A Study to Assess Analgesic Efficacy of Intravenous Lignocaine

Effect of Perioperative Systemic Lignocaine on Postoperative Pain in Patients Undergoing Elective Open Abdominal Surgeries- a Double Blinded Randomized Control Trial

Sponsors

Lead Sponsor: Jawaharlal Institute of Postgraduate Medical Education & Research

Source 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.

Overall Status Completed
Start Date April 2011
Completion Date August 2012
Primary Completion Date August 2012
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
postoperative pain scores using visual analogue scale till 24 hours post surgery
Secondary Outcome
Measure Time Frame
Number of patient controlled analgesia demands Till 24 hours post surgery
Total amount of morphine consumed till 24 hours post surgery
Enrollment 134
Condition
Intervention

Intervention Type: Drug

Intervention Name: Intravenous lignocaine

Description: Intravenous lignocaine infusion is given in intraoperative period and till one hour post surgery.

Other Name: Lidocaine, Xylocard

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
parnandi sridhar, MBBS Principal Investigator Junior resident,JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH, PUDUCHERRY, INDIA
Location
Facility: Jawaharlal Institute of Postgraduate Medical Education and Research
Location Countries

India

Verification Date

October 2012

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Jawaharlal Institute of Postgraduate Medical Education & Research

Investigator Full Name: Dr.P.Sridhar

Investigator Title: Junior resident, Department of Surgery, Principal investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: intravenous lignocaine

Type: Active Comparator

Description: 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.

Label: normal saline

Type: Placebo Comparator

Description: 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.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov