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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Chung-Ang University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Hyun Kang, Chung-Ang University Hospital
ClinicalTrials.gov Identifier:
NCT01608373
First received: May 26, 2012
Last updated: August 1, 2013
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Postoperative Pain
Drug: Intravenous lidocaine injection
Drug: Intraperitoneal lidocaine irrigation group
Drug: Intravenous normal saline injection
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Chung-Ang University Hospital:

Primary Outcome Measures:
  • Postoperative pain measuring using Visual analogue scale at postoperative 2hour [ Time Frame: Post op 2 hour ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Visual analogue scale 4hour [ Time Frame: Post op 4 hour ] [ Designated as safety issue: No ]

    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.


  • Visual analogue scale 8hour [ Time Frame: Post op 8 hour ] [ Designated as safety issue: No ]

    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.


  • Visual analogue scale 12 hour [ Time Frame: Post op 12hour ] [ Designated as safety issue: Yes ]

    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.


  • visual analogue scale 24hour [ Time Frame: Post op 24hour ] [ Designated as safety issue: No ]

    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.


  • Visual analogue scale 48 hour [ Time Frame: Post op 48hour ] [ Designated as safety issue: No ]

    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.


  • Opioid consumption 2hour [ Time Frame: Post op 2 hour ] [ Designated as safety issue: No ]
    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.

  • Opioid consumption 4 hour [ Time Frame: Post op 4 hour ] [ Designated as safety issue: No ]
    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.

  • Opioid consumption 8 hour [ Time Frame: Post op 8 hour ] [ Designated as safety issue: No ]
    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.

  • Opioid consumption 12 hout [ Time Frame: Post op 12 hour ] [ Designated as safety issue: No ]
    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.

  • Opioid consumption 24 hour [ Time Frame: Post op 24 hour ] [ Designated as safety issue: No ]
    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.

  • Opioid consumption 48hour [ Time Frame: Post op 48 hour ] [ Designated as safety issue: No ]
    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.

  • FPB 2 hour [ Time Frame: Post op 2 hour ] [ Designated as safety issue: No ]
    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.

  • FPB 4 hour [ Time Frame: Post op 4 hour ] [ Designated as safety issue: No ]
    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.

  • FPB 8 hour [ Time Frame: Post op 8 hour ] [ Designated as safety issue: No ]
    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.

  • FPB 12 hour [ Time Frame: Post op 12 hour ] [ Designated as safety issue: No ]
    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.

  • FPB 24 hour [ Time Frame: Post op 24hour ] [ Designated as safety issue: No ]
    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.

  • FPB 48 hour [ Time Frame: Post op 48 hour ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 83
Study Start Date: July 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: IV normal saline

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Laparoscopic cholecystectomy

Exclusion Criteria:

  • mental change
  • allergy to local anesthetics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01608373

Contacts
Contact: Hyun Kang, Ph.D 82-2-6299-2571 roman00@naver.com

Locations
Korea, Republic of
Hyun Kang Recruiting
Seoul, Korea, Republic of
Contact: SeongDeok Kim, M.D. & Ph.D.    82-2-6299-2571    ksdeok@cau.ac.kr   
Principal Investigator: Hyun Kang, Ph.D.         
Sub-Investigator: Eun Jin Ahn         
Sponsors and Collaborators
Chung-Ang University Hospital
Investigators
Study Chair: Hyun Kang, Ph.D Chungang University Hospital
Principal Investigator: Eun Jin Ahn Chungang University Hospital
  More Information

No publications provided

Responsible Party: Hyun Kang, Assistant professor, Chung-Ang University Hospital
ClinicalTrials.gov Identifier: NCT01608373     History of Changes
Other Study ID Numbers: ChungAngUH4
Study First Received: May 26, 2012
Last Updated: August 1, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Chung-Ang University Hospital:
Pain
Lidocaine
Intravenous
Intraperitoneum
Laparoscopic cholecystectomy

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Lidocaine
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 21, 2014