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NCT04837014: eNARCOS
Eliminating Narcotic Prescriptions from Outpatient Minimally Invasive Gynecologic Surgery
NA trial testing prescription for regular acetaminophen and naproxen in Pain, Postoperative in 110 participants. Completed in 21 October 2024.
15 October 2024
Quick facts
| Lead sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 110 |
| Start date | 4 July 2022 |
| Primary completion | 15 October 2024 |
| Estimated completion | 21 October 2024 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- prescription for regular acetaminophen and naproxen
- prescription for regular acetaminophen , naproxen and dilaudid
Conditions studied
- Pain, Postoperative — all drugs for Pain, Postoperative →
- Opioid Use — all drugs for Opioid Use →
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Who can join
18 and older, female only, with Pain, Postoperative or Opioid Use. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Laparoscopic gynecologic surgeries are generally very well tolerated procedures, and patients are able to go home on the same day, with a prescription for pain control. There is currently a very wide range of prescription practice within the gynecology community in regards to opioids following surgery, and patients are going home with anything from zero to 5 or even 20 tabs of narcotics. Aside from negative side effect of opioids (like nausea/vomiting, dizziness, constipation, and possibly addiction), unnecessary opioid prescriptions and excess unused narcotics is one of the major contributors to narcotic abuse in the community, worsening an ongoing nationwide opioid crisis. Although most patients report low pain level following these kinds of procedure, there are no current standard prescriptions after gynecologic laparoscopy. In an effort to standardize discharge prescriptions following gynecologic laparoscopy, this study aims to find an optimal regimen for pain control in the post-operative period following laparoscopic gynecologic surgery. There will be 2 standardized set of discharge prescriptions to which patient will be randomized; both containing multimodal medications for pain control. Pain control, and patients satisfaction will be measured in the first post-operative week.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Eliminating opioid prescriptions from outpatient minimally invasive gynecologic surgery: a randomized trial.
Zakhari A, Désilets J, Della Rocca C, Shan WLP, et al · · 2026 · PMID 41491106 · DOI 10.1038/s41591-025-04096-6
Verify or expand the search:
- PubMed search for NCT04837014
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04837014 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre
- Last refreshed: 24 October 2024
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/NCT04837014.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing