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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Postoperative Nausea and Vomiting; Postoperative Ileus
• Intervention / Treatment: Drug: Intravenous lignocaine

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 Type: Interventional
• Enrollment (Actual): 134
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Puducherry, India, 605006
    • Jawaharlal Institute Of Postgraduate Medical Education And Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Intravenous lignocaine; Intravenous lignocaine infusion is given in intraoperative period and till one hour post surgery.; Other Names: Lidocaine, Xylocard
Placebo Comparator: normal saline; 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.	Drug: Intravenous lignocaine; Intravenous lignocaine infusion is given in intraoperative period and till one hour post surgery.; Other Names: Lidocaine, Xylocard

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain scores using visual analogue scale	Postoperative pain scores are assessed in the patients using a visual analogue scale in the first 24 hours post surgery	till 24 hours post surgery

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative levels of inflammatory mediators	Blood samples will be collected for the analysis of total leukocyte count, C-reactive protein and Interleukin-6 levels in the preoperative period, immediate postoperative and at 24 hours post surgery.	in preoperative period, immediate post op and 24 hours post surgery
time of passage of flatus and stools postoperatively	Postoperative bowel function recovery will be assessed by noting the time of first passage of flatus and stools postoperatively	till postoperative day 7

Collaborators and Investigators

• Sponsor: Jawaharlal Institute of Postgraduate Medical Education & Research
• Investigators: Principal Investigator: parnandi sridhar, MBBS, Junior resident,JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH, PUDUCHERRY, INDIA

Publications and helpful links

General Publications

• Groudine SB, Fisher HA, Kaufman RP Jr, Patel MK, Wilkins LJ, Mehta SA, Lumb PD. Intravenous lidocaine speeds the return of bowel function, decreases postoperative pain, and shortens hospital stay in patients undergoing radical retropubic prostatectomy. Anesth Analg. 1998 Feb;86(2):235-9. doi: 10.1097/00000539-199802000-00003.
• Cassuto J, Wallin G, Hogstrom S, Faxen A, Rimback G. Inhibition of postoperative pain by continuous low-dose intravenous infusion of lidocaine. Anesth Analg. 1985 Oct;64(10):971-4.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: September 26, 2012
• First Submitted That Met QC Criteria: October 3, 2012
• First Posted (Estimate): October 4, 2012

Study Record Updates

• Last Update Posted (Estimate): October 4, 2012
• Last Update Submitted That Met QC Criteria: October 3, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: postoperative pain; perioperative lignocaine infusion; elective open abdominal surgeries
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Nausea; Pain, Postoperative; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: IEC No. : EC/2011/2/24