Background
Postoperative opioid prescribing has historically lacked information crucial to balancing
the pain control needs of the individual patient with our professional responsibility
to judiciously prescribe these high-risk medications.
Objective
This study aimed to evaluate pain control, satisfaction with pain control, and opioid
use among patients undergoing isolated midurethral sling randomized to 1 of 2 different
opioid-prescribing regimens.
Study Design
Patients who underwent isolated midurethral sling placement from June 1, 2020, to
November 22, 2021, were offered enrollment into this prospective, randomized, open-label,
noninferiority clinical trial. Participants were randomized to receive either a standard
prescription of ten 5-mg oxycodone tablets provided preoperatively (standard) or an
opioid prescription provided only during patient request postoperatively (restricted).
Preoperatively, all participants completed baseline demographic and pain surveys,
including the 9-Question Central Sensitization Index, Pain Catastrophizing Scale,
and Likert pain score (scale 0–10). The participants completed daily surveys for 1
week after surgery to determine the average daily pain score, number of opioids used,
other forms of pain management, satisfaction with pain control, perception of the
number of opioids prescribed, and need to return to care for pain management. The
online Prescription Drug Monitoring Program was used to determine opioid filling in
the postoperative period. The primary outcome was average postoperative day 1 pain
score, and an a priori determined margin of noninferiority was set at 2 points.
Results
Overall, 82 patients underwent isolated midurethral sling placement and met the inclusion
criteria: 40 were randomized to the standard arm, and 42 were randomized to the restricted
group. Concerning the primary outcome of average postoperative day 1 pain score, the
restricted arm (mean pain score, 3.9±2.4) was noninferior to the standard arm (mean
pain score, 3.7±2.7; difference in means, 0.23; 95% confidence interval, −∞ to 1.34).
Of note, 23 participants (57.5%) in the standard arm vs 8 participants (19.0%) in
the restricted arm filled an opioid prescription (P<.001). Moreover, 18 of 82 participants (22.0%) used opioids during the 7-day postoperative
period, with 10 (25.0%) in the standard arm and 8 (19.0%) in the restricted arm using
opioids (P=.52). Of participants using opioids, the average number of tablets used was 3.4±2.3,
and only 3 participants used ≥5 tablets. On a scale of 1=“prescribed far more opioids
than needed” to 5=“prescribed far less opioids than needed,” the means were 1.9±1.0
in the standard arm and 2.7±1.0 in the restricted arm (P<.001).
Conclusion
Restricted opioid prescription was noninferior to standard opioid prescription in
the setting of pain control and satisfaction with pain control after isolated midurethral
placement. Participants in the restricted arm filled fewer opioid prescriptions than
participants in the standard arm. On average, only 3.4 tablets were used by those
that filled prescriptions in both groups. Restrictive opioid-prescribing practices
may reduce unused opioids in the community while achieving similar pain control.
Key words
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Article info
Publication history
Published online: May 09, 2022
Accepted:
May 2,
2022
Received in revised form:
April 29,
2022
Received:
January 3,
2022
Footnotes
The authors report no conflict of interest.
This trial was funded by an intramural grant. Study data were collected and managed using Research Electronic Data Capture (REDCap) electronic data capture tools hosted at Penn State Health Milton S. Hershey Medical Center and Penn State College of Medicine. This study received National Institutes of Health (NIH) funding for RedCap, which implies compliance with NIH public access policy.
This study was registered on ClinicalTrials.gov (identifier: NCT04277975; https://clinicaltrials.gov/ct2/show/NCT04277975). The clinical trial date of registration was on February 18, 2020. The date of initial participant enrollment was on June 1, 2020.
Individual participant data will be available. All individual participant data collected during the trial and after deidentification will be shared. The study protocol will be available. Data will be available immediately after publication, and there will be no end date. Data are available indefinitely at Data in Brief.
Cite this article as: Long JB, Morgan BM, Boyd SS, et al. A randomized trial of standard vs restricted opioid prescribing following midurethral sling. Am J Obstet Gynecol 2022;227:313.e1-9.
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