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NCT Number: NCT01699919

A Study to Assess Analgesic Efficacy of Intravenous Lignocaine

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Jawaharlal Institute of Postgraduate Medical Education and Research

Puducherry, 605006, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous lignocaine

Drug

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

Other names: Lidocaine, Xylocard

Primary outcomes

  1. postoperative pain scores using visual analogue scale

    Time frame: till 24 hours post surgery

    Postoperative pain scores are assessed in the patients using a visual analogue scale in the first 24 hours post surgery

Secondary outcomes

  1. Number of patient controlled analgesia demands

    Time frame: Till 24 hours post surgery

    The total number of times the patient presses the demand button of PCA pump are noted.

  2. Total amount of morphine consumed

    Time frame: till 24 hours post surgery

    The total morphine consumption till 24 hours post surgery is noted.

Other outcomes

  1. Perioperative levels of inflammatory mediators

    Time frame: in preoperative period, immediate post op and 24 hours post surgery

    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.

  2. time of passage of flatus and stools postoperatively

    Time frame: till postoperative day 7

    Postoperative bowel function recovery will be assessed by noting the time of first passage of flatus and stools postoperatively

Sponsors and collaborators

Lead sponsor

Jawaharlal Institute of Postgraduate Medical Education & Research

Other Gov

Registry information

Official study title

Effect of Perioperative Systemic Lignocaine on Postoperative Pain in Patients Undergoing Elective Open Abdominal Surgeries- a Double Blinded Randomized Control Trial

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 4, 2012
Registry last updated
Oct 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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