Optimizing Patient-centred Outcomes Using Opioid Minimization Strategies: The OPUS Anesthesia Pilot Trial (OPUS)

Optimizing Patient-centred Outcomes Using Opioid Minimization Strategies (OPUS) Anesthesia: a Pilot Randomised Controlled Trial

Up to 40% of patients experience suboptimal recovery in the days following major surgery, limiting their return to functional independence. Few preventive interventions exist, but intravenous dexmedetomidine and lidocaine administered during general anesthesia represent simple strategies that may significantly impact recovery and other patient-centred outcomes after surgery. The goal of this pilot trial is to determine the feasibility of conducting a phase 3 pragmatic adaptive multicentre trial to evaluate the impact of dexmedetomidine and lidocaine administered during major non-cardiac surgery on patient-centred outcomes.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Pain, Postoperative; Surgery; Anesthesia Morbidity; Anesthesia; Feasibility Studies; Anesthesia Complication; Patient-centredness
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: lidocaine; Other: control group

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sophie Guay, MSc; Phone Number: 66059 418-525-4444; Email: sophie.guay@crchudequebec.ulaval.ca

Study Locations

• Canada
  • Quebec
    • Lévis, Quebec, Canada, G6V3Z1
      • Recruiting
      • CISSS de Chaudière-Appalaches (Hôtel-Dieu de Lévis)
      • Contact: Emilie Côté; Phone Number: 418-835-7121; Email: Emilie.Cote.cisssca@ssss.gouv.qc.ca
    • Montreal, Quebec, Canada, H2X 0C1
      • Recruiting
      • Centre Hospitalier de l'Universite de Montreal (CHUM)
      • Contact: Vicky Thiffault; Phone Number: 20113 514 890-8000; Email: vicky.thiffault.chum@ssss.gouv.qc.ca
    • Québec, Quebec, Canada, G1J 1Z4
      • Recruiting
      • CHU de Québec-Université Laval (Hôpital de l'Enfant-Jésus)
      • Contact: Stéphanie Massana, BSc; Phone Number: 66060 418-525-4444; Email: stephanie.massana@crchudequebec.ulaval.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adults >/= 18 years.
2. Having elective major non-cardiac surgery (i.e., planned duration >/= 1.5 hours and anticipated >/= 1 night hospital stay).
3. Requiring general anesthesia.
4. Able to complete baseline quality of recovery assessment.

Exclusion Criteria:

1. Individuals with known contraindications to dexmedetomidine or lidocaine (e.g., allergy to alpha-2 agonists or local anesthetics, severe renal or hepatic failure, bradycardia or hypotension), as per routine assessment.
2. Regular use of alpha-2 agonists or local anesthetics prior to hospitalization.
3. Pregnant women.
4. Planned use of regional analgesia (i.e., epidural, peripheral nerve block, trunk nerve block) in conjunction with general anesthesia. Local anesthetics such as lidocaine are administered as part of regional analgesia technique. Combination with intravenous lidocaine is contraindicated to avoid exceeding therapeutic concentration.
5. Neurosurgical procedures except for spine surgery.
6. Planned postoperative intubation after PACU discharge.
7. No fixed address.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Usual care	Other: control group; Usual care where systemic dexmedetomidine is not allowed and systemic lidocaine is permitted only for the prevention or treatment of propofol injection pain.
Experimental: Intraoperative intravenous dexmedetomidine	Drug: Dexmedetomidine; Intravenous bolus: between 0.2 and 0.5 mcg/kg. followed by Intravenous infusion: ranging from 0.2 to 0.7 mcg/kg/h to the discretion of the attending anesthesiologist. Bolus will be initiated prior to surgical incision and infusion will be stopped at wound closure.
Experimental: Intraoperative intravenous lidocaine	Drug: lidocaine; Intravenous bolus: between 0.5 and 1.5 mg/kg. followed by Intravenous infusion: ranging from 0.5 to 2.0 mg/kg/h to the discretion of the attending anesthesiologist. Bolus will be initiated prior to surgical incision and infusion will be stopped at wound closure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	Number of patients who are approached to participate by the study team and who consent to participate in the study.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants receiving dexmedetomidine	Proportion of patients in the dexmedetomidine group who receive per protocol treatment (i.e. they receive dexmedetomidine during general anesthesia).	24 hours
Proportion of participants receiving lidocaine	Proportion of patients in the lidocaine group who receive per protocol treatment (i.e. they receive lidocaine during general anesthesia).	24 hours
Completeness of data collection for outcome measures	Completeness of data collection, defined as the percentage of instruments or data fields completed with at least 90% of expected forms or relevant fields completed at each time point for each instrument and participant.	6 months
Sex representativeness of participants	Proportion of female participants enrolled in the trial.	6 months

Collaborators and Investigators

• Sponsor: CHU de Quebec-Universite Laval
• Collaborators: Canadian Institutes of Health Research (CIHR); International Anesthesia Research Society (IARS); Canadian Perioperative Anesthesia Clinical Trials (PACT) Group
• Investigators: Principal Investigator: Alexis Turgeon, MD MSc FRCPC, CHU de Quebec-Université Laval Research Center; Principal Investigator: Michael Verret, MD PhD FRCPC, CHU de Quebec-Université Laval Research Center; Principal Investigator: Dean A. Fergusson, PhD, Ottawa Hospital Research Institute; Principal Investigator: Manoj M. Lalu, MD PhD FRCPC, Ottawa Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: March 13, 2025
• First Submitted That Met QC Criteria: March 13, 2025
• First Posted (Actual): March 19, 2025

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 25, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Anesthesia; Lidocaine; Postoperative pain; Pilot trial; Quality of recovery; Opioid minimization strategies; Patient-centred outcomes
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Azoles; Imidazoles; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Lidocaine; Dexmedetomidine; Control Groups
• Other Study ID Numbers: OMS-162

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No