Intraoperative Lidocaine Infusion

Not Applicable

Not yet recruiting

• Conditions: Enhanced Recovery After Anesthesia
• Interventions: Drug: IV Lidocaine infusion; Drug: IV normal saline

• Registration Number: NCT07150481
• Lead Sponsor: Assiut University

Brief Summary

This study aims to evaluate the analgesic and anti-inflammatory effect of perioperative intravenous lidocaine infusion and in turn the return of gastric motility in patients undergoing elective laparoscopic cholecystectomy.

Detailed Description

Laparoscopic cholecystectomy is considered a minimally invasive procedure; however, it still provokes a measurable systemic inflammatory response. This reaction is primarily driven by factors such as tissue manipulation, peritoneal insufflation, and surgical stress. C-reactive protein (CRP), a widely validated acute-phase reactant, serves as a reliable biomarker to monitor postoperative inflammation, typically peaking within 24 to 48 hours following surgery. Other inflammatory markers such as white blood cell (WBC) count, neutrophil-to-lymphocyte ratio (NLR), and interleukin-6 (IL-6) also exhibit perioperative changes, reflecting the underlying cytokine-mediated stress response. Monitoring these biomarkers provides insight into the extent of tissue injury and can help predict postoperative recovery or complications. Therefore, modulating the inflammatory response-such as through intravenous lidocaine infusion-may improve postoperative outcomes, including pain control, gastrointestinal recovery, and length of hospital stay.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-25
• Study First Submitted QC: 2025-08-25
• Last Update Submitted: 2025-08-25
• Study First Posted: 2025-09-02
• Last Update Posted: 2025-09-02
• Study Start: 2025-10-01
• Primary Completion: 2026-12
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Patients aged 18 - 60 years
2. Elective laparoscopic cholecystectomy for symptomatic cholelithiasis or chronic cholecystitis
3. ASA physical status I-II
4. BMI < 35 kg/m2
5. Preoperative CRP <20 mg/L
6. Informed consent provided

Exclusion Criteria

1. Acute cholecystitis or biliary pancreatitis
2. Conversion to open surgery
3. Pre-op CRP >20 mg/L
4. Allergy to lidocaine or local anesthetics
5. Known hepatic or renal dysfunction
6. Chronic inflammatory conditions
7. Current immunosuppressive therapy
8. Cardiac arrhythmias or heart block without pacemaker
9. ASA physical status III, IV or above
10. Pregnancy or breastfeeding
11. Psychiatric disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group L	IV Lidocaine infusion	IV Lidocaine infusion:
Group C	IV normal saline	IV normal saline

Primary Outcome Measures

Name	Time	Method
Postoperative CRP level	postoperative day 1 (24 hours postoperative)	measurement of Postoperative CRP level

Secondary Outcome Measures

Name	Time	Method
Pain scores (VNS)	2, 6, 12, 24 hours	verbal numerical scale from 0-10. (0 = no pain, 10 = worst imaginable pain The patient verbally reports the number that best reflects their pain intensity.
GIT motility	within 24 hours	Time to first pass of faeces or flatus/bowel movement
Postoperative complications	within 48 hours	nausea, vomiting, ileus, infection
Time to ambulation	within 48 hours	time of patient discharge from the hospital

Trial Locations

Locations (1)

Assiut university main hospital; 🇪🇬 Asyut, Assiut Governorate, Egypt,, Egypt