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

NCT01717222 | Completed Phase 4 DMC

• 1 other identifier: SEC/2011/4/109
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Lignocaine; Laparoscopic cholecystectomy; Pain relief

Outcome Measures

Primary Outcomes (1)

• 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.

  1 hour postoperatively

Secondary Outcomes (4)

• Postoperative Analgesic Requirement

  First 24 hours in the postoperative period

• Postoperative pain relief

  8 hours postoperatively

• Postoperative pain relief

  24 hours postoperatively

• Postoperative pain relief

  48 hours postoperatively

Other Outcomes (3)

• Stress response in the form of Total Leucocyte Count (TLC) and C- reactive protein (CRP)

  Preoperatively and 48 hours Postoperatively

• Respiratory Function

  Preoperatively and 48 hours Postoperatively

• Return of bowel activity

  upto to 48 hours

Study Arms (2)

Intraperitoneal (IP) group

ACTIVE COMPARATOR

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

Intravenous (IV) group

ACTIVE COMPARATOR

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

Interventions

Intraperitoneal Lignocaine DRUG

Patients will receive 100 ml of 0.2% lignocaine

Also known as: IP Lignocaine

Intraperitoneal (IP) group

Intravenous Lignocaine 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

Also known as: IV lignocaine

Intravenous (IV) group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Jawaharlal Institute of Postgraduate Medical Education & Research: lead

Study Sites (1)

Department of Surgery, JIPMER

Puducherry, Puducherry, 605006, India

Location

Related Publications (1)

• 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.

  PMID: 16121879 BACKGROUND

Related Links

• Pubmed site

MeSH Terms

Conditions

Pain, Postoperative; Fractures, Stress; Respiratory Insufficiency

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Fractures, Bone; Wounds and Injuries; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Dr. Sarath Chandra Sistla, M.S.,

  Jawaharlal Institute of Postgraduate Medical Education & Research

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Resident

Study Record Dates

• First Submitted: October 24, 2012
• First Posted: October 30, 2012
• Study Start: December 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 30, 2012

Record last verified: 2012-10

Locations

IN (1)