Eliminating Narcotic Prescriptions From Outpatient Minimally Invasive Gynecologic Surgery

Last updated on July 2021

Recruitment

Recruitment Status: Not yet recruiting
Estimated Enrollment: Same as current

Summary

Conditions

Opioid Use
Pain Postoperative

Type

Interventional

Phase

Not Applicable

Design

Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 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.Masking: Double (Investigator, Outcomes Assessor)Masking Description: 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.Primary Purpose: Prevention

Participation Requirements

Age: Between 18 years and 125 years
Gender: Only males

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.

Tracking Information

NCT #: NCT04837014
Collaborators: Not Provided
Investigators: Principal Investigator: Andrew Zakhari, M.D. McGill University Health Centre/Research Institute of the McGill University Health Centre