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

Phase 4

Completed

• Conditions: Pain, Postoperative; Analgesic Requirement; Stress Response; Return of Bowel Activity; Inadequate or Impaired Respiratory Function
• Interventions: Drug: Intraperitoneal Lignocaine; Drug: Intravenous Lignocaine

• Registration Number: NCT01717222
• Lead Sponsor: Jawaharlal Institute of Postgraduate Medical Education & Research

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.

Study Timeline

• Study Start: 2011-12
• Status Verified: 2012-10
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Study First Submitted: 2012-10-24
• Study First Submitted QC: 2012-10-29
• Last Update Submitted: 2012-10-29
• Study First Posted: 2012-10-30
• Last Update Posted: 2012-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intraperitoneal (IP) group	Intraperitoneal Lignocaine	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
Intravenous (IV) group	Intravenous Lignocaine	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.

Primary Outcome Measures

Name	Time	Method
Post operative pain relief	1 hour postoperatively	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

Name	Time	Method
Postoperative pain relief	48 hours postoperatively	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
Postoperative Analgesic Requirement	First 24 hours in the postoperative period	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.

Trial Locations

Locations (1)

Department of Surgery, JIPMER; 🇮🇳 Pondicherry, India