A Study to Assess Analgesic Efficacy of Intravenous Lignocaine

Study Overview
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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.

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

Conditions
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Postoperative Pain, Postoperative Nausea and Vomiting, Postoperative Ileus

Intervention / Treatment
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* Drug: Intravenous lignocaine


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intravenous lignocaine<br>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<br>* Intravenous lignocaine infusion is given in intraoperative period and till one hour post surgery.<br>* Other names: Lidocaine, Xylocard;|
| Placebo Comparator: normal saline<br>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<br>* Intravenous lignocaine infusion is given in intraoperative period and till one hour post surgery.<br>* Other names: Lidocaine, Xylocard;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | till 24 hours post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patient controlled analgesia demands | The total number of times the patient presses the demand button of PCA pump are noted. | Till 24 hours post surgery | 
| Total amount of morphine consumed | The total morphine consumption till 24 hours post surgery is noted. | till 24 hours post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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perioperative lignocaine infusion, elective open abdominal surgeries, postoperative pain