Intraoperative Lidocaine Infusion (IV)

Assiut University

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Enhanced Recovery After Anesthesia

Treatments: Drug: IV normal saline; Drug: IV Lidocaine infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT07150481

Afaf Radi

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups, including a placebo group

Group L

Active Comparator group

Description:

IV Lidocaine infusion:

Treatment:

Drug: IV Lidocaine infusion

Group C

Placebo Comparator group

Description:

IV normal saline

Treatment:

Drug: IV normal saline