Intraoperative Lidocaine Infusion

NCT07150481 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: Afaf Radi
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Enhanced Recovery After Anesthesia

Outcome Measures

Primary Outcomes (1)

• Postoperative CRP level

  measurement of Postoperative CRP level

  postoperative day 1 (24 hours postoperative)

Secondary Outcomes (4)

• Pain scores (VNS)

  2, 6, 12, 24 hours

• GIT motility

  within 24 hours

• Postoperative complications

  within 48 hours

• Time to ambulation

  within 48 hours

Study Arms (2)

Group L

ACTIVE COMPARATOR

IV Lidocaine infusion:

Drug: IV Lidocaine infusion

Group C

PLACEBO COMPARATOR

IV normal saline

Drug: IV normal saline

Interventions

IV Lidocaine infusion DRUG

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

Group L

IV normal saline DRUG

IV normal saline 0.9% , rate 50 ml/h

Group C

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university main hospital

Asyut, Assiut Governorate, Egypt,, 71515, Egypt

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Noha Y Mohamed, MD

  Lecturer in anesthesia and intensive care department, faculty of medicine,

  PRINCIPAL INVESTIGATOR

• Noha Y Mohammed, MD

  Lecturer in anesthesia and intensive care department, faculty of medicine,

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noha Y Mohammed, MD

CONTACT

+201001890194; noha.hagagy@gmail.com

Afaf R Youssef, MBBCH

CONTACT

01207787689; aymansamaan214@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia and intensive care, faculty of medicine, Assiut university.

Model Details: group L: lidocaine IV infusion group C: normal saline 0.9% IV infusion

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 2, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)