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
1 other identifier
interventional
83
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 postoperative-pain
Started Jul 2011
Longer than P75 for phase_4 postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 26, 2012
CompletedFirst Posted
Study publicly available on registry
May 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedAugust 2, 2013
July 1, 2011
3 years
May 26, 2012
August 1, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative pain measuring using Visual analogue scale at postoperative 2hour
Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. To check the severity of pain VAS will be measured at post op 2hour.
Post op 2 hour
Secondary Outcomes (17)
Visual analogue scale 4hour
Post op 4 hour
Visual analogue scale 8hour
Post op 8 hour
Visual analogue scale 12 hour
Post op 12hour
visual analogue scale 24hour
Post op 24hour
Visual analogue scale 48 hour
Post op 48hour
- +12 more secondary outcomes
Study Arms (3)
Intravenous lidocaine injection group
ACTIVE COMPARATORPatients 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.
Intraperitoneal lidocaine irrigation group
ACTIVE COMPARATORPatients in Group P(intraperitoneal lidocaine irrigation group) receive a peritoneal lidocaine irrigation with 3.5mg/kg lidocaine and normal saline 100cc.
Intravenous normal saline group
PLACEBO COMPARATORThe patients in Group C (placebo control group) received normal saline intravenous injection
Interventions
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
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.
The patients in Group C (placebo control group) received normal saline intravenous injection
Eligibility Criteria
You may qualify if:
- Laparoscopic cholecystectomy
You may not qualify if:
- mental change
- allergy to local anesthetics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hyun Kang
Seoul, South Korea
Related Publications (1)
Yang SY, Kang H, Choi GJ, Shin HY, Baek CW, Jung YH, Choi YS. Efficacy of intraperitoneal and intravenous lidocaine on pain relief after laparoscopic cholecystectomy. J Int Med Res. 2014 Apr;42(2):307-19. doi: 10.1177/0300060513505493.
PMID: 24648482DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hyun Kang, Ph.D
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
- PRINCIPAL INVESTIGATOR
Eun Jin Ahn
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
May 26, 2012
First Posted
May 31, 2012
Study Start
July 1, 2011
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
August 2, 2013
Record last verified: 2011-07