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Eliminating Narcotic Prescriptions from Outpatient Minimally Invasive Gynecologic Surgery

NCT04837014 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2024-10-24

No results posted yet for this study

Summary

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.

Conditions

  • Pain, Postoperative
  • Opioid Use

Interventions

OTHER

prescription for regular acetaminophen and naproxen

Patient allocated to the intervention arm will be discharged home with a prescription for regular acetaminophen and naproxen for 48 hours, and then prn for one week's duration. No narcotic will be prescribed at discharge post-operatively.

OTHER

prescription for regular acetaminophen , naproxen and dilaudid

prescription for regular acetaminophen , naproxen and dilaudid

Sponsors & Collaborators

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    lead OTHER

Principal Investigators

  • Andrew Zakhari, M.D. · McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-04
Primary Completion
2024-10-15
Completion
2024-10-21

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04837014 on ClinicalTrials.gov