Phase 2
Completed N=120
Ambulatory Gynecologic Surgery: Finding the Optimal Opioid Prescription
Surgery
Source: ClinicalTrials.gov NCT03588910 ↗
Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcomePrimary: Number of Oxycodone Tablets Used Day 1 — 1.0; 1.0 Oxycodone Tablets — p=.87
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.
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 |
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
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. Informational only — not medical advice.