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

C

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Status and phase

Unknown
Phase 4

Conditions

Postoperative Pain

Treatments

Drug: Intravenous lidocaine injection
Drug: Intravenous normal saline injection
Drug: Intraperitoneal lidocaine irrigation group

Study type

Interventional

Funder types

Other

Identifiers

NCT01608373
ChungAngUH4

Details and patient eligibility

About

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.

Enrollment

83 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Laparoscopic cholecystectomy

Exclusion criteria

  • mental change
  • allergy to local anesthetics

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

83 participants in 3 patient groups, including a placebo group

Intravenous lidocaine injection group
Active Comparator group
Description:
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.
Treatment:
Drug: Intravenous lidocaine injection
Intraperitoneal lidocaine irrigation group
Active Comparator group
Description:
Patients in Group P(intraperitoneal lidocaine irrigation group) receive a peritoneal lidocaine irrigation with 3.5mg/kg lidocaine and normal saline 100cc.
Treatment:
Drug: Intraperitoneal lidocaine irrigation group
Intravenous normal saline group
Placebo Comparator group
Description:
The patients in Group C (placebo control group) received normal saline intravenous injection
Treatment:
Drug: Intravenous normal saline injection

Trial contacts and locations

1

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Central trial contact

Hyun Kang, Ph.D

Data sourced from clinicaltrials.gov

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