Clinical trial NCT04254679: Pilot Trial: Postoperative Opioid-free Analgesia
Official title: Opioid-free Analgesia After Outpatient General Surgery: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Outpatient Surgery
Abdominal Surgery
Breast Surgery
Keywords: Opioids
Surgery
Postoperative Period
Postoperative Pain
Analgesia
Pain Management
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Society of American Gastrointestinal and Endoscopic Surgeons
First posted: 2020-02-05
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will be a parallel, two-group, assessor-blind, pilot randomized trial.
Primary purpose: TREATMENT

Brief summary: North America is facing an opioid epidemic fueled by surgeons, who are the second largest subgroup of physicians involved in opioid prescribing. Surgery often serves as the initial event for opioid-naïve patients to obtain a prescription for opioids and spiral into misuse and addiction. From the perspective of perioperative care clinicians, the answer to the opioid crisis may be using opioid-free analgesia. However, the number of comparative studies in this field is limited and existing small trials do not reflect current standards of care in North America. Lack of evidence means that the decision to prescribe opioids after outpatient surgery largely depends on surgeon preference and healthcare culture. Hence, there is an urgent need for a robust randomized controlled trial (RCT) to guide clinical decision-making. The feasibility and optimal design of this RCT should be informed by a pilot trial. The overarching goal of this pilot RCT is to investigate the feasibility of conducting a full-scale RCT to assess the comparative-effectiveness of opioid versus opioid-free analgesia after outpatient general surgery.

Detailed description: This study will be a pragmatic, parallel, two-group, assessor-blind, pilot RCT. The investigators aim to recruit 80 adult patients at two tertiary hospitals in Montreal. Eligibility criteria will span outpatient procedures in abdominal and breast surgery. Patients are randomized on a 1:1 ratio to treatment with either opioid (standard care) or without opioid (only non-opioid analgesics). Patients will be followed up for 3 months after surgery; postoperative day (POD) 1 to POD 7 and at 2, 3 and 4 weeks after surgery, and at 3 months. Assessments will include postoperative pain, physical and mental function, adverse drug events, prolonged opioid use and opioid misuse. Feasibility outcomes will include the number of patients screened, consented and randomized, adherence with treatment and completion of follow-up. Data from this pilot study will inform the calculation of sample size requirements for the full-scale RCT. An embedded qualitative study will be conducted to help optimize trial design based on clinicians' and patients' perspective.

Eligibility criteria: Inclusion Criteria:

Adult patients (\>18 yo) undergoing outpatient surgery

* Abdominal surgery (i.e. cholecystectomies, hernia repairs, ovarian cystectomies, salpingectomies)
* Breast surgery (i.e. lumpectomies, partial and complete mastectomies, axillary node dissections)

Exclusion Criteria:

All patients

* Intraoperative or early postoperative complications (i.e. diagnosed in the Post-Anesthesia Care Unit (PACU)) that require postoperative hospital stay
* Contraindications to any of the drugs used in the trial
* Difficult to be reached after surgery
* Inability to provide written informed consent

Primary outcomes:
measure: Percentage of Screened Participants Who Were Eligible to Participate in the Study
timeFrame: 4 months
measure: Percentage of Surgeons Agreeing and Adhering to Patient Randomization
timeFrame: 4 months
measure: Percentage of Eligible Patients Agreeing to Participate
timeFrame: 4 months
measure: Percentage of Randomized Patients Complying With Allocated Treatment
timeFrame: 4 months
measure: Percentage of Randomized Patients Completing the 30-day Postoperative Outcome Assessment
timeFrame: 4 months
measure: Percentage of Missing Data Among All Questionnaires Distributed to Patients Who Completed the Assessments
timeFrame: 4 months
measure: Percentage of Missing Data Among All Questionnaire Items Distributed to Patients Who Completed the Assessments
timeFrame: 4 months
Secondary outcomes:
measure: Postoperative Pain
timeFrame: 30 days.
measure: Time to Stopping Pain Medication
timeFrame: 30 days.
measure: Postoperative Health Status
timeFrame: Weeks 1, 2, 3 and 4 after surgery.
measure: Opioid Side-effects
timeFrame: Postoperative days 1 to 7, weeks 2, 3 and 4 after surgery
measure: Rate of Opioid Misuse
timeFrame: 4 weeks
measure: Postoperative Complications Classification
timeFrame: 30 days.
measure: Rate of Unplanned Healthcare Utilization
timeFrame: 30 days.
measure: Rate of Adverse Drug Events
timeFrame: 30 days after surgery
measure: Rate of Prolonged Opioid Use
timeFrame: 3 months
measure: Comprehensive Complication Index at 30-day
timeFrame: 30 days
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
References:
citation: Do U, El-Kefraoui C, Pook M, Balvardi S, Barone N, Nguyen-Powanda P, Lee L, Baldini G, Feldman LS, Fiore JF Jr; McGill Better Opioid Prescribing Collaboration; Alhashemi M, Antoun A, Barkun JS, Brecht KM, Chaudhury PK, Deckelbaum D, Di Lena E, Dumitra S, Elhaj H, Fata P, Fleiszer D, Fried GM, Grushka J, Kaneva P, Khwaja K, Lapointe-Gagner M, McKendy KM, Meguerditchian AN, Meterissian SH, Montgomery H, Rajabiyazdi F, Safa N, Touma N, Tremblay F. Feasibility of Prospectively Comparing Opioid Analgesia With Opioid-Free Analgesia After Outpatient General Surgery: A Pilot Randomized Clinical Trial. JAMA Netw Open. 2022 Jul 1;5(7):e2221430. doi: 10.1001/jamanetworkopen.2022.21430.