Pilot Trial: Postoperative Opioid-free Analgesia

NCT04254679 | Completed Phase 2 Results

• 1 other identifier: MUHC REB 2020-5965
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Outpatient Surgery; Abdominal Surgery; Breast Surgery

Keywords

Opioids; Surgery; Postoperative Period; Postoperative Pain; Analgesia; Pain Management

Outcome Measures

Primary Outcomes (7)

• Percentage of Screened Participants Who Were Eligible to Participate in the Study

  At least 70% of patients undergoing the outpatient general surgery procedures of interest (screened participants) are eligible to be randomized.

  4 months

• Percentage of Surgeons Agreeing and Adhering to Patient Randomization

  At least 90% of the surgeons who agreed to have their patients randomized comply with the agreement (i.e. not change their minds).

  4 months

• Percentage of Eligible Patients Agreeing to Participate

  At least 50% of eligible patients agree to participate in the study and are randomized.

  4 months

• Percentage of Randomized Patients Complying With Allocated Treatment

  At least 80% of the randomized patients comply with their allocated treatment (i.e. will take their pain medications as prescribed).

  4 months

• Percentage of Randomized Patients Completing the 30-day Postoperative Outcome Assessment

  At least 80% of the randomized patients complete outcome assessment at 30 days after surgery.

  4 months

• Percentage of Missing Data Among All Questionnaires Distributed to Patients Who Completed the Assessments

  Among all questionnaires distributed to patients who complete outcome assessments, the proportion of missing data (i.e. non-response to questionnaires) is less than 10%.

  4 months

• Percentage of Missing Data Among All Questionnaire Items Distributed to Patients Who Completed the Assessments

  Among patients who complete outcome assessments, the proportion of missing data is less than 10% (i.e. non-response to specific questionnaire items).

  4 months

Secondary Outcomes (10)

• Postoperative Pain

  30 days.

• Time to Stopping Pain Medication

  30 days.

• Postoperative Health Status

  Weeks 1, 2, 3 and 4 after surgery.

• Opioid Side-effects

  Postoperative days 1 to 7, weeks 2, 3 and 4 after surgery

• Rate of Opioid Misuse

  4 weeks

Study Arms (2)

Opioid analgesia

EXPERIMENTAL

Drug: Opioid analgesics

Opioid-free analgesia

ACTIVE COMPARATOR

Drug: Non-opioid analgesics

Interventions

Opioid analgesics DRUG

Current standard of care in the participating centers Prescription of around-the-clock non-opioid analgesics (acetaminophen and/or NSAIDs/COX-2) and a supply of opioids to be used as a rescue in case of breakthrough pain. The specific round-the-clock analgesia and rescue opioid regimens will be determined by the patient's primary surgeon considering the surgical procedure, comorbidities and patient's preference.

Opioid analgesia

Non-opioid analgesics DRUG

Prescription of around-the-clock non-opioid analgesics (acetaminophen alone or combined with NSAIDs/COX-2). The specific non-opioid analgesia regimens will be determined by the patient's primary surgeon considering the surgical procedure, comorbidities and patient's preference.

Opioid-free analgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Society of American Gastrointestinal and Endoscopic Surgeons: collaborator

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H3G 1A4, Canada

Location

Related Publications (1)

• 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.

  PMID: 35849399 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Analgesics, Opioid; Analgesics, Non-Narcotic

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Results Point of Contact

• Title: Dr. Julio F. Fiore Jr
• Organization: McGill University

julio.fiorejunior@mcgill.ca

514 934-1934

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Patient-reported outcomes and treatment adherence data will be collected via self-administered electronic questionnaires distributed using REDCap (http://project-redcap.org/) and completed by patients via smartphone, tablet or personal computer. Electronic outcome data will be transmitted directly to the REDCap database and verified by a blinded assessor. Adherence data will be verified by unblinded study staff. Patients who are not computer savvy, have limited access or prefer non-electronic assessment will complete the questionnaires via telephone interviews with a blinded assessor; in this case, data will be recorded in paper forms and subsequently transferred to the REDCap database. Outcome data that are not patient-reported (e.g. postoperative complications, unplanned healthcare utilization, chronic opioid use), will be obtained from medical records by a blinded assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assitant Professor (McGill)

Model Details: This study will be a parallel, two-group, assessor-blind, pilot randomized trial.

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 5, 2020
• Study Start: January 29, 2020
• Primary Completion: September 20, 2020
• Study Completion: December 3, 2020
• Last Updated: November 20, 2024
• Results First Posted: November 20, 2024

Record last verified: 2024-09

Locations

CA (1)