Johnson, C.D., Berry, D.P., Harris, S., Pickering, R.M., Davis, C., George, S., . . . Sutton, R. (2009). An open randomized comparison of clinical effectiveness of protocol-driven opioid analgesia, celiac plexus block or thoracoscopic splanchnicectomy for pain management in patients with pancreatic and other abdominal malignancies. Pancreatology: Official Journal of the International Association of Pancreatology 9(6), 755–763.doi: 10.1159/000199441
To assess the effectiveness, after two months, of celiac plexus block (CPB) versus thoracoscopic splanchnicectomy (TS) in patients receiving appropriate medical management (MM) for the pain of pancreatic and other abdominal malignancies
Patients were randomized to one of three treatment groups (MM, MM+CPB, or MM+TS) in blocks of three, stratified by treatment center, tumor type, and current opioid status (opioid naive, not taking strong opioids or started strong opioids within three days before recruitment, or taking strong opioids for more than three days prior to recruitment). Clinical assessments and data collection occurred at randomization, at weeks 2 and 4, and then monthly. Local researchers were not blinded to procedure. Patients completed a daily diary for two months and completed questionnaires at follow-up visits. Oral modified-release morphine was prescribed according to standard practice in each setting and increased 30%–50% as needed for pain control. Rescue medication for breakthrough pain was immediate-release oral morphine. Adjuvant analgesic agents—including amitriptyline, valproate, or gabapentin—were also used as needed for neuropathic pain. NSAIDs or dexamethasone was used for liver capsule pain. Opioid switching occurred as needed to avoid side effects or because of a patient's inability to take oral medications. Opioid rotation was not used. Patients maintained a daily diary of pain assessment.
Open randomized comparison
Pain relief was achieved in one third of patients at two weeks and in just under half of all patients at two months. Researchers observed no differences between groups in pain scores or total opioid consumption at any time point. Two months after randomization, 73% of subjects were taking opioids. Four serious adverse events occurred in three patients: One patient in the MM group was hospitalized for confusion eventually thought to be unrelated to the study medication, one patient was hospitalized for wound infection after TS, and one patient in the TS group had intraoperative bleeding that was resolved with sutures. Of all participants, 53% took opioids regularly during the study and 11.8% took adjuvant analgesics. Worst pain and average pain declined somewhat in all groups.
Authors reported no significant intergroup differences in pain scores or opioid consumption and no correlation between continued use of opioids and effective pain relief. The absence of any benefit from interventions led researchers to question the value of the interventions.
The study presents insufficient evidence to support the efficacy of one treatment over the others.