Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04254679
Study type Interventional
Source McGill University Health Centre/Research Institute of the McGill University Health Centre
Contact
Status Completed
Phase Phase 2/Phase 3
Start date January 29, 2020
Completion date December 3, 2020

See also
  Status Clinical Trial Phase
Completed NCT01611376 - Impedance Cardiography During Major Abdominal Surgery Phase 4
Recruiting NCT05556174 - Intraoperative Lung Protective Ventilation Needs Periodic Lung Recruitment Maneuvers N/A
Completed NCT03633123 - D-PLEX 310: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection Phase 2
Terminated NCT03684304 - The Effect of Abdominal Binder Use on Postoperative Pain and Mobility in Patients Undergoing Pelvic Surgery N/A
Active, not recruiting NCT02817893 - Comparison of Respiratory Variations of the Pulse Oximetry Plethysmographic Raw Signal and Pulse Pressure During Abdominal Surgery (PLETHYSMO) N/A
Completed NCT04120740 - Validation of Two Acitivity Monitors in Three Inpatient Populations.
Recruiting NCT03700749 - FALCON Trial Testing Measures to Reduce Surgical Site Infection Phase 3
Completed NCT01389648 - Pre-operative Physiotherapy to Prevent Post-operative Complications N/A
Withdrawn NCT00557843 - Continuous Bupivacaine Infusion Following Colonic Surgery N/A
Active, not recruiting NCT01839617 - Study Comparing Early and Late Nutrition in Cancer Patients Undergoing Abdominal Surgery N/A
Terminated NCT04887922 - Preoperative and Postoperative Incentive Spirometry in Patients Undergoing Major Abdominal Surgery N/A
Completed NCT04730141 - Effect of Mobilization Protocol on Mobilization N/A
Completed NCT00683150 - Perioperative Kinetics of Reactive Hyperemia Using Noninvasive Digital Thermal Monitoring N/A
Active, not recruiting NCT03933306 - Intraoperative Goal-directed Blood Pressure and Dexmedetomidine on Outcomes Phase 4
Recruiting NCT05268432 - Development, Intraoperative Demonstration and Visualization of Surgical Assistance Functions
Not yet recruiting NCT04747535 - Continuous Positive Airway Pressure After Abdominal Surgery N/A
Not yet recruiting NCT05253586 - Versius Or Laparoscopic Abdominal Hernia REpair
Recruiting NCT06374849 - Intraoperative Sufentanil and Chronic Postsurgical Pain in Non-major Scheduled Abdominal Surgery Phase 4
Recruiting NCT05246605 - Postoperative Hypoxia and Body Position N/A
Recruiting NCT04685876 - Comparing TAP Blocks Bupivacaine, and Placebo for Plane Phase 3