, practice of meditation, yoga, body scan and walking meditation, and supportive group interaction and discussion. Patients were asked to practice meditative techniques 15–45 minutes daily. Study measures were obtained at baseline, six weeks, and 12 weeks.

• N = 79–77 (completed 12 weeks)
• MEAN AGE = 57 years (SD = 9.7 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All patients were diagnosed with breast cancer and had completed initial treatment within two weeks to two years previously. All had surgery. About half had stage 3 or 4 disease.
• OTHER KEY SAMPLE CHARACTERISTICS: 73% Caucasian; 59,5% married; 80% had at least some college or vocational education; 40% had an income of $40,000 or more; 30% were employed more than 32 hours per week

• SITE: Multi-site
• SETTING TYPE: Outpatient  
• LOCATION: Florida, United States

• PHASE OF CARE: Transition phase after active treatment

Randomized, controlled trial

• ActiGraph
• Pittsburgh Sleep Quality Index (PSQI)
• Sleep diary for 72 hours after each study assessment

From baseline to six weeks, there were no differences between the groups. From 6–12 weeks, there were improvements in the MBSR group in sleep efficiency and the number of times patients awoke as measured by actigraphy (between groups Cohen’s d = 0.33 – 0.38; p = 0.04; p < 0.01). There were no differences between groups in PSQI or sleep diary findings. Sleep efficiency, the percent of time per night in sleep, was 78.2% in the MBSR group compared to 74.6% in the control group. All sleep parameters improved in both groups. There was no correlation between how much individuals practiced and sleep outcomes.

The use of MBSR resulted in improvements in some sleep parameters.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Other limitations/explanation: No information was provided as to whether any patients were receiving other sleep-related interventions or medications. Compliance with actigraphy, home practice, and diary use was not clear. A 4% difference in sleep time was statistically significant and had a moderate effect size, but one might question if this is clinically relevant as well. It is not clear whether the six weekly sessions were given in the first six weeks or conducted every other week over the entire course of the study. Baseline sleep efficiency scores were 80%, suggesting there may be a ceiling effect in measure as well as a testing effect with repeated use of the PSQI.

The findings of this study suggest that MBSR as provided in this intervention might improve some sleep parameters compared to usual care control patients; however, sleep parameters did improve over time in all participants. This is a low-risk type of intervention, but it involves multiple sessions delivered in person. It is not known whether different delivery methods can be successful, what the appropriate and necessary timing should be, or what the frequency and duration of the delivered interventions should be.

To compare the prevalence and severity of symptoms and symptom clusters in patients with breast cancer who participated in a mindfulness-based stress reduction (MBSR) program to the symptoms and symptom clusters in patients who received usual care.

Women who expressed interest in participating in the study were randomly assigned to MBSR or usual care. The MBSR program lasted six weeks and included educational material, meditation practice in weekly group settings and homework, group discussion on barriers to meditation, application of mindfulness in daily life, and group support interactions. Meditation training consisted of sitting and walking meditation, body scan, and gentle Hatha yoga. Researchers obtained study measures at baseline and within two weeks of program conclusion. Hierarchical-cluster analysis was used to identify symptom clusters. Researchers compared each group's symptom clusters and individual symptoms to those of the other group.

• In total, 84 participants (100% female) were included.
• Mean patient age was 58 years (standard deviation = 9.4 years).
• Median time since diagnosis of breast cancer was 11 to 15 weeks.
   

• Single site
• Outpatient
• Florida

This was a randomized, controlled trial.

MD Anderson Symptom Inventory

Severity of symptoms declined in both groups from baseline to the end of the study. Fatigue and drowsiness declined more in the MBSR group (p = 0.05). Interference scores for mood and relationships also declined more in the MBSR group (p ≤ 0.05). Analysis of changes in symptom clusters showed no differences between groups. Clusters identified were gastrointestinal (nausea, vomiting, anorexia, shortness of breath, dry mouth, numbness), cognitive or psychological (distress, sadness, pain, remembering), and fatigue (fatigue, disturbed sleep, drowsiness). Cluster scores declined in both groups.

Findings suggested that MBSR interventions may benefit women with breast cancer who are managing fatigue or mood.

• The study had a small sample size, with less than 100 participants.    
• Baseline sample/group differences were of import.
• The study had risks of bias due to no blinding and no appropriate attentional control condition.
• The control group included significantly more black patients than did the MBSR group. Ethnic and cultural differences could impact the findings.
• The study did not state whether any patients were receiving antitumor treatment or if any patients had undergone surgery.
• The gastrointestinal cluster did not make clinical sense as a cluster. 
• Enrollment occurred by means of patient self-selection.
• Symptom severity scores at baseline were low in all patients (less than 4 on a 10-point scale).

Findings suggested that MBSR may be helpful, to some patients with breast cancer, as a means of combating fatigue and mood changes. Study limitations limited the strength of these findings.

To determine whether, compared to usual care, a mindfulness-based stress-reduction (MBSR) intervention involving breast cancer (BC) survivors is efficacious in improving psychological and physical status

Patients were randomized into one of two arms: the group receiving MBSR for BC patients (MBSR (BC)) and the group receiving usual care. Assignment to group was random and stratified by stage of cancer and treatment received; if desired, members of the usual-care group were wait-listed to receive the MBSR (BC) intervention. Assessments were completed at an initial baseline orientation and within two weeks of the end of the six-week intervention or control period. Data collectors were blinded to treatment assignment. The MBSR (BC) group received six weekly two-hour sessions led by a single trained psychologist. Class size was 4–8. Subjects received a training manual and four audiotapes to support home meditation practices. Members of the MBSR (BC) group kept a daily diary. Participants completed various activities during the six-week period. The intervention comprised three specific components:

• Educational material related to relaxation, meditation, and the mind-body connection
• Practice of meditation in group meetings and homework assignments
• Discussion, among group members, related to barriers to practicing meditation, application of mindfulness in daily situations, and use of a support group.

• Sample size was 82. Participants were enrolled during the 18-month post-treatment survivorship period.
• Mean patient age was 57.5 years (SD = 9.4 years).
• Of the participants:
  • 100% were female.
  • 70% had been diagnosed with cancer at stage 0 or I; 30%, at stage II or III; and 39% had received chemotherapy in combination with radiation therapy.
  • 30% had hypertension; 10%, diabetes mellitus.
  • 25% were taking antidepressants.

• Single site
• Outpatient
• H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida

Transition phase

Randomized controlled trial

• Concerns About Recurrence Scale
• State-Trait Anxiety Inventory
• Center for Epidemiological Studies Depression Scale
• Life Orientation Test, six items assessing positive or negative life-outcome expectations
• Perceived Stress Scale-10 item
• Medical Outcomes Study (MOS) SF-36, measuring quality of life
• MOS Social Support Survey, a 19-item measure of social support
• Two Likert-scaled items widely used in epidemiologic research to measure spirituality
• MD Anderson Symptoms Inventory, which measured self-reported symptoms

• Compared to participants receiving usual care, at six weeks participants receiving MBSR (BC) had significantly lower adjusted mean levels of
  • depression (6.3 versus 9.6, p = 0.03).
  • anxiety (28.3 versus 33.0, p = 0.03).
  • trait anxiety (30.4 versus 34.5, p = 0.004).
  • fear of recurrence (9.3 versus 11.6, p = 0.007).
  • recurrence concerns (26.7 versus 36.5, p = 0.01).
• Compared to participants receiving usual care, at six weeks participants receiving MBSR (BC) had higher
  • energy (53.5 versus 49.2, p = 0.02).
  • physical functioning (50.1 versus 47, p = 0.01).
  • physical role function (49.1 versus 42.8, p = 0.03).
• In stratified analyses, subjects more compliant with MBSR tended to experience greater improvements in measures of energy and physical functioning.
• Adjusted mean scores at six weeks—for social support, perceived stress, optimism, and spirituality—did not differ by treatment assignment.

Compared to usual care, the six-week MBSR (BC) program for BC survivors, within 18 months of treatment, resulted in significant improvements in psychological status and quality of life.

• The study had a small sample size, with fewer than 100 participants; therefore, the study was underpowered. Are outcomes sustainable?
• The study did not include long-term follow-up—especially important in this case because fear and anxiety can increase as patients get further from the treatment period.
• The study did not include an attention-only or support group as a control group.
• Only 70% of MBSR subjects were considered intervention-compliant.
• Many outcomes were self-reported using validated measures. Replicating this type of program may not be feasible. The ability to generalize study results is limited.

The symptoms this study addressed continue to be of great concern to patients with cancer. Nurses must know how to help patients with these symptoms during and after treatment. Nurses should explore alternative ways to educate patients about interventions that can improve outcomes.

To determine if a mindfulness-based stress reduction (MBSR) intervention is effective in improving psychological and physical status in breast cancer survivors

The intervention was six group sessions of an MBSR program using meditation and body scan techniques. Participants received a training manual and audiotapes to support home practice of various forms of meditation and gentle yoga. The training manual included weekly objectives, exercises, program content, and a daily diary for recording practice activities.

• The study reported on a sample of 82 female patients with breast cancer.
• In terms of age, 40% were younger than 55 years, and 27.4% were older than 65 years; the MBSR group had a significantly larger percentage of younger patients.
• All patients had undergone surgery and received either adjuvant radiation or chemotherapy. Therapy was completed within the prior 18 months.
• Of the sample, 56% were employed; 72.6% were white, non-Hispanic; 78.5% had at least some college level education; and 25% were on medications for depression.

• Single site
• Outpatient setting
• Florida

• Patients were undergoing the transition phase of care after initial treatment.
• The study has clinical applicability for late effects and survivorship.

A randomized controlled trial design was used.

• Concerns About Recurrence Scale – 30 items
• State-Trait Anxiety Inventory – 20 items
• Center for Epidemiologic Studies Depression Scale (CESDS) – 20 items
• Perceived Stress Scale – 10 items assessing how often in the past month life situations were stressful
• Life Orientation Test – 6 items to assess expectancy for positive and negative life outcomes
• Medical Outcomes Study Short Form General Health Survey
• Medical Outcomes Social Support Survey – 19 items

Seventy percent of participants were determined to be compliant with the program. Intervention participants had better mean scores for state anxiety and depression compared to the control group at six weeks (p = 0.004; p = 0.03).

The MBSR program improved psychological distress, fear of recurrence, and quality of life among patients with breast cancer who recently transitioned from active treatment. The extent of practice of MBSR activities appears to influence the overall degree of benefit derived. A large percentage of patients were able to comply with a complex MBSR intervention.

• The study had a limited follow-up period.
• The study design lacked an attentional control.

Whether benefits seen were due to the actual intervention or the supportive aspects of the group was unable to be determined. More than half of eligible patients approached for enrollment declined due to scheduling issues, travel distance, lack of interest, and other issues. This suggests that such a program is limited in application related to these types of issues.

To investigate the mechanisms of action of elements of mindfulness-based stress reduction (MBSR) that lead to specific clinical improvements, specifically to postulate and examine how changes in fear of recurrence as a result of participation in MBSR program may mediate a range of positive changes in psychological and physical symptoms and quality of life

At orientation, subjects were consented and randomized, and they completed baseline assessments. The assessments were completed again at two and six weeks following the MBSR program or control period. The program was adapted from the 1990 Jon Kabat-Zinn program. Subjects who were randomized to the MBSR group (n = 40) attended six, weekly, two-hour MBSR sessions with a trained psychologist. Participants learned four meditative practices, sitting meditation, walking meditation, body scan, and yoga, while integrating mindful attention to self-regulate and manage stressful symptoms. Participant materials included a training manual and audio tapes for home practice. Subjects completed a diary daily. Home meditation was advised for 15–45 minutes daily. The usual care (UC) group was offered the MBSR program after the six-week study period.

• N = 82  
• MEAN AGE = 57.2 years (SD = 9.2 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All diagnosed with primary stage 0, I, II, or III breast cancer; completed treatment within the prior 18 months
• OTHER KEY SAMPLE CHARACTERISTICS: Able to read and speak English at an eighth grade level

• SITE: Single-site    
• SETTING TYPE: Outpatient    
• LOCATION: H. Lee Moffitt Cancer Center, Tampa, FL

• PHASE OF CARE: Transition phase after active treatment
• APPLICATIONS: Elder care  

This was a randomized, controlled trial. Subjects were randomly assigned in a one-to-one ratio to either the MBSR or UC group. Randomization was stratified in an unblocked manner. Study personnel were blinded initially.

• To assess fear of recurrence as a potential mediator of the effects of MBSR, an analysis was conducted using six outcome measures in which MBSR demonstrated evidence of efficacy. These were perceived stress, depressive symptoms, state anxiety, trait anxiety, and aggregate mental and physical health.
• A 30-item Concerns about Recurrence Scale (CRS) was used.
• State and trait anxiety was measured by State-Trait Anxiety Inventory (STAI)
• Depression was measured by the Center for Epidemiological Studies Depression Scale (CES-D)
• Optimism was measure by the Life Orientation Test-Revised (LOT-R).
• Perceived stress was measure by the Perceived Stress Scale (PSS)
• Quality of life was measured by the Medical Outcomes Studies Short-Form General Health Survey (MOS SF-36) 
• Social Support was measured by the Medical Outcomes Study (MOS) Social Support Survey

From baseline to six-weeks, the MBSR group experience more favorable changes than the UC group for several potential mediators including fear of recurrence concerns (2.8 versus .2, p = .007); fear of recurrence problems (11.4 versus .2, p = .02); depression (7.2 versus 4, p = .04); physical functioning (3.8 versus .5, p = .01) and energy (8.8 versus 5, p = .07). After removing direct effects of MBSR on outcomes of interest, the strongest and most consistent evidence for mediating effects (how MBSR works) was for change in fear of recurrence problems and change in physical functioning. The results indicate that MBSR is associated with reduced fear of recurrence and improved physical functioning which in turn are associated with reduced perceived stress and state and trait anxiety. The women in the UC group who experienced reduced fear of recurrence and improved physical functioning by mechanisms other than MBSR also experienced significantly reduced perceived stress and anxiety. Both groups experienced reduced anxiety and depression over time. There were no significant differences in anxiety between groups. Postintervention, the MBSR group had significantly higher depression scores (p = .04).

The fear of recurrence is highly prevalent in breast cancer survivors and is associated with considerable psychological distress. The results of this study may indicate that one of the mechanisms for how MBSR (BC) works is through the cognitive process of self-regulation of fear of recurrence to improve stress, anxiety, and physical functioning. The fear of recurrence influence by MBSR (BC) appeared to be reliable and clinically relevant. The findings did not demonstrate a direct effect on anxiety or depression scores.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (sample characteristics)
• Findings not generalizable
• Intervention expensive, impractical, or training needs
• Other limitations/explanation: Trained psychologist and expensive intervention; included only early-stage breast cancer survivors; limited to short-term effects; symptoms at baseline were low for both groups, indicating a potential floor effect with little room for improvement

The findings of this study show a clustering of multiple symptoms among breast cancer survivors. Interventions to simultaneously address multiple symptoms should be studied. MBSR is supported as being beneficial in reducing fear of recurrence and improving physical functioning. Training programs and awareness for nurses and staff members should be supported in cancer centers and survivorship programs.

To compare the incidence of oral mucositis (OM) in patients conditioned with myloablative conditioning (MAC) versus reduced-intensity conditioning (RIC) and to determine the effect of a new oral care protocol

A radiographic full-mouth exam and an oral exam by an investigating dentist were performed one week prior to hematopoietic stem cell transplantation (HSCT). Prior to the start of conditioning, daily oral exams began three days prior to HSCT for 25 days or until discharge. A dentist or dental hygienist assessed oral cavities three times per week. From 2007 to 2010, 142 patients used a protocol (soft tooth brushing twice daily only; no interdental brushes, toothpicks, or flossing were allowed). From 2010 to 2011, 29 patients received the intensive protocol (intensive protocol brushing, interdental brushes or flossing, sucking on ice chips every two to three hours while awake, rinsing normal saline solution every two hours while awake from transplantation until neutrophil count was > 0.5). Dental infections foci were treated conservatively.

• N = 171
• MEDIAN AGE = 50 years
• MALES: 53.2%, FEMALES: 46.7%
• KEY DISEASE CHARACTERISTICS: Allogeneic HSCT; 94% malignant disease; 5% nonmalignant; 12% previous HSCT; 44% early-stage; 56% late-stage
• OTHER KEY SAMPLE CHARACTERISTICS: 57 human leukocyte antigen identical sibling or related donors; 101 unrelated donors; 13 antigen-mismatched, unrelated donors

• SITE: Single-site
• SETTING TYPE: Inpatient
• LOCATION: Karolinska University Hospital in Huddinge, Sweden

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Pediatrics, elder care

Quasi-experimental

• World Health Organization (WHO)
• Visual Analog Scale (VAS) for pain
• National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE v3)
• Oral function (ability to swallow)
• Subjective opinion of function of saliva

Patients treated with the oral protocol in 2011 had significantly lower OM scores than those treated with the previous protocol (p = 0.013).

MAC conditioning was correlated with significantly higher OM scores (p < 0.001). Lower OM scores were associated with the intensive oral protocol intervention. Patients treated in later years (2011) demonstrated a decrease in OM scores, which were caused by an increased use of RIC and improved standards of oral care.

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Measurement/methods not well described
• Other limitations/explanation: The actual sample size for the oral care intervention was only 29 participants. In addition, the authors began the article comparing different conditioning regimens then added in the oral care intervention.

Oral mucositis is a side effect of the conditioning regimens for HSCT. This study revealed that with consistent assessment, support, and a more intensive oral care protocol using ice and normal saline rinses, there is a potential to reduce the severity of this side effect. More nursing research is needed in this area.

To compare, in patients undergoing breast reconstruction, the efficacy of levobupivacaine in conjunction with oral paracetamol and IV morphine to the efficacy of placebo in conjunction with oral paracetamol and IV morphine

Levobupivacaine 2.5 mg/ml or normal saline (NS) was administered through an indwelling catheter every 3 hours for 45 hours with

• Four doses of paracetamol, 1 gm each, starting one hour before surgery
• IV PCA morphine, 2 mg/dose every 6 minutes

• The sample was composed of 34 patients.
• The age range of patients was 34–71 years.
• All patients were female.
• All patients were undergoing delayed breast reconstruction after previous mastectomy for breast cancer. All mastectomies were unilateral, with or without reduction on the other side or augmentation mammaplasty.

• Single setting
• Inpatient
• University hospital, Stockholm, Sweden

Prospective placebo-controlled, double-blind study

• 100 mm visual analog scale (VAS)
• Use of morphine (opioid consumption)
• Measure of nausea
• Measure of infection
• Length of hospital stay
• Time to request for rescue analgesic

When patients were at rest, levobupivacaine significantly reduced pain (p < 0.05) 15 hours postoperatively. With movement, levobupivacaine significantly reduced pain for 6 hours (p = 0.01) and significantly reduced pain for 18–24 hours (p = 0.045). Total dose of morphine used did not differ between groups. Two patients in the levobupivacaine group became infected. Authors noted no significant intergroup differences related to nausea or length of hospital stay.

Compared with patients who received placebo, those who were intermittently injected with levobupivacaine had better pain relief at rest for the first 15 hours after surgery. Those who received intermittently injected levobupivacaine also had better pain relief during mobilization, for the first 6 hours and for 18–24 hours.

• The study had a small sample size, with fewer than 100 participants.
• Variations in pain site and surgical technique could have contributed to the intensity of postoperative pain.

Boluses of local anesthetic, delivered via patient-controlled anesthesia, tend to have good results because patients prefer to control their own treatment.