NCT01608373

The Effect of Intravenous Lidocaine and Intraperitoneal Lidocaine Irrigation on Pain After Laparoscopic Cholecystectomy

Comparison of Intravenous Lidocaine and Intraperitoneal Lidocaine Irrigation for Effective Pain Relief After Laparoscopic Cholecystectomy: A Prospective, Randomized, Double-blind, Placebo-controlled Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 83 (estimated)
• Sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This prospective randomized study aims to comparison the effectiveness of intravenous lidocaine injection and intraperitoneam lidocaine irrigation on the relief of pain in patients undergoing laparoscopic cholecystectomy. A total of 83 patients will be randomized into one of three groups (group C or group I or group P) based on Excel number generation. Patients in group C will receive normal saline intravenous injection, and patients in group I will receive an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr. Patients in group P will receive intraperitoneal lidocaine irrigation with 3.5 mg/kg lidocaine and normal saline 100cc. Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 2, 4, 8, 12, 24, 48 hours postoperatively.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Intravenous lidocaine injection	Patients in Group I (intravenous lidocaine injection group) received an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr
DRUG	Intraperitoneal lidocaine irrigation group	Patients in Group P(intraperitoneal lidocaine irrigation group) receive a peritoneal lidocaine irrigation with 3.5mg/kg lidocaine and normal saline 100cc. 50cc of irrigation fluid will be spread below diaphragm and 50cc of irrigation fluid will be spread around the gall bladder.
DRUG	Intravenous normal saline injection	The patients in Group C (placebo control group) received normal saline intravenous injection

Timeline

• Start date: 2011-07-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2012-05-31
• Last updated: 2013-08-02

Locations

1 site across 1 country: South Korea