A Randomized Controlled Non-Inferiority Trial of Reduced Versus Routine Opioid Prescription after Prolapse Repair.

Publication date: Mar 18, 2020

Given the accelerating opioid crisis in the United States and evidence that patients use less opioid than prescribed, surgeons may choose to decrease prescribed quantities. The effect this may have on patient satisfaction with pain control after hospital discharge is unknown.

The primary objective of this study was to compare patient satisfaction with postoperative pain control between patients receiving a routine or reduced quantity opioid prescription after prolapse repair. Secondary objectives included a comparison of opioid-related side effects, number of opioid tablets used, and the number of excess tablets prescribed between these groups.

This was a single-center, unmasked, two-arm, randomized controlled non-inferiority trial of women undergoing a prolapse repair with a planned overnight hospitalization. Patients were randomized to one of two study arms: routine (28 tablets of oxycodone 5mg) or reduced (5 tablets) prescription of opioid tablets. Patients were eligible if they were at least 18 years of age and undergoing a prolapse repair with an anticipated overnight hospital stay. Exclusion criteria included a history of chronic pain, preoperative opioid use, intolerance to study medication, or a score of 30 or greater on the Pain Catastrophizing Scale. In addition to their opioid prescription, all patients received multimodal pain medications at discharge. Patients were asked to complete six weeks of diaries to record pain and medication use. The primary outcome (patient satisfaction) was collected as part of a postoperative survey completed at patients’ routine postoperative visit six weeks after surgery. Sample size for non-inferiority was calculated at 59 patients per group for a total of 118 patients.

118 patients were randomized, and the primary outcome was available for 116. The majority of patients were white, post-menopausal, and non-smokers; the mean age was 62+/-10.4 years. The most common surgery was a hysterectomy with native tissue repair (n=71, 60%). 110 (93%) patients were satisfied with postoperative pain control. Statistical analysis constructed for non-inferiority showed that the difference between the groups was less than 15% (93% vs 93%, p=0.005). Subjects in the reduced arm reported requiring an additional opioid prescription more frequently than in the routine arm (15% vs 2%, p=0.01). Patients in the routine arm used more opioid tablets than the reduced arm (median 3 [IQR 0-14] vs 1 [IQR 0-3]) but overall opioid utilization was low. As such, patients in the routine arm had significantly more unused opioid (median 26 [IQR 15-28] vs 4 [IQR 2-5]).

Patient satisfaction with pain control was non-inferior in patients receiving a reduced quantity of opioid after prolapse repair compared to those receiving a routine prescription. A large quantity of excess opioid was seen in both groups. Surgeons should consider prescribing five to ten tablets of opioid after prolapse repair surgery and consider applying these findings to postoperative prescribing after other gynecologic procedures.

Davidson, E.R.W., Paraiso, M.F.R., Walters, M.D., Propst, K., Ridgeway, B., Yao, M.M., and Ferrando, C.A. A Randomized Controlled Non-Inferiority Trial of Reduced Versus Routine Opioid Prescription after Prolapse Repair. 04809. 2020 Am J Obstet Gynecol.

Concepts Keywords
Chronic Pain History chronic pain
Hospital Reconstructive surgery
Hysterectomy Hysterectomy
IQR Repair surgery
Menopausal Psychoactive drugs
Multimodal RTT
Opioid Analgesics
Oxycodone Pain
Pain Morphinans
Pain Medication Opioids
Pain Medications Palliative care
Prolapse Pain management
Survey Oxycodone
Tablets Opioid use disorder
Versus Opioid epidemic


Type Source Name
disease MESH Prolapse
disease MESH satisfaction
drug DRUGBANK Oxycodone
disease MESH chronic pain
disease MESH Pain Catastrophizing
disease MESH smokers
drug DRUGBANK Pentaerythritol tetranitrate


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