Abstract
Introduction:
Postoperative pain management is an important clinical concern as it influences patient comfort and satisfaction, patient scores on government quality metrics, and length of stay. There are no studies examining pain management strategies following transsphenoidal surgery. Opioid medications are the most commonly used postsurgical pain medication class. Opioid-related adverse effects include respiratory depression, nausea, constipation, and altered mental status. Intravenous ibuprofen improves postoperative pain control and reduces opioid usage in orthopedic and general surgery patients. Herein, we present the results of an interim analysis of the first study examining pain management following transsphenoidal surgery. (ClinicalTrials.gov NCT02351700)
Objective:
This study has three objectives: 1) to compare the efficacy of two opioid-minimizing pain management regimens in a randomized, double-blinded, placebo-controlled study of intravenous ibuprofen, 2) to study postoperative pain scores and the factors that influence pain scores, and 3) to examine postoperative rescue opioid use.
Methods:
100 patients with planned transsphenoidal surgery will be randomized to one of two opioid-minimizing pain management regimens in a 1:1 allocation. The primary endpoint is patient pain scores (VAS) for 48 hours after surgery. Secondary endpoints include length of stay, opioid-related adverse events, anti-emetic use, bleeding complications, and pharmacy costs. Study inclusion criteria include adult, English-speaking, opioid naïve patients with planned transsphenoidal surgery for pituitary lesions. Exclusion criteria include opioid dependence, history of adverse reactions to study medications, renal disease, and liver disease. The study was approved by the local Institutional Review Board.
Results:
Study enrollment commenced on February 1, 2015 at the Barrow Neurological Institute. At the time of this abstract writing, 76 patients had been screened for eligibility, 32 were excluded, and 10 declined to participate. To date, 34 patients have completed the study. A planned interim analysis will be conducted when 40 patients have completed the study to determine study feasibility and preliminary results. The results of the interim analysis will be presented at the February meeting in Phoenix.
Discussion:
This is the first study to examined pain management strategies following transsphenoidal surgery. Interim data, which will be presented at the February meeting, will determine if the study endpoints are feasible and provide preliminary conclusions about the efficacy of opioid-minimizing pain strategies. When complete, this study will yield class 1 data to guide pain management.