Patient-Based Decision-Making for Opioid Prescriptions after Ambulatory Breast Operation: A Randomized Clinical Trial

Opioids are routinely prescribed after ambulatory breast surgery despite low reported pain, increasing risk of misuse and diversion. We conducted a randomized clinical trial to determine whether a patient opt-in prescribing strategy reduces opioid prescription, consumption, and excess without worsening postoperative pain or quality of life.

Adults undergoing ambulatory breast surgery at a single tertiary center (2022 to 2024) were randomized 1:1 to Postoperative Opt-In Opioid Treatment (POINT) or routine opioid prescription. POINT patients received education and were prescribed opioids only on request. Primary outcome was peak pain scores 0 to 10 on the numeric pain rating scale on postoperative days 1 to 7 (noninferiority margin 2 points). Secondary outcomes included opioids prescribed, consumed, excess (prescribed minus consumed), PROMIS-29 quality-of-life change, and predictors of opioid use.

Of 107 patients, 56 were randomized to POINT and 51 to control. In the POINT, 37 (66%) opted out and 19 (34%) opted in. Prescription rates were 35% in POINT vs 100% in controls (absolute reduction 65%). Nine percent were consumers vs 24% consumed opioids (absolute reduction 15%). A total of 111 pills were prescribed in POINT vs 362 in controls vs (median 0 [interquartile range (IQR) 0 to 5] vs median 6 [IQR 5 to 7], p < 0.0001), with excess of 95 vs 293 pills (median 0 [IQR to 5] vs 6 [IQR 5 to 7], p < 0.0001). Total pills consumed were 63 vs 16, although most patients used none (median 0 [IQR 0] in both groups, p = 0.04). Peak pain scores and quality-of-life scores did not differ. Pain scores independently predicted opioid use (odds ratio 2.14, 95% CI 1.41 to 3.26; p = 0.00037).

A patient opt-in strategy reduced opioid prescribing, consumption, and excess without worsening pain or quality of life after ambulatory breast surgery.