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

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Intravenous normal saline injection; Drug: Intravenous lidocaine injection; Drug: Intraperitoneal lidocaine irrigation group

• Study Type: Interventional
• Enrollment (Anticipated): 83
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Hyun Kang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Laparoscopic cholecystectomy

Exclusion Criteria:

• mental change
• allergy to local anesthetics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale 4hour	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 4hour.	Post op 4 hour
Visual analogue scale 8hour	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 8hour.	Post op 8 hour
Visual analogue scale 12 hour	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 12hour.	Post op 12hour
visual analogue scale 24hour	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 24hour.	Post op 24hour
Visual analogue scale 48 hour	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 48hour.	Post op 48hour
Opioid consumption 2hour	The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid fom immediately after operation to post op 2hour will be measured.	Post op 2 hour
Opioid consumption 4 hour	The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid fom immediately after operation to post op 4hour will be measured.	Post op 4 hour
Opioid consumption 8 hour	The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid fom immediately after operation to post op 8hour will be measured.	Post op 8 hour
Opioid consumption 12 hout	The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid fom immediately after operation to post op 12hour will be measured.	Post op 12 hour
Opioid consumption 24 hour	The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid fom immediately after operation to post op 24hour will be measured.	Post op 24 hour
Opioid consumption 48hour	The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid fom immediately after operation to post op 48hour will be measured.	Post op 48 hour
FPB 2 hour	The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And total frequency of patient to push the button of the PCA machine (FPB) fom immediately after operation to post op 2 hour will be measured.	Post op 2 hour
FPB 4 hour	The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And total frequency of patient to push the button of the PCA machine (FPB) fom immediately after operation to post op 4 hour will be measured.	Post op 4 hour
FPB 8 hour	The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And total frequency of patient to push the button of the PCA machine (FPB) fom immediately after operation to post op 8 hour will be measured.	Post op 8 hour
FPB 12 hour	The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And total frequency of patient to push the button of the PCA machine (FPB) fom immediately after operation to post op 12 hour will be measured.	Post op 12 hour
FPB 24 hour	The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And total frequency of patient to push the button of the PCA machine (FPB) fom immediately after operation to post op 24 hour will be measured.	Post op 24hour
FPB 48 hour	The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And total frequency of patient to push the button of the PCA machine (FPB) fom immediately after operation to post op 48 hour will be measured.	Post op 48 hour

Collaborators and Investigators

• Sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Anticipated): July 1, 2014
• Study Completion (Anticipated): July 1, 2014

Study Registration Dates

• First Submitted: May 26, 2012
• First Submitted That Met QC Criteria: May 30, 2012
• First Posted (Estimate): May 31, 2012

Study Record Updates

• Last Update Posted (Estimate): August 2, 2013
• Last Update Submitted That Met QC Criteria: August 1, 2013
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Pain; Lidocaine; Intravenous; Laparoscopic cholecystectomy; Intraperitoneum
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: ChungAngUH4