Intraoperative Lidocaine Infusion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IV Lidocaine infusion, IV normal saline.
- Who it may be relevant to
- Registry conditions: Enhanced Recovery After Anesthesia. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Intravenous Lidocaine Infusion on Postoperative Inflammatory Response in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Double Blind Controlled Clinical Trial
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.
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.
Interventions
- Drug IV Lidocaine infusion
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 - Drug IV normal saline
IV normal saline 0.9% , rate 50 ml/h
Primary outcome measures
- Postoperative CRP level [Time frame: postoperative day 1 (24 hours postoperative)]
Secondary outcome measures (4)
- Pain scores (VNS) [Time frame: 2, 6, 12, 24 hours]
- GIT motility [Time frame: within 24 hours]
- Postoperative complications [Time frame: within 48 hours]
- Time to ambulation [Time frame: within 48 hours]
Eligibility criteria
Inclusion criteria
- Patients aged 18 - 60 years
- Elective laparoscopic cholecystectomy for symptomatic cholelithiasis or chronic cholecystitis
- ASA physical status I-II
- BMI < 35 kg/m2
- Preoperative CRP <20 mg/L
- Informed consent provided
Exclusion criteria
- Acute cholecystitis or biliary pancreatitis
- Conversion to open surgery
- Pre-op CRP >20 mg/L
- Allergy to lidocaine or local anesthetics
- Known hepatic or renal dysfunction
- Chronic inflammatory conditions
- Current immunosuppressive therapy
- Cardiac arrhythmias or heart block without pacemaker
- ASA physical status III, IV or above
- Pregnancy or breastfeeding
- Psychiatric disorders
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Assiut university main hospital — Asyut
Identifiers
NCT: NCT07150481 · Afaf Radi