Lavu, H., Lengel, H.B., Sell, N.M., Baiocco, J.A., Kennedy, E.P., Yeo, T.P., . . . Yeo, C.J. (2015). A prospective, randomized, double-blind, placebo controlled trial on the efficacy of ethanol celiac plexus neurolysis in patients with operable pancreatic and periampullary adenocarcinoma. Journal of the American College of Surgeons, 220, 497–508.

DOI Link

Study Purpose

To examine the efficacy of celiac plexus neurolysis on pain in patients receiving surgical resection for locally advanced disease

Intervention Characteristics/Basic Study Process

Patients who were identified as having unresectable disease underwent open biopsies if indicated and palliative biliary or gastrointestinal bypasses as deemed appropriate. Once it was determined that resection was appropriate, patients were randomly assigned to receive the study intervention or a placebo of normal saline injections. Postoperative pain control consisted of intravenous patient-controlled analgesia. For the analysis, patients were grouped according to resectability and the presence of pain at baseline. Patients were followed for 24 months. Pain was evaluated via patient surveys done every three months. Celiac plexus neurolysis has been shown to reduce pain in patients with advanced pancreatic cancer.  

Sample Characteristics

  • N = 467  
  • MEAN AGE = 76.5 years
  • MALES: 54%, FEMALES: 44%
  • KEY DISEASE CHARACTERISTICS: Pancreatic cancer

Setting

  • SITE: Single site  
  • SETTING TYPE: Not specified    
  • LOCATION: Thomas Jefferson University Hospital

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care
  • APPLICATIONS: Palliative care 

Study Design

Double-blinded, placebo-controlled, randomized, controlled trial

Measurement Instruments/Methods

  • Brief Pain Inventory (BPI)
  • Functional Assessment of Cancer Therapy (FACT) hepatobiliary

Results

There were no significant differences in postoperative complications between groups. There were no overall significant differences in pain scores over time between groups. A subgroup analysis showed a reduction in pain at three to nine months among patients with pain at baseline who received surgical resection. There were no differences in pain results from the addition of neurolysis.

Conclusions

This study showed that palliative surgical resection reduced pain as many as nine months after surgery, and that there was no added benefit from celiac neurolysis.

Limitations

  • Subject withdrawals ≥ 10% 
  • Other limitations/explanation: No information about the use of analgesics or other interventions for pain during the study period was provided. Low survey response rates were reported at various time points; however, it was difficult to find the actual number of respondents at various measurement points.

Nursing Implications

A number of studies have shown that celiac neurolysis is effective in reducing pain among patients with chronic pain associated with unresectable pancreatic cancer. This study suggested that, for those patients where palliative resection is possible, that resection is more effective than neurolysis and that neurolysis in addition to resection did not appear to have additional benefit. There were a number of important limitations in this study. However, it pointed to the value of additional research in this area to determine the most beneficial approaches for long-term pain control in this group of patients.