A Study to Assess Analgesic Efficacy of Intravenous Lignocaine

Jawaharlal Institute of Postgraduate Medical Education & Research

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain; Postoperative Ileus; Postoperative Nausea and Vomiting

Treatments: Drug: Intravenous lignocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01699919

IEC No. : EC/2011/2/24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 134 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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134 participants in 2 patient groups, including a placebo group

intravenous lignocaine

Active Comparator group

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.

Treatment:

Drug: Intravenous lignocaine

normal saline

Placebo Comparator group

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.

Treatment:

Drug: Intravenous lignocaine