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A Study to Assess Analgesic Efficacy of Intravenous Lignocaine

NCT ID: NCT01699919

Last Updated: 2012-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-08-31

Brief Summary

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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

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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.

Conditions

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Postoperative Pain Postoperative Nausea and Vomiting Postoperative Ileus

Keywords

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perioperative lignocaine infusion elective open abdominal surgeries postoperative pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Intravenous lignocaine

Intervention Type DRUG

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

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.

Group Type PLACEBO_COMPARATOR

Intravenous lignocaine

Intervention Type DRUG

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

Interventions

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Intravenous lignocaine

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

Intervention Type DRUG

Other Intervention Names

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Lidocaine, Xylocard

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jawaharlal Institute of Postgraduate Medical Education & Research

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr.P.Sridhar

Junior resident, Department of Surgery, Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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parnandi sridhar, MBBS

Role: PRINCIPAL_INVESTIGATOR

Junior resident,JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH, PUDUCHERRY, INDIA

Locations

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Jawaharlal Institute of Postgraduate Medical Education and Research

Puducherry, Puducherry, India

Site Status

Countries

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India

References

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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.

Reference Type BACKGROUND
PMID: 3898920 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9459225 (View on PubMed)

Other Identifiers

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IEC No. : EC/2011/2/24

Identifier Type: -

Identifier Source: org_study_id