The effect of triple vs. double nonopioid therapy on postoperative pain and functional outcome after abdominal hysterectomy: a randomised double-blind control trial.

ABSTRACT

BACKGROUND: Movement-evoked pain is more severe than pain at rest and is likely to interfere more with functional recovery after surgery. OBJECTIVE: To compare triple vs. double nonopioid perioperative analgesic regimens in women undergoing abdominal hysterectomy. DESIGN: A randomised, parallel design, double-blind controlled trial. SETTING: A single-centre trial. Study period from November 2009 to July 2013. PATIENTS Adults (>18 years) of American Society of Anesthesiologists' status 1 to 2 scheduled for abdominal hysterectomy. INTERVENTIONS: Patients were randomised to one of four study treatment groups acetaminophen, meloxicam and gabapentin (AMG); acetaminophen and meloxicam; acetaminophen and gabapentin; and meloxicam and gabapentin. In addition to intravenous patient-controlled opioid analgesia, study treatments were administered for 48 h, starting 1 h preoperatively. MAIN OUTCOME MEASURES: The primary outcome was cough-evoked pain. Secondary outcomes included pain at rest, during sitting and peak expiration, opioid consumption, side effects, peak expiratory flow rate, timed up and go test (TUG), and modified Brief Pain Inventory (mBPI). RESULTS: Interim analysis indicated a minimal chance of demonstrating superiority of the triple regimen group over all three double regimen groups if the trial were to be recruited to planned sample size. Thus, the trial was prematurely terminated for futility. All four analgesic regimens were well tolerated. Exploratory analyses revealed consistent significant negative correlations between pain and TUG and between pain and interference with activity, walking and sleep. CONCLUSION: This trial failed to demonstrate substantial benefits with the addition of a third nonopioid analgesic to three different double-drug regimens. Further research is needed that will more definitively support expanding multimodal analgesic practices. Our results demonstrate consistent correlations between evoked pain and functional outcomes further emphasising the need for improved analgesic regimens that will accelerate postsurgical functional recovery. TRIAL REGISTRATION International Standard Randomised Controlled Trial Number Register 12723675.