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
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.
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 4hourVisual 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
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
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