A Study to Assess Analgesic Efficacy of Intravenous Lignocaine

Phase 4

Completed

• Conditions: Postoperative Pain; Postoperative Nausea and Vomiting; Postoperative Ileus
• Interventions: Drug: Intravenous lignocaine

• Registration Number: NCT01699919
• Lead Sponsor: Jawaharlal Institute of Postgraduate Medical Education & Research

Brief Summary

The primary objectives of this study are to analyse the effect of perioperative systemic infusion of lignocaine on postoperative pain, postoperative nausea and vomiting and perioperative levels of inflammatory mediators in patients undergoing elective open abdominal surgeries.

The secondary parameters which will be observed during the study are the time to passage of flatus and stools postoperatively.

Detailed Description

Patients will be randomized into two groups- A and B, to receive an intravenous infusion of lignocaine or saline,respectively, as a bolus of 1.5mg/kg at the time of intubation followed by an infusion at a rate of 1.5mg/kg/hr continued throughout the surgery and till one hour postop. Postoperative analgesia will be provided through Patient Controlled Analgesia (PCA) pump providing morphine. Postoperative pain scores will be noted at immediate postoperative and at 6, 18, 24 hours post surgery. The number of PCA demands and cumulative morphine consumption till 24 hours post surgery will be noted. The incidence of postoperative nausea and vomiting is recorded. The time to first passage of flatus and stools postoperatively will be noted. Levels of total leukocyte count, c-reactive protein (CRP) and interleukin-6(IL-6) will be noted in preoperative, immediate post operative and 24 hours post surgery.

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Study First Submitted: 2012-09-26
• Status Verified: 2012-10
• Study First Submitted QC: 2012-10-03
• Last Update Submitted: 2012-10-03
• Study First Posted: 2012-10-04
• Last Update Posted: 2012-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

• patients above 18 years of age
• undergoing elective open abdominal surgeries
• belonging to the American Society of Anaesthesiologists (ASA)status I,II,III

Exclusion Criteria

• patients sensitive to lignocaine,
• patients suffering from cardiovascular diseases or with preoperative changes on electrocardiogram
• patients on beta blocker drugs
• patients on opioid drugs for prolonged period
• patients with functional bowel disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normal saline	Intravenous lignocaine	Normal saline will be given as a bolus at the time of intubation and saline infusion given to patients in the control group during the surgery and till one hour post surgery.
intravenous lignocaine	Intravenous lignocaine	Intravenous lignocaine will be given as a bolus of 1.5mg/kg at the time of intubation followed by an infusion at a rate of 1.5mg/kg/hr throughout surgery and till one hour post surgery.

Primary Outcome Measures

Name	Time	Method
postoperative pain scores using visual analogue scale	till 24 hours post surgery	Postoperative pain scores are assessed in the patients using a visual analogue scale in the first 24 hours post surgery

Secondary Outcome Measures

Name	Time	Method
Number of patient controlled analgesia demands	Till 24 hours post surgery	The total number of times the patient presses the demand button of PCA pump are noted.
Total amount of morphine consumed	till 24 hours post surgery	The total morphine consumption till 24 hours post surgery is noted.

Trial Locations

Locations (1)

Jawaharlal Institute of Postgraduate Medical Education and Research; 🇮🇳 Puducherry, India