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Comparison of Lidocaine and Saline for Pain Relief After Gallbladder Surgery

Evaluation of the effect of the intravenous lidocaine bolus dose during surgery on postoperative pain in patients undergoing laparoscopic cholecystectomy under general anesthesia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241214064051N3
Enrollment
88
Registered
2025-05-04
Start date
2025-05-05
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain Management in Patients Undergoing Elective Laparoscopic Cholecystectomy. Other acute postprocedural pain

Interventions

Intervention 1: Intervention group: Participants in this group will receive an intravenous bolus of lidocaine during surgery. Lidocaine hydrochloride 2% solution (manufactured by Shahid Ghazi, Iran) w

Sponsors

Babol University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult patients aged 18 years or older. Patients scheduled for elective laparoscopic cholecystectomy. Classified as ASA physical status I or II. Ability to provide informed consent. No known contraindications or hypersensitivity to lidocaine.

Exclusion criteria

Exclusion criteria: Known allergy or hypersensitivity to lidocaine or other amide-type local anesthetics Significant hepatic or renal dysfunction. History of severe cardiac arrhythmias or conduction abnormalities. Pregnant or breastfeeding women. Patients undergoing emergency surgery Presence of chronic pain conditions requiring regular opioid treatment. Any contraindication to general anesthesia. Inability to provide valid informed consent.

Design outcomes

Primary

MeasureTime frame
Postoperative pain intensity (VAS score) in patients undergoing laparoscopic cholecystectomy under general anesthesia. Timepoint: 1 hour after recovery from general anesthesia. Method of measurement: Visual Analogue Scale (VAS), 10 cm line from 0 (no pain) to 10 (worst imaginable pain).

Secondary

MeasureTime frame
Incidence of postoperative vomiting within the first 24 hours after surgery. Timepoint: Continuously during the first 24 hours after surgery. Method of measurement: Assessed by direct patient questioning and clinical observation by trained anesthesia staff.;Need for postoperative antiemetic (ondansetron) within the first 24 hours after surgery. Timepoint: Continuously during the first 24 hours after surgery. Method of measurement: Recorded when ondansetron is administered following any episode of postoperative nausea or vomiting.;Total dose of ondansetron administered (mg) during the first 24 hours after surgery. Timepoint: Within the first 24 hours after surgery. Method of measurement: Cumulative dose recorded by anesthesia staff.;Incidence of lidocaine-related adverse effects during and after surgery. Timepoint: From start of lidocaine administration until 48 hours after surgery. Method of measurement: Clinical monitoring and documentation of symptoms such as cardiovascular, neurologic, dermatologic, or gastrointestinal adverse events.;Need for postoperative analgesia (pethidine). Timepoint: During the first 24 hours after surgery. Method of measurement: Based on VAS score = 4; pethidine administered and recorded.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMarjan Khoshnevis

Babol University of Medical Sciences

Marjan66192@gmail.com+98 911 218 2557

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026