Intraoperative Lidocaine Infusion

Phase 3Not Yet RecruitingNCT07150481

Assiut University90 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Enhanced Recovery After Anesthesia

Interventions

IV Lidocaine infusionDRUG

2 mg/kg/h (the total dose of lidocaine per hour will be calculated and add to normal saline 0.9% to total volume 50 ml and infused by a rate 50 ml/h till the end of the procedure

IV normal salineDRUG

IV normal saline 0.9% , rate 50 ml/h

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Assiut university main hospital

Asyut, Assiut Governorate, Egypt,, Egypt

Outcomes

Primary Outcomes

Postoperative CRP level

measurement of Postoperative CRP level

Time frame: postoperative day 1 (24 hours postoperative)

Secondary Outcomes

Pain scores (VNS)

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.

Time frame: 2, 6, 12, 24 hours

GIT motility

Time to first pass of faeces or flatus/bowel movement

Time frame: within 24 hours

Postoperative complications

nausea, vomiting, ileus, infection

Time frame: within 48 hours

Time to ambulation

time of patient discharge from the hospital

Time frame: within 48 hours