A Study to Assess Analgesic Efficacy of Intravenous Lignocaine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr.P.Sridhar, Jawaharlal Institute of Postgraduate Medical Education & Research
ClinicalTrials.gov Identifier:
NCT01699919
First received: September 26, 2012
Last updated: October 3, 2012
Last verified: October 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 10, 2014