Eliminating Narcotic Prescriptions from Outpatient Minimally Invasive Gynecologic Surgery (eNARCOS)

Eliminating Narcotic Prescriptions from Outpatient Minimally Invasive Gynecologic Surgery: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Opioid Use
• Intervention / Treatment: Other: prescription for regular acetaminophen and naproxen; Other: prescription for regular acetaminophen , naproxen and dilaudid

Detailed Description

Narcotic prescribing patterns vary greatly among gynecologists performing minimally invasive gynecologic surgery (MIGS). There is no clear consensus or established guideline regarding the choice of narcotic or total amount to be prescribed, if any, for MIGS. These represent a generally well-tolerated group of procedures that are less painful than conventional open surgery. Unnecessary opioid prescriptions and excess unused narcotics have been identified as major contributors to narcotic abuse in the community, and efforts geared towards minimizing unnecessary narcotic prescriptions may help curb the growing opioid crisis.

This study suggests eliminating opioids from discharge prescriptions following outpatient MIGS in select patients. Given the general tolerability and low pain associated with MIGS, the investigators hypothesize that elimination of narcotics from post-operative pain control, in conjunction with regular use of non-narcotic analgesics, will result in analgesia and early recovery that is no worse than a standard narcotic-containing discharge prescription.

Women undergoing elective outpatient laparoscopic gynecologic surgery at two medical center associated with the McGill University Health Centre will be recruited and screened for exclusion criteria. Patients will be randomly allocated to either intervention or control groups in a one to one fashion. Patients in both intervention and control group will undergo surgery under a standardized anesthesia protocol. Important surgical steps that can affect post-operative pain will be standardised and recorded with a surgical checklist to reduce inter-surgeon variability. Patient allocated to the intervention arm will then be discharged home with a prescription for regular acetaminophen and naproxen for 48 hours, and then as needed for one week's duration. Patient in control group will be discharge with a standard prescription of five tabs of 1 mg hydromorphone, with regular non-opioid analgesic use.

All patient will be contacted on day one and seven after surgery to evaluate pain scores, mobility, adequacy of analgesia, adherence to treatment, side-effects, and total opioid consumption.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acetaminophen and naproxen only arm; 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; 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.
Active Comparator: Acetaminophen, naproxen and dilaudid arm; 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; prescription for regular acetaminophen , naproxen and dilaudid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient mobility and satisfaction of analgesia	Patients will receive a phone call on post-operative day one and seven and will be asked a standardised set of questions binary question (Yes / No) to evaluate patient mobility and satisfaction of analgesia.	Post-operative day one and seven
Total narcotic consumption in the first post-operative week	Patients will receive a phone call on post-operative day one and seven and will be asked total amount of narcotic consumed since discharge from the hospital, including need for rescue prescription	Post-operative day seven
Opioid related side effect	Patients will receive a phone call on post-operative day one and seven and will be inquired about specific opioid side effect.	First post-operative week (Day 7)
Unplanned return to emergency room / clinic	Patients will receive a phone call on post-operative day one and seven and will be inquired about any unplanned visit to emergency room / clinic since discharged from the hospital.	First post-operative week (Day 7)
Overall satisfaction with pain control	Patients will receive a phone call on post-operative day one and seven and will be asked about overall satisfaction with pain control via standardised questionnaire.	First post-operative week (Day 7)
Pain score on post-operative day one	Patient reported pain using an 11-point Numerical Rating Scale (NRS) on post-operative day one, on a scale from 0 to 10 in which higher scores indicate higher pain (worse pain control).	Post-operative day 7

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Investigators: Principal Investigator: Andrew Zakhari, M.D., McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2022
• Primary Completion (Actual): October 15, 2024
• Study Completion (Actual): October 21, 2024

Study Registration Dates

• First Submitted: April 5, 2021
• First Submitted That Met QC Criteria: April 7, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): October 24, 2024
• Last Update Submitted That Met QC Criteria: October 22, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Gynecology; Minimally invasive surgery; Laparoscopy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Gout Suppressants; Antirheumatic Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Analgesics, Opioid; Narcotics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Acetaminophen; Naproxen; Hydromorphone
• Other Study ID Numbers: F11-70846

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No