Effect of Intraperitoneal and Intravenous Lignocaine on Pain Relief Following Laparoscopic Cholecystectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr.D.Ram, Jawaharlal Institute of Postgraduate Medical Education & Research
ClinicalTrials.gov Identifier:
NCT01717222
First received: October 24, 2012
Last updated: October 29, 2012
Last verified: October 2012
  Purpose

Laparoscopic Cholecystectomy is the treatment of choice for patients with symptomatic gall stones. For pain relief following laparoscopic cholecystectomy both intraperitoneal and intravenous administration of lignocaine has been used. But it is not clear from the existing literature which form of administration is more effective for pain relief. Hence this study has been undertaken with the following hypothesis : Intravenous lignocaine is superior to intraperitoneal lignocaine for postoperative pain relief and minimizing the stress response in laparoscopic cholecystectomy.


Condition Intervention Phase
Pain, Postoperative
Analgesic Requirement
Stress Response
Return of Bowel Activity
Inadequate or Impaired Respiratory Function
Drug: Intraperitoneal Lignocaine
Drug: Intravenous Lignocaine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Intraperitoneal and Intravenous Lignocaine on Pain Relief Following Laparoscopic Cholecystectomy - A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Jawaharlal Institute of Postgraduate Medical Education & Research:

Primary Outcome Measures:
  • Post operative pain relief [ Time Frame: 1 hour postoperatively ] [ Designated as safety issue: No ]
    Post operative pain relief will be assessed by visual analogue scale with values between 0 and 10. 0 denotes no pain and 10 denotes worst pain. the patient uses this scale to represent his/her pain at 1 hour postoperatively.


Secondary Outcome Measures:
  • Postoperative Analgesic Requirement [ Time Frame: First 24 hours in the postoperative period ] [ Designated as safety issue: No ]
    Patients will get analgesia through patient controlled analgesia pump (PCA). This pump delivers Morphine for pain relief. This will be delivered at 1 mg/ml bolus dose with a lock out period of 15 minutes without any background infusion of the drug. The total requirement over a period of 24 hours will be noted. Also the time taken for the patient to take the first analgesic dose will be recorded. The total demands and the number of good demands in the PCA pump will also be recorded.

  • Postoperative pain relief [ Time Frame: 8 hours postoperatively ] [ Designated as safety issue: No ]
    Post operative pain relief will be assessed by visual analogue scale with values between 0 and 10. 0 denotes no pain and 10 denotes worst pain. the patient uses this scale to represent his/her pain at 8 hours postoperatively

  • Postoperative pain relief [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
    Post operative pain relief will be assessed by visual analogue scale with values between 0 and 10. 0 denotes no pain and 10 denotes worst pain. the patient uses this scale to represent his/her pain at 24 hours postoperatively

  • Postoperative pain relief [ Time Frame: 48 hours postoperatively ] [ Designated as safety issue: No ]
    Post operative pain relief will be assessed by visual analogue scale with values between 0 and 10. 0 denotes no pain and 10 denotes worst pain. the patient uses this scale to represent his/her pain at 48 hours postoperatively


Other Outcome Measures:
  • Stress response in the form of Total Leucocyte Count (TLC) and C- reactive protein (CRP) [ Time Frame: Preoperatively and 48 hours Postoperatively ] [ Designated as safety issue: No ]
    Blood will be analyzed for TLC and CRP preoperatively and 48 hours postoperatively to assess the stress response

  • Respiratory Function [ Time Frame: Preoperatively and 48 hours Postoperatively ] [ Designated as safety issue: No ]
    Respiratory function will be assessed by measuring the peak expiratory flow rate (PEFR)at the above mentioned time frames.

  • Return of bowel activity [ Time Frame: upto to 48 hours ] [ Designated as safety issue: No ]
    This will be assessed by asking the time at which the patient perceives the first bowel movement and also the time for passage of flatus post surgery.


Enrollment: 50
Study Start Date: December 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intraperitoneal (IP) group
Patients will receive 100 ml of 0.2% Lignocaine as intraperitoneal lignocaine irrigation in the gall bladder fossa along with a placebo of normal saline of volume equivalent to 1.5 mg/kg of intravenous lignocaine at induction and normal saline of volume equivalent to 2 mg/kg/hour of intravenous lignocaine as continuous infusion until one hour postoperatively to ensure blinding
Drug: Intraperitoneal Lignocaine
Patients will receive 100 ml of 0.2% lignocaine
Other Name: IP Lignocaine
Active Comparator: Intravenous (IV) group
Patients will receive 1.5mg/kg of intravenous lignocaine as bolus dose at induction and 2mg/kg/hour as continuous infusion of intravenous lignocaine until one hour after surgery and 100 ml of saline intraperitoneally as placebo to ensure blinding.
Drug: Intravenous Lignocaine
Intravenous group patients will receive 1.5mg/kg of lignocaine as bolus dose at induction and 2mg/kg/hour as continuous infusion until one hour after surgery
Other Name: IV lignocaine

Detailed Description:

Laparoscopic Cholecystectomy is the treatment of choice for patients with symptomatic gall stones. For pain relief following laparoscopic cholecystectomy both intraperitoneal and intravenous administration of lignocaine has been used. But it is not clear from the existing literature which form of administration is more effective for pain relief. Hence this study has been undertaken with the following hypothesis : Intravenous lignocaine is superior to intraperitoneal lignocaine for postoperative pain relief and minimizing the stress response in laparoscopic cholecystectomy.

In this study the effect of intraperitoneal and intravenous lignocaine will be assessed based on the postoperative pain scores, total analgesic requirement, stress response in the form of total leukocyte count, c-reactive protein levels,return of bowel activity.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients planned for elective laparoscopic cholecystectomy in the age group of 20 -60 years belonging to American society of anesthesiologists (ASA)score I-II

Exclusion Criteria:

  • Chronic pain diseases other than gall stone disease.
  • Use of opioids, steroids, Non steroidal anti inflammatory drugs or alcohol.
  • Allergy and contraindication to Lignocaine.
  • Conversion to open cholecystectomy.
  • Patients who do not comprehend Visual analogue scale (VAS) / patient controlled analgesia (PCA).
  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: NCT01717222

Locations
India
Department of Surgery, JIPMER
Pondicherry, India, 605006
Sponsors and Collaborators
Jawaharlal Institute of Postgraduate Medical Education & Research
Investigators
Study Chair: Dr. Sarath Chandra Sistla, M.S., Jawaharlal Institute of Postgraduate Medical Education & Research
  More Information

Additional Information:
Publications:
Responsible Party: Dr.D.Ram, Junior Resident, Jawaharlal Institute of Postgraduate Medical Education & Research
ClinicalTrials.gov Identifier: NCT01717222     History of Changes
Other Study ID Numbers: SEC/2011/4/109
Study First Received: October 24, 2012
Last Updated: October 29, 2012
Health Authority: India: Institutional Review Board

Keywords provided by Jawaharlal Institute of Postgraduate Medical Education & Research:
Lignocaine
Laparoscopic cholecystectomy
Pain relief

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

ClinicalTrials.gov processed this record on August 21, 2014