Phase 2 N=120 Randomized Single-blind Treatment

Ambulatory Gynecologic Surgery: Finding the Optimal Opioid Prescription

Surgery

Bottom Line

View on ClinicalTrials.gov: NCT03588910 ↗

Enrolled (actual)

120

Serious AEs

0.0%

Results posted

Aug 2021

Primary outcome: Primary: Number of Oxycodone Tablets Used Day 1 — 1.0; 1.0 Oxycodone Tablets — p=.87

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Acetaminophen (Drug); Ibuprofen 600 mg (Drug); Oxycodone (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Montefiore Medical Center
Primary completion: Jul 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Oxycodone Tablets Used Day 1	1.0; 1.0	.87
PRIMARY Number of Oxycodone Tablets Used as Reported by Participants 1 Week After Surgery	2.5; 2.0	.36
SECONDARY Self Reported Pain Score on Post Operative Day 1 (Numeric Pain Reporting Score: NRS)	5.0; 5	.91
SECONDARY Self Reported Pain Score on Post Operative Day 7 (Numeric Pain Reporting Score: NRS)	2.0; 1.3	.29
SECONDARY Additional Contacts With Provider	1; 4	.36

Summary

Currently there is a nationwide epidemic in opioid abuse and overdose deaths. While the opioid epidemic is multi-factorial one major source of excess opioids may be over-prescribing in the post-operative period. There is wide variation in the prescribing practices for post-operative pain control and there is no standard of care for pain control after minor laparoscopic surgery in general or after gynecologic laparoscopy. There is also evidence to show that on average half of the opioids prescribed are unused by the patient. The aim of the study is to evaluate two opioid prescription regimens.

Eligibility Criteria

Inclusion Criteria

Must be over 18 years of age
Scheduled for outpatient gynecologic laparoscopy

Exclusion Criteria

Significant renal or liver disease is present that would alter prescribing patterns
Chronic opioid use or abuse
Allergy to acetaminophen, ibuprofen, other nsaids or narcotic medications
Conversion of surgery to exploratory laparotomy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03588910). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.