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NCT03588910 · ClinicalTrials.gov registry record · Phase 2
Ambulatory Gynecologic Surgery: Finding the Optimal Opioid Prescription
A Phase 2 study of Surgery, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT03588910: Completed Phase 2 study of Surgery, sponsored by Montefiore Medical Center.
NCT03588910 is a Phase 2 study of Surgery that has completed, run by Montefiore Medical Center. The registered enrollment target is 120 participants, below the 52,851-participant average among 120 other Surgery trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03588910, a Phase 2 study of Surgery, has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
During the survey phone call on day 1, participants will be asked to report the total number of oxycodone tablets use since the surgery.
Conditions Studied
Interventions
- DRUG Ibuprofen 600 mg
- DRUG Acetaminophen
- DRUG Oxycodone
Study Locations (1)
New York
- Montefiore Medical Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2018-08-08 |
| Est. Completion | 2019-08-04 |
| Phase | Phase 2 |
What the finished NCT03588910 record still lists
NCT03588910 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 52,851-participant average among 120 other Surgery trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Surgery appearing as the primary indexed condition, and to 3 interventions - of which Ibuprofen 600 mg is the first listed.
NCT03588910 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03588910 about?
NCT03588910 is a clinical study titled "Ambulatory Gynecologic Surgery: Finding the Optimal Opioid Prescription". 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...
What is the current status of trial NCT03588910?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2018-08-08. Estimated completion is 2019-08-04.
What conditions does trial NCT03588910 study?
This clinical trial studies the following conditions: Surgery.
What interventions are being tested in trial NCT03588910?
The interventions under investigation include: Ibuprofen 600 mg (DRUG), Acetaminophen (DRUG), Oxycodone (DRUG).
Who is sponsoring clinical trial NCT03588910?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03588910 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Surgery
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Where NCT03588910's enrollment target sits among peer trials
120 53rd of 120 higher than 68 of 120 other Surgery trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Surgery trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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