Lidocaine and Dexmedetomidine Infusion and Their Combination on Perioperative Pain in Patients Undergoing Video-Assisted Thoracoscopic Surgery

A Randomized Double-Blind Trial Comparing Lidocaine and Dexmedetomidine Infusion and Their Combination on Perioperative Pain in Patients Undergoing Video-Assisted Thoracoscopic Surgery

This study aims to compare lidocaine and dexmedetomidine infusion and their combination on perioperative pain in patients undergoing video-assisted thoracoscopic surgery.

Study Overview

• Status: Recruiting
• Conditions: Dexmedetomidine; Perioperative Pain; Lidocaine; Infusion; Video-Assisted Thoracoscopic Surgery
• Intervention / Treatment: Drug: Lidocaine; Drug: Dexmedetomidine; Drug: Lidocaine and Dexmedetomidine

Detailed Description

Video-assisted thoracoscopic surgery (VATS) is a minimally invasive procedure allowing the reduction of surgical stress. However, postoperative pain management is crucial for patients undergoing VATS, as inadequate pain control can lead to complications (such as lung atelectasis), prolonged recovery, and decreased patient satisfaction.

Dexmedetomidine has shown positive effects on postoperative pain intensity, opioid consumption and other recovery parameters, such as postoperative nausea and vomiting (PONV), and speed of recovery.

Lidocaine has exhibited an excellent safety profile when administered as a low-dose infusion for cancer or non-cancer chronic pain.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah A Afifi, MD; Phone Number: 0501035864; Email: Sarah606060@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Recruiting
    • Ain Shams University
    • Contact: Sarah A Afifi, MD; Phone Number: 0501035864; Email: Sarah606060@gmail.com
    • Principal Investigator: Sondos Afifi, MD
    • Principal Investigator: Ahmed M Eldemerdash, MD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age ≥18 years old.
• Both sexes.
• American Society of Anesthesiologists (ASA) physical status of I, II.
• Patients undergoing video-assisted thoracoscopic surgery (VATS) under general anesthesia.

Exclusion Criteria:

• Hypersensitivity to any of the used drugs.
• Coagulation disorder.
• Body mass index >35 kg/m2.
• History of chronic pain requiring daily opioids/steroids/clonidine/other α2 agonist/analgesics or any drugs acting on the central nervous system during the previous 2 weeks, and drug/alcohol abuse.
• Contraindication to the use of local anesthetics.
• Cardiovascular disease.
• Severe respiratory, renal or hepatic impairment.
• Insulin-dependent diabetes mellitus.
• Central nervous system or psychiatric disease.

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
Experimental: Lidocaine group; Patients will receive lidocaine 0.3 mg/kg over 10 min loading, 0.3 mg/kg/h infusion after induction of anesthesia as maintenance dose till 10 min before the end of the operation plus saline 0.9% with same rate of dexmedetomidine	Drug: Lidocaine; Patients will receive lidocaine 0.3 mg/kg over 10 min loading, 0.3 mg/kg/h infusion after induction of anesthesia as maintenance dose till 10 min before the end of the operation plus saline 0.9% with same rate of dexmedetomidine.
Experimental: Dexmedetomidine group; Patients will receive dexmedetomidine 0.5 μg/kg infusion over 10 min as a loading dose then 0.5 μg/kg/h after induction of anesthesia as maintenance dose till 10 min before the end of the operation plus saline 0.9% with same rate of lidocaine.	Drug: Dexmedetomidine; Patients will receive dexmedetomidine 0.5 μg/kg infusion over 10 min as a loading dose then 0.5 μg/kg/h after induction of anesthesia as maintenance dose till 10 min before the end of the operation plus saline 0.9% with same rate of lidocaine.
Experimental: Lidocaine and Dexmedetomidine group; Patients will receive lidocaine (0.3 mg/kg in 10 min loading, 0.3 mg/kg/h infusion) and dexmedetomidine infusions (0.5 μg/kg infusion over 10 min as a loading dose then 0.5 μg/kg/h) till 10 min before the end of the operation.	Drug: Lidocaine and Dexmedetomidine; Patients will receive lidocaine (0.3 mg/kg in 10 min loading, 0.3 mg/kg/h infusion) and dexmedetomidine infusions (0.5 μg/kg infusion over 10 min as a loading dose then 0.5 μg/kg/h) till 10 min before the end of the operation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total morphine consumption	Rescue analgesia of morphine will be given as 3 mg bolus if the Visual Analogue Scale (VAS)> 3 to be repeated after 30 min if pain persists until the VAS < 4.	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of patient satisfaction	The degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied).	24 hours postoperatively
Time to the first request for the rescue analgesia	Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administrated).	24 hours postoperatively
Time of extubation	Time from the end of surgery till extubation	24 hours postoperatively
Degree of pain	Each patient will be instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be assessed at 0, 4, 8, 12, 18 and 24h postoperatively.	24 hours postoperatively
Incidence of adverse events	Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, pruritis, respiratory depression, lidocaine toxicity (such as lightheadedness, somnolence, perioral numbness, dry mouth, metallic taste, dysarthria or fits) or any other complication will be recorded.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2025
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: February 15, 2025
• First Submitted That Met QC Criteria: February 15, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Hypnotics and Sedatives; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Lidocaine; Dexmedetomidine
• Other Study ID Numbers: FMASU R22/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No