Clinical trial NCT01608373: The Effect of Intravenous Lidocaine and Intraperitoneal Lidocaine Irrigation on Pain After Laparoscopic Cholecystectomy
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: Pain
Lidocaine
Intravenous
Intraperitoneum
Laparoscopic cholecystectomy
Lead sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Sponsor class: OTHER
First posted: 2012-05-31
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Laparoscopic cholecystectomy

Exclusion Criteria:

* mental change
* allergy to local anesthetics

Primary outcomes:
measure: Postoperative pain measuring using Visual analogue scale at postoperative 2hour
timeFrame: Post op 2 hour
Secondary outcomes:
measure: Visual analogue scale 4hour
timeFrame: Post op 4 hour
measure: Visual analogue scale 8hour
timeFrame: Post op 8 hour
measure: Visual analogue scale 12 hour
timeFrame: Post op 12hour
measure: visual analogue scale 24hour
timeFrame: Post op 24hour
measure: Visual analogue scale 48 hour
timeFrame: Post op 48hour
measure: Opioid consumption 2hour
timeFrame: Post op 2 hour
measure: Opioid consumption 4 hour
timeFrame: Post op 4 hour
measure: Opioid consumption 8 hour
timeFrame: Post op 8 hour
measure: Opioid consumption 12 hout
timeFrame: Post op 12 hour
measure: Opioid consumption 24 hour
timeFrame: Post op 24 hour
measure: Opioid consumption 48hour
timeFrame: Post op 48 hour
measure: FPB 2 hour
timeFrame: Post op 2 hour
measure: FPB 4 hour
timeFrame: Post op 4 hour
measure: FPB 8 hour
timeFrame: Post op 8 hour
measure: FPB 12 hour
timeFrame: Post op 12 hour
measure: FPB 24 hour
timeFrame: Post op 24hour
measure: FPB 48 hour
timeFrame: Post op 48 hour
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hyun Kang
Study officials:
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Hyun Kang, Ph.D
role: STUDY_CHAIR
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Eun Jin Ahn
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.