Pilot Trial: Postoperative Opioid-free Analgesia

Status Completed

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

Clinical Trial Details

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

View Details

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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.