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Clinical Trials/NCT06837519
NCT06837519CompletedNot Applicable

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

Ain Shams University1 site in 1 country75 target enrollmentStarted: February 20, 2025Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
75
Locations
1
Primary Endpoint
Total morphine consumption

Study Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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/m
  • •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.

Arms & Interventions

Dexmedetomidine group

Experimental

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.

Intervention: Dexmedetomidine (Drug)

Lidocaine group

Experimental

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

Intervention: Lidocaine (Drug)

Lidocaine and Dexmedetomidine group

Experimental

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.

Intervention: Lidocaine and Dexmedetomidine (Drug)

Outcomes

Primary Outcomes

Total morphine consumption

Time Frame: 24 hours postoperatively

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.

Secondary Outcomes

  • Time of extubation(24 hours postoperatively)
  • Time to the first request for the rescue analgesia(24 hours postoperatively)
  • Degree of pain(24 hours postoperatively)
  • Degree of patient satisfaction(24 hours postoperatively)
  • Incidence of adverse events(24 hours postoperatively)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sarah Ahmed

Lecturer of Anesthesia, Intensive care, and pain management, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

Ain Shams University

Study Sites (1)

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