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Phase 3 N=81 Randomized Single-blind Treatment

Pilot Trial: Postoperative Opioid-free Analgesia

Outpatient Surgery · Abdominal Surgery · Breast Surgery

Enrolled (actual)
81
Serious AEs
2.6%
Results posted
Nov 2024
Primary outcome: Primary: Percentage of Screened Participants Who Were Eligible to Participate in the Study — 163 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Opioid analgesics (Drug); Non-opioid analgesics (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Primary completion
Sep 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Screened Participants Who Were Eligible to Participate in the Study
163
PRIMARY
Percentage of Surgeons Agreeing and Adhering to Patient Randomization
15
PRIMARY
Percentage of Eligible Patients Agreeing to Participate
93
PRIMARY
Percentage of Randomized Patients Complying With Allocated Treatment
39; 36
PRIMARY
Percentage of Randomized Patients Completing the 30-day Postoperative Outcome Assessment
39; 34
PRIMARY
Percentage of Missing Data Among All Questionnaires Distributed to Patients Who Completed the Assessments
37
PRIMARY
Percentage of Missing Data Among All Questionnaire Items Distributed to Patients Who Completed the Assessments
33
SECONDARY
Postoperative Pain
0.9; 1; 2.8; 3; 2.7; 2.6
SECONDARY
Time to Stopping Pain Medication
9; 9
SECONDARY
Postoperative Health Status
50.2; 50.8; 44.9; 44.1; 47.2; 47.9
SECONDARY
Opioid Side-effects
16; 12; 4; 2; 18; 15
SECONDARY
Rate of Opioid Misuse
0.1; 0.1
SECONDARY
Postoperative Complications Classification
3; 1; 2; 0; 1; 1
SECONDARY
Rate of Unplanned Healthcare Utilization
6; 1; 5; 0; 1; 1
SECONDARY
Rate of Adverse Drug Events
4; 1; 0; 3; 1; 2
SECONDARY
Rate of Prolonged Opioid Use
25; 1; 0; 0; 0; 0
SECONDARY
Comprehensive Complication Index at 30-day
2.6; 0.9

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04254679). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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