Phase 3
N=81
Pilot Trial: Postoperative Opioid-free Analgesia
Outpatient Surgery · Abdominal Surgery · Breast Surgery
Bottom Line
View on ClinicalTrials.gov: NCT04254679 ↗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
| Outcome | Result | p-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
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.