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

Information source: Chung-Ang University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postoperative Pain

Intervention: Intravenous lidocaine injection (Drug); Intraperitoneal lidocaine irrigation group (Drug); Intravenous normal saline injection (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Chung-Ang University Hospital

Official(s) and/or principal investigator(s):
Hyun Kang, Ph.D, Study Chair, Affiliation: Chungang University Hospital
Eun Jin Ahn, Principal Investigator, Affiliation: Chungang University Hospital

Overall contact:
Hyun Kang, Ph.D, Phone: 82-2-6299-2571, Email: roman00@naver.com


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Postoperative pain measuring using Visual analogue scale at postoperative 2hour

Secondary outcome:

Visual analogue scale 4hour

Visual analogue scale 8hour

Visual analogue scale 12 hour

visual analogue scale 24hour

Visual analogue scale 48 hour

Opioid consumption 2hour

Opioid consumption 4 hour

Opioid consumption 8 hour

Opioid consumption 12 hout

Opioid consumption 24 hour

Opioid consumption 48hour

FPB 2 hour

FPB 4 hour

FPB 8 hour

FPB 12 hour

FPB 24 hour

FPB 48 hour


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria:

- Laparoscopic cholecystectomy

Exclusion Criteria:

- mental change

- allergy to local anesthetics

Locations and Contacts

Hyun Kang, Ph.D, Phone: 82-2-6299-2571, Email: roman00@naver.com

Hyun Kang, Seoul, Korea, Republic of; Recruiting
SeongDeok Kim, M.D. & Ph.D., Phone: 82-2-6299-2571, Email: ksdeok@cau.ac.kr
Hyun Kang, Ph.D., Principal Investigator
Eun Jin Ahn, Sub-Investigator
Additional Information

Starting date: July 2011
Last updated: August 1, 2013

Page last updated: August 23, 2015

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