Pilot Trial: Postoperative Opioid-free Analgesia

Abdominal Surgery Clinical Trial

Official title:

Opioid-free Analgesia After Outpatient General Surgery: A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04254679
• Other study ID #: MUHC REB 2020-5965
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 29, 2020
• Est. completion date: December 3, 2020

Study information

• Verified date: February 2021
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: December 3, 2020
• Est. primary completion date: September 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Surgery
• Breast Surgery
• Outpatient Surgery

Intervention

Drug:
• Opioid analgesics
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.
• Non-opioid analgesics
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.

Locations

Country	Name	City	State
Canada	McGill University Health Centre	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre	Society of American Gastrointestinal and Endoscopic Surgeons

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility: Rate of eligibility	At least 70% of patient undergoing the outpatient general surgery procedures of interest are eligible to be randomized.	4 months
Primary	Feasibility: Rate of acceptability of the trial by surgeons	At least 90% of the surgeons who agreed to have their patients randomized will comply with the agreement (i.e. not change their minds).	4 months
Primary	Feasibility: Rate of recruitment (acceptability of the trial by patients)	At least 50% of eligible patients agree to participate in the study and are randomized.	4 months
Primary	Feasibility: Rate of treatment compliance	At least 80% of the randomized patients comply with their allocated treatment (i.e. will take their pain medications as prescribed).	4 months
Primary	Feasibility: Rate of follow-up compliance	At least 80% of the patients randomized complete outcome assessment at 30-days after surgery.	4 months
Primary	Feasibility: Rate of missing questionnaire data	Among patients who complete outcome assessments, the proportion of missing data is less than 10% (i.e. non-response to questionnaires or specific questionnaire items).	4 months
Secondary	Postoperative pain	Measured using the Brief Pain Inventory Short-Form, which addresses pain severity and interference in the last 24 hours. Scores range from 0 to 10; higher scores represent worse pain outcomes.	30 days.
Secondary	Time to stopping pain medication	The time to the first report of stopping the use of pain medication.	30 days.
Secondary	Postoperative health status	Measured using the PROMIS-29 questionnaire, which assesses 7 domains of health (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference). Norm-based scores are calculated for each domain, such that a score of 50 represents the mean of the general population (standard deviation=10). Higher scores represent more of the domain being measured.	Weeks 1, 2, 3 and 4 after surgery.
Secondary	Opioid side-effects	Measured using the Perioperative Opioid-Related Symptom Distress Scale, which records symptom distress due to common adverse effects experienced by patients who receive opioids to relieve postoperative pain. Scores range from 0 to 4; higher scores represent worse symptoms.	Postoperative days 1 to 7, weeks 2, 3 and 4 after surgery
Secondary	Rate of opioid misuse	Measured using the Prescription Opioid Abuse Index, which includes questions regarding excessive dose, frequency of use, need for early refills, feeling high from the medication, taking the medication due to stress and obtaining prescriptions from multiple physicians. Scores range from 0 to 6; an affirmative answer to >1 question indicates the patient exhibits prescription opioid misuse.	4 weeks
Secondary	Postoperative complications (index)	Classified according to Clavien-Dindo and transformed into the Comprehensive Complication Index. Scores range from 0 (no complication) to 100 (death).	30 days.
Secondary	Rate of unplanned healthcare utilization	Emergency department visits, hospital readmissions.	30 days.
Secondary	Rate of adverse drug events	Obtained from spontaneous patient reporting (Trigger question "Did you have any significant medical problem related or unrelated to your surgery since the last study assessment?"). Events will be coded using the MedDRA coding dictionary, graded by severity according to the Common Terminology Criteria for Adverse Events (CTCAE) and assessed for potential causality using the WHO/UMC system.	30 days.
Secondary	Rate of prolonged opioid use	Filling of opioid prescriptions up to 3 months after surgery.	3 months