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

Primary Purpose

Pain, Postoperative, Analgesic Requirement, Stress Response

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Intraperitoneal Lignocaine
Intravenous Lignocaine
Sponsored by
Jawaharlal Institute of Postgraduate Medical Education & Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Lignocaine, Laparoscopic cholecystectomy, Pain relief

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Department of Surgery, JIPMER

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intraperitoneal (IP) group

Intravenous (IV) group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Post operative pain relief
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
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
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
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
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

Full Information

First Posted
October 24, 2012
Last Updated
October 29, 2012
Sponsor
Jawaharlal Institute of Postgraduate Medical Education & Research
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1. Study Identification

Unique Protocol Identification Number
NCT01717222
Brief Title
Effect of Intraperitoneal and Intravenous Lignocaine on Pain Relief Following Laparoscopic Cholecystectomy
Official Title
Effect of Intraperitoneal and Intravenous Lignocaine on Pain Relief Following Laparoscopic Cholecystectomy - A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jawaharlal Institute of Postgraduate Medical Education & Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Analgesic Requirement, Stress Response, Return of Bowel Activity, Inadequate or Impaired Respiratory Function
Keywords
Lignocaine, Laparoscopic cholecystectomy, Pain relief

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intraperitoneal (IP) group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Intravenous (IV) group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Intraperitoneal Lignocaine
Other Intervention Name(s)
IP Lignocaine
Intervention Description
Patients will receive 100 ml of 0.2% lignocaine
Intervention Type
Drug
Intervention Name(s)
Intravenous Lignocaine
Other Intervention Name(s)
IV lignocaine
Intervention Description
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
Primary Outcome Measure Information:
Title
Post operative pain relief
Description
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.
Time Frame
1 hour postoperatively
Secondary Outcome Measure Information:
Title
Postoperative Analgesic Requirement
Description
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.
Time Frame
First 24 hours in the postoperative period
Title
Postoperative pain relief
Description
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
Time Frame
8 hours postoperatively
Title
Postoperative pain relief
Description
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
Time Frame
24 hours postoperatively
Title
Postoperative pain relief
Description
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
Time Frame
48 hours postoperatively
Other Pre-specified Outcome Measures:
Title
Stress response in the form of Total Leucocyte Count (TLC) and C- reactive protein (CRP)
Description
Blood will be analyzed for TLC and CRP preoperatively and 48 hours postoperatively to assess the stress response
Time Frame
Preoperatively and 48 hours Postoperatively
Title
Respiratory Function
Description
Respiratory function will be assessed by measuring the peak expiratory flow rate (PEFR)at the above mentioned time frames.
Time Frame
Preoperatively and 48 hours Postoperatively
Title
Return of bowel activity
Description
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.
Time Frame
upto to 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Sarath Chandra Sistla, M.S.,
Organizational Affiliation
Jawaharlal Institute of Postgraduate Medical Education & Research
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Surgery, JIPMER
City
Pondicherry
ZIP/Postal Code
605006
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
16121879
Citation
Jabbour-Khoury SI, Dabbous AS, Gerges FJ, Azar MS, Ayoub CM, Khoury GS. Intraperitoneal and intravenous routes for pain relief in laparoscopic cholecystectomy. JSLS. 2005 Jul-Sep;9(3):316-21.
Results Reference
background
Links:
URL
http://www.ncbi.nlm.nih.gov
Description
Pubmed site

Learn more about this trial

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

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