Lidocaine + Dexmedetomidine for Surgery Outcomes

(OPUS Trial)

Overseen By Sophie Guay, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: CHU de Quebec-Universite Laval

Must not be taking: Alpha-2 agonists, Local anesthetics

Disqualifiers: Pregnancy, Severe renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 hours

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you regularly use alpha-2 agonists or local anesthetics, you may not be eligible to participate.

What data supports the effectiveness of the drug combination of Lidocaine and Dexmedetomidine for surgery outcomes?

Research shows that dexmedetomidine can enhance the pain-relieving effects of lidocaine, making it more effective in blocking pain during procedures. Additionally, dexmedetomidine has been found to improve the duration and quality of pain relief when used with other local anesthetics, suggesting it could be beneficial in surgical settings. ^{1 2 3 4 5}

Is the combination of Lidocaine and Dexmedetomidine safe for use in surgeries?

Dexmedetomidine has been studied for its safety in various surgeries and is generally well-tolerated, with some reports of low blood pressure and slow heart rate. It is known to reduce the need for other anesthetics and improve recovery without serious side effects. However, specific safety data for the combination with Lidocaine is not provided in the available research. ^{2 6 7 8 9}

How is the drug combination of lidocaine and dexmedetomidine unique for surgery outcomes?

The combination of lidocaine and dexmedetomidine is unique because it not only enhances the local anesthetic effect of lidocaine but also reduces inflammation during surgery, potentially improving recovery compared to using either drug alone. ^{3 8 10 11 12}

What is the purpose of this 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.

Research Team

Manoj M. Lalu, MD PhD FRCPC

Principal Investigator

Ottawa Hospital Research Institute

Dean A. Fergusson, PhD

Principal Investigator

Ottawa Hospital Research Institute

Michael Verret, MD PhD FRCPC

Principal Investigator

CHU de Quebec-Université Laval Research Center

Alexis Turgeon, MD MSc FRCPC

Principal Investigator

CHU de Quebec-Université Laval Research Center

Eligibility Criteria

This trial is for patients undergoing major non-cardiac surgery who may benefit from improved recovery strategies. It aims to test if dexmedetomidine and lidocaine given during general anesthesia can help with postoperative pain and quality of life. Specific eligibility criteria are not provided, but typically include adults in good health without conditions that would interfere with the study or pose risks.

Inclusion Criteria

Able to complete baseline quality of recovery assessment

I will need general anesthesia for my procedure.

I am scheduled for a major surgery that is not heart-related, lasting over 1.5 hours and requires at least one night in the hospital.

Exclusion Criteria

Pregnant women

No fixed address

I am not allergic to dexmedetomidine or lidocaine and do not have severe kidney, liver issues, slow heart rate, or low blood pressure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive intraoperative intravenous dexmedetomidine or lidocaine during major non-cardiac surgery

24 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Dexmedetomidine
• Lidocaine

Trial Overview The OPUS Anesthesia Pilot Trial is testing whether intravenous dexmedetomidine and lidocaine administered during surgery can improve patient outcomes compared to a control group receiving standard care. The study will assess the feasibility of a larger phase 3 trial on these interventions.

Participant Groups

Group I: Usual care Experimental Treatment 1 Intervention

Group II: Intraoperative intravenous lidocaine Experimental Treatment 1 Intervention

Group III: Intraoperative intravenous dexmedetomidine Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

CHU de Quebec-Universite Laval

Lead Sponsor

Trials

177

Recruited

110,000+

Canadian Perioperative Anesthesia Clinical Trials (PACT) Group

Collaborator

Trials

2

Recruited

840+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

International Anesthesia Research Society (IARS)

Collaborator

Trials

7

Recruited

1,700+

References

1. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Effect of dexmedetomidine added to spinal bupivacaine for urological procedures. [2022]

2. France pubmed.ncbi.nlm.nih.gov

A dose-response study of caudal dexmedetomidine with ropivacaine in pediatric day care patients undergoing lower abdominal and perineal surgeries: a randomized controlled trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Dexmedetomidine Dose Dependently Enhances the Local Anesthetic Action of Lidocaine in Inferior Alveolar Nerve Block: A Randomized Double-Blind Study. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Effects of Systemic Lidocaine Versus Dexmedetomidine on the Recovery Quality and Analgesia After Thyroid Cancer Surgery: A Randomized Controlled Trial. [2023]

5. India pubmed.ncbi.nlm.nih.gov

Comparison of Local Wound Infiltration with Ropivacaine Alone or Ropivacaine Plus Dexmedetomidine for Postoperative Pain Relief after Lower Segment Cesarean Section. [2022]

6. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Dexmedetomidine as a part of analgesic component of general anesthesia for laparoscopic operations]. [2015]

7. England pubmed.ncbi.nlm.nih.gov

Dexmedetomidine and cardiac protection for non-cardiac surgery: a meta-analysis of randomised controlled trials. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Dexmedetomidine: review, update, and future considerations of paediatric perioperative and periprocedural applications and limitations. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Dexmedetomidine, an alpha 2-adrenoceptor agonist, reduces anesthetic requirements for patients undergoing minor gynecologic surgery. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Effects of intravenous lidocaine, dexmedetomidine, and their combination on IL-1, IL-6 and TNF-α in patients undergoing laparoscopic hysterectomy: a prospective, randomized controlled trial. [2021]

11. Poland pubmed.ncbi.nlm.nih.gov

A COMPARATIVE STUDY OF TWO DIFFERENT DOSES OF DEXMEDETOMIDINE AS ADJUNCT TO LIDOCAINE IN INTRAVENOUS REGIONAL ANESTHESIA. [2022]

12. India pubmed.ncbi.nlm.nih.gov

Dexmedetomidine decreases the requirement of ketamine and propofol during burns debridement and dressings. [2022]