Eliminating Narcotic Prescriptions from Outpatient Minimally Invasive Gynecologic Surgery

NCT04837014 | Completed

• 1 other identifier: F11-70846
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Gynecology; Minimally invasive surgery; Laparoscopy

Outcome Measures

Primary Outcomes (1)

• Pain score on post-operative day one

  The primary outcome of this study is patient reported pain using an 11-point Numerical Rating Scale (NRS) on post-operative day two, on a scale from 0 to 10 in which higher scores indicate higher pain (worse pain control).

  Post-operative day one

Secondary Outcomes (6)

• Patient mobility and satisfaction of analgesia

  Post-operative day one and seven

• Total narcotic consumption in the first post-operative week

  Post-operative day seven

• Opioid related side effect

  First post-operative week (Day 7)

• Unplanned return to emergency room / clinic

  First post-operative week (Day 7)

• Overall satisfaction with pain control

  First post-operative week (Day 7)

Study Arms (2)

Acetaminophen and naproxen only arm

EXPERIMENTAL

Patient allocated to the intervention arm will be discharged home with a prescription for regular acetaminophen and naproxen for 48 hours, and then as needed for one week's duration.

Other: prescription for regular acetaminophen and naproxen

Acetaminophen, naproxen and dilaudid arm

ACTIVE COMPARATOR

Patient allocated to the control group will be discharged home with a prescription for regular acetaminophen, naproxen, and 5 tabs of hydromorphone 1 mg, with instruction to prioritize non opioid analgesic as first line.

Other: prescription for regular acetaminophen , naproxen and dilaudid

Interventions

prescription for regular acetaminophen and naproxen OTHER

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.

Acetaminophen and naproxen only arm

prescription for regular acetaminophen , naproxen and dilaudid OTHER

prescription for regular acetaminophen , naproxen and dilaudid

Acetaminophen, naproxen and dilaudid arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women undergoing elective outpatient gynecologic laparoscopy
• Able to provide informed consent
• Planned for same day discharge

You may not qualify if:

• Chronic pain conditions including, but not limited to: chronic pelvic pain, fibromyalgia, connective tissue disorders, migraines on medication, severe osteoarthritis, sciatica, degenerative disk disease
• Regular use of analgesia or narcotics. Defined as use of pain medication on most days of the week, most weeks of the month
• History of substance abuse (opioid addiction, IV drug use, etc.)
• Known depression or anxiety conditions with or without medication
• Eastern Cooperative Oncology Group (ECOG) performance status 3 or greater
• Current or recent use of pain modulators such as pregabalin or gabapentin (one month pre-operatively).
• Allergy or contraindication to acetaminophen or NSAIDs or hydromorphone/narcotics
• Intraoperative complications :
• Conversion to laparotomy or mini-laparotomy \> 4 cm
• Intra-operative gastrointestinal or urologic injury
• Intra-operative hemorrhage or need for blood transfusion
• Need for admission

Sponsors & Collaborators

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

Study Sites (1)

McGill University Health Center

Montreal, Quebec, H4A 3J1, Canada

Location

Related Publications (1)

• Zakhari A, Desilets J, Della Rocca C, Shan WLP, Nguyen DB, Gilbert L, Smith JP, Krishnamurthy S, Mansour FW. Eliminating opioid prescriptions from outpatient minimally invasive gynecologic surgery: a randomized trial. Nat Med. 2026 Jan 5. doi: 10.1038/s41591-025-04096-6. Online ahead of print.

  PMID: 41491106 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Prescriptions; Naproxen; Hydromorphone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Services; Health Services; Health Care Facilities Workforce and Services; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes

Study Officials

• Andrew Zakhari, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Although the patient and operative team will not be blinded to the allocation, the research team member completing the post-operative questionnaires as well as the statistician responsible for data analysis will remain blinded to the allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: In this randomized controlled trial, consented patient will be randomly allocated to either intervention or control groups in a 1:1 fashion. Allocation will be determined by a computerized randomization generator with block randomization in groups of four. Allocations will be placed in sequentially numbered, sealed, opaque envelopes to be opened only upon completion of surgery of consenting patients.

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 8, 2021
• Study Start: July 4, 2022
• Primary Completion: October 15, 2024
• Study Completion: October 21, 2024
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)