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

Not Applicable

Recruiting

• Conditions: Lidocaine; Dexmedetomidine; Infusion; Perioperative Pain; Video-Assisted Thoracoscopic Surgery
• Interventions: Drug: Lidocaine; Drug: Dexmedetomidine; Drug: Lidocaine and Dexmedetomidine

• Registration Number: NCT06837519
• Lead Sponsor: Ain Shams University

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 Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-15
• Study First Submitted QC: 2025-02-15
• Study Start: 2025-02-20
• Study First Posted: 2025-02-20
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-21
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine group	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
Dexmedetomidine group	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.
Lidocaine and Dexmedetomidine group	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.

Primary Outcome Measures

Name	Time	Method
Total morphine consumption	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 Outcome Measures

Name	Time	Method
Time of extubation	24 hours postoperatively	Time from the end of surgery till extubation
Time to the first request for the rescue analgesia	24 hours postoperatively	Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administrated).
Degree of pain	24 hours postoperatively	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.
Degree of patient satisfaction	24 hours postoperatively	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).
Incidence of adverse events	24 hours postoperatively	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.

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt