A Study to Assess Analgesic Efficacy of Intravenous Lignocaine - Full Text View

Purpose

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.

Condition	Intervention	Phase
Postoperative Pain Postoperative Nausea and Vomiting Postoperative Ileus	Drug: Intravenous lignocaine	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Effect of Perioperative Systemic Lignocaine on Postoperative Pain in Patients Undergoing Elective Open Abdominal Surgeries- a Double Blinded Randomized Control Trial

Resource links provided by NLM:

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Lidocaine hydrochloride Lidocaine

U.S. FDA Resources

Further study details as provided by Jawaharlal Institute of Postgraduate Medical Education & Research:

Primary Outcome Measures:

postoperative pain scores using visual analogue scale [ Time Frame: till 24 hours post surgery ] [ Designated as safety issue: No ]
Postoperative pain scores are assessed in the patients using a visual analogue scale in the first 24 hours post surgery

Secondary Outcome Measures:

Number of patient controlled analgesia demands [ Time Frame: Till 24 hours post surgery ] [ Designated as safety issue: No ]
The total number of times the patient presses the demand button of PCA pump are noted.
Total amount of morphine consumed [ Time Frame: till 24 hours post surgery ] [ Designated as safety issue: No ]
The total morphine consumption till 24 hours post surgery is noted.

Other Outcome Measures:

Perioperative levels of inflammatory mediators [ Time Frame: in preoperative period, immediate post op and 24 hours post surgery ] [ Designated as safety issue: No ]
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.
time of passage of flatus and stools postoperatively [ Time Frame: till postoperative day 7 ] [ Designated as safety issue: No ]
Postoperative bowel function recovery will be assessed by noting the time of first passage of flatus and stools postoperatively

Enrollment:	134
Study Start Date:	April 2011
Study Completion Date:	August 2012
Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: Lidocaine, Xylocard

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01699919

Locations

India
Jawaharlal Institute of Postgraduate Medical Education and Research
Puducherry, India, 605006

Sponsors and Collaborators

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

More Information

Publications:

Cassuto J, Wallin G, Högström S, Faxén A, Rimbäck G. Inhibition of postoperative pain by continuous low-dose intravenous infusion of lidocaine. Anesth Analg. 1985 Oct;64(10):971-4.

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.

Responsible Party:	Dr.P.Sridhar, Junior resident, Department of Surgery, Principal investigator, Jawaharlal Institute of Postgraduate Medical Education & Research
ClinicalTrials.gov Identifier:	NCT01699919 History of Changes
Other Study ID Numbers:	IEC No. : EC/2011/2/24
Study First Received:	September 26, 2012
Last Updated:	October 3, 2012
Health Authority:	India: Institutional Review Board

Keywords provided by Jawaharlal Institute of Postgraduate Medical Education & Research:

perioperative lignocaine infusion
elective open abdominal surgeries
postoperative pain

Additional relevant MeSH terms:

Pain, Postoperative
Vomiting
Postoperative Nausea and Vomiting
Ileus
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Nausea
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases

Digestive System Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 16, 2013