18 and older, female only, with Surgery. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Oxycodone Tablets Used Day 1Primary· 24 hours post-operative
During the survey phone call on day 1, participants will be asked to report the total number of oxycodone tablets use since the surgery.
Group
Value
95% CI
Number of Oxycodone Tablets Typically Prescribed
1.0
0.0 – 1.0
Half the Number of Oxycodone Tablets Typically Prescribed
1.0
0.0 – 1.0
Number of Oxycodone Tablets Used as Reported by Participants 1 Week After SurgeryPrimary· 7 days post-operative
During the survey phone call on day 7, participants will be asked to report the total number of oxycodone tablets used since the surgery.
Group
Value
95% CI
Number of Oxycodone Tablets Typically Prescribed
2.5
0.0 – 5.0
Half the Number of Oxycodone Tablets Typically Prescribed
2.0
0.0 – 4.0
Self Reported Pain Score on Post Operative Day 1 (Numeric Pain Reporting Score: NRS)Secondary· 1 day post operative
Participants will be surveyed during the phone call survey to rate pain score on a scale from 0 (no pain), to 10 (severe pain)
Group
Value
95% CI
Number of Oxycodone Tablets Typically Prescribed
5.0
3.0 – 7.0
Half the Number of Oxycodone Tablets Typically Prescribed
5
2.0 – 6.0
Self Reported Pain Score on Post Operative Day 7 (Numeric Pain Reporting Score: NRS)Secondary· 7 days post operative
Participants will be surveyed during the phone call survey to rate pain score on a scale from 0 (no pain), to 10 (severe pain)
Group
Value
95% CI
Number of Oxycodone Tablets Typically Prescribed
2.0
0.0 – 4.0
Half the Number of Oxycodone Tablets Typically Prescribed
1.3
0.0 – 3.3
Additional Contacts With ProviderSecondary· 1 week post operative
By chart review, unscheduled interactions with the healthcare system related to pain will be counted.These will include phone calls related to pain, unscheduled visits to the office or emergency department
Group
Value
95% CI
Number of Oxycodone Tablets Typically Prescribed
1
Half the Number of Oxycodone Tablets Typically Prescribed
4
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Montefiore Medical Center
Last refreshed: 13 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03588910.