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NCT Number: NCT07150481

Intraoperative Lidocaine Infusion

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

IV normal saline

Drug

IV normal saline 0.9% , rate 50 ml/h

Primary outcomes

  1. Postoperative CRP level

    Time frame: postoperative day 1 (24 hours postoperative)

    measurement of Postoperative CRP level

Secondary outcomes

  1. Pain scores (VNS)

    Time frame: 2, 6, 12, 24 hours

    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.

  2. GIT motility

    Time frame: within 24 hours

    Time to first pass of faeces or flatus/bowel movement

  3. Postoperative complications

    Time frame: within 48 hours

    nausea, vomiting, ileus, infection

  4. Time to ambulation

    Time frame: within 48 hours

    time of patient discharge from the hospital

Study contacts

Contact information is provided by the study sponsor or research team.

Afaf R Youssef, MBBCH

CONTACT

[email protected]

01207787689 ext. +2

Noha Y Mohammed, MD

CONTACT

[email protected]

+201001890194

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Effect of Intravenous Lidocaine Infusion on Postoperative Inflammatory Response in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Double Blind Controlled Clinical Trial

Acronym: IV

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 2, 2025
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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