Clinical trial NCT04837014: Eliminating Narcotic Prescriptions from Outpatient Minimally Invasive Gynecologic Surgery
Official title: Eliminating Narcotic Prescriptions from Outpatient Minimally Invasive Gynecologic Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Opioid Use
Keywords: Gynecology
Minimally invasive surgery
Laparoscopy
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain score on post-operative day one
timeFrame: Post-operative day one
Secondary outcomes:
measure: Patient mobility and satisfaction of analgesia
timeFrame: Post-operative day one and seven
measure: Total narcotic consumption in the first post-operative week
timeFrame: Post-operative day seven
measure: Opioid related side effect
timeFrame: First post-operative week (Day 7)
measure: Unplanned return to emergency room / clinic
timeFrame: First post-operative week (Day 7)
measure: Overall satisfaction with pain control
timeFrame: First post-operative week (Day 7)
measure: Pain score on post-operative day one
timeFrame: Post-operative day 7
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Center
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Andrew Zakhari, M.D.
role: PRINCIPAL_INVESTIGATOR
References: