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

NCT ID: NCT01717222

Last Updated: 2012-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-10-31

Brief Summary

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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

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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.

Conditions

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Pain, Postoperative Analgesic Requirement Stress Response Return of Bowel Activity Inadequate or Impaired Respiratory Function

Keywords

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Lignocaine Laparoscopic cholecystectomy Pain relief

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Intraperitoneal Lignocaine

Intervention Type DRUG

Patients will receive 100 ml of 0.2% lignocaine

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.

Group Type ACTIVE_COMPARATOR

Intravenous Lignocaine

Intervention Type DRUG

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

Interventions

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Intraperitoneal Lignocaine

Patients will receive 100 ml of 0.2% lignocaine

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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IP Lignocaine IV lignocaine

Eligibility Criteria

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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).
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jawaharlal Institute of Postgraduate Medical Education & Research

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr.D.Ram

Junior Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr. Sarath Chandra Sistla, M.S.,

Role: STUDY_CHAIR

Jawaharlal Institute of Postgraduate Medical Education & Research

Locations

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Department of Surgery, JIPMER

Puducherry, Puducherry, India

Site Status

Countries

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India

References

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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.

Reference Type BACKGROUND
PMID: 16121879 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov

Pubmed site

Other Identifiers

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SEC/2011/4/109

Identifier Type: -

Identifier Source: org_study_id