Evaluating Routine Opioid Compared With Nonopioid Prescribing After Laparoscopic Hysterectomy: A Randomized...

To determine whether prescribing a nonopioid postoperative pain regimen after minimally invasive hysterectomy for benign indications is noninferior to prescribing routine opioids with respect to pain scores and patient satisfaction.

We conducted a noninferiority randomized controlled trial at an academic medical center from January 2023 to January 2024. Adult patients (age 18 years and older) undergoing laparoscopic or robotic hysterectomy for benign indications were randomized 1:1 to a nonopioid regimen (acetaminophen and ibuprofen) or a standard opioid regimen (acetaminophen, ibuprofen, and 12 5-mg oxycodone tablets). Participants in the nonopioid arm could request opioids if pain was inadequately controlled. Primary outcomes were pain scores on postoperative days 1 and 7, measured using the NRS-11 (11-point Numeric Rating Scale). Secondary outcomes included satisfaction with pain control and opioid consumption. The planned sample size of 60 participants was adequate for a predefined noninferiority margin of 1.5 points on the NRS-11.

Of 221 eligible patients screened, 71 consented; 64 were included in the final analysis (33 opioid, 31 nonopioid). Mean pain scores were similar between groups on postoperative day 1 (4.0 vs 5.0; difference -1.0; 97.5% CI, -2.2 to 0.2) and postoperative day 7 (2.1 vs 3.1; difference -1.0; 97.5% CI, -2.2 to 0.2), which met the criteria for noninferiority. Satisfaction with pain control was high in both groups. By postoperative day 7, median oxycodone consumption was 1 tablet in the opioid group and 0 in the nonopioid group.

Nonopioid postoperative pain management after minimally invasive hysterectomy is noninferior to routine opioid prescribing and substantially reduces opioid use, supporting opioid-sparing strategies in this population.

ClinicalTrials.gov , NCT05548582.