Intraoperative Lidocaine Infusion

NCT ID: NCT07150481

Last Updated: 2025-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2027-03-31

Brief Summary

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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

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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.

Conditions

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Enhanced Recovery After Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

group L: lidocaine IV infusion group C: normal saline 0.9% IV infusion
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
double blinded

Study Groups

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Group L

IV Lidocaine infusion:

Group Type ACTIVE_COMPARATOR

IV Lidocaine infusion

Intervention Type 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 C

IV normal saline

Group Type PLACEBO_COMPARATOR

IV normal saline

Intervention Type DRUG

IV normal saline 0.9% , rate 50 ml/h

Interventions

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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

Intervention Type DRUG

IV normal saline

IV normal saline 0.9% , rate 50 ml/h

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Noha Yahia Mohammd El-hagagy

Lecturer of anesthesia and intensive care, faculty of medicine, Assiut university.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Noha Y Mohamed, MD

Role: PRINCIPAL_INVESTIGATOR

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

Noha Y Mohammed, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Assiut university main hospital

Asyut, Assiut Governorate, Egypt,, Egypt

Site Status

Countries

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Egypt

Central Contacts

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Noha Y Mohammed, MD

Role: CONTACT

+201001890194

Afaf R Youssef, MBBCH

Role: CONTACT

01207787689 ext. +2

Facility Contacts

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Noha Y Mohammed, MD

Role: primary

01001890194 ext. +2

Afaf R Youssef, MBBCH

Role: backup

01207787689 ext. +2

Other Identifiers

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Afaf Radi

Identifier Type: -

Identifier Source: org_study_id

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