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A Study to Assess Analgesic Efficacy of Intravenous Lignocaine

Primary Purpose

Postoperative Pain, Postoperative Nausea and Vomiting, Postoperative Ileus

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Intravenous lignocaine
Sponsored by
Jawaharlal Institute of Postgraduate Medical Education & Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring perioperative lignocaine infusion, elective open abdominal surgeries, postoperative pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jawaharlal Institute of Postgraduate Medical Education and Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

intravenous lignocaine

normal saline

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 26, 2012
Last Updated
October 3, 2012
Sponsor
Jawaharlal Institute of Postgraduate Medical Education & Research
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1. Study Identification

Unique Protocol Identification Number
NCT01699919
Brief Title
A Study to Assess Analgesic Efficacy of Intravenous Lignocaine
Official Title
Effect of Perioperative Systemic Lignocaine on Postoperative Pain in Patients Undergoing Elective Open Abdominal Surgeries- a Double Blinded Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jawaharlal Institute of Postgraduate Medical Education & Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Postoperative Nausea and Vomiting, Postoperative Ileus
Keywords
perioperative lignocaine infusion, elective open abdominal surgeries, postoperative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intravenous lignocaine
Arm Type
Active Comparator
Arm 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.
Arm Title
normal saline
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Intravenous lignocaine
Other Intervention Name(s)
Lidocaine, Xylocard
Intervention Description
Intravenous lignocaine infusion is given in intraoperative period and till one hour post surgery.
Primary Outcome Measure Information:
Title
postoperative pain scores using visual analogue scale
Description
Postoperative pain scores are assessed in the patients using a visual analogue scale in the first 24 hours post surgery
Time Frame
till 24 hours post surgery
Secondary Outcome Measure Information:
Title
Number of patient controlled analgesia demands
Description
The total number of times the patient presses the demand button of PCA pump are noted.
Time Frame
Till 24 hours post surgery
Title
Total amount of morphine consumed
Description
The total morphine consumption till 24 hours post surgery is noted.
Time Frame
till 24 hours post surgery
Other Pre-specified Outcome Measures:
Title
Perioperative levels of inflammatory mediators
Description
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 Frame
in preoperative period, immediate post op and 24 hours post surgery
Title
time of passage of flatus and stools postoperatively
Description
Postoperative bowel function recovery will be assessed by noting the time of first passage of flatus and stools postoperatively
Time Frame
till postoperative day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
parnandi sridhar, MBBS
Organizational Affiliation
Junior resident,JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH, PUDUCHERRY, INDIA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jawaharlal Institute of Postgraduate Medical Education and Research
City
Puducherry
ZIP/Postal Code
605006
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
3898920
Citation
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.
Results Reference
background
PubMed Identifier
9459225
Citation
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.
Results Reference
background

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A Study to Assess Analgesic Efficacy of Intravenous Lignocaine

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