A Study to Assess Analgesic Efficacy of Intravenous Lignocaine
Effect of Perioperative Systemic Lignocaine on Postoperative Pain in Patients Undergoing Elective Open Abdominal Surgeries- a Double Blinded Randomized Control Trial
|Source||Jawaharlal Institute of Postgraduate Medical Education & Research|
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.
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.
|Start Date||April 2011|
|Completion Date||August 2012|
|Primary Completion Date||August 2012|
Intervention Type: Drug
Intervention Name: Intravenous lignocaine
Description: Intravenous lignocaine infusion is given in intraoperative period and till one hour post surgery.
Other Name: Lidocaine, Xylocard
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
- patients above 18 years of age
- undergoing elective open abdominal surgeries
- belonging to the American Society of Anaesthesiologists (ASA)status I,II,III
- 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
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Type: Principal Investigator
Investigator Affiliation: Jawaharlal Institute of Postgraduate Medical Education & Research
Investigator Full Name: Dr.P.Sridhar
Investigator Title: Junior resident, Department of Surgery, Principal investigator
|Has Expanded Access||No|
|Number Of Arms||2|
Label: intravenous lignocaine
Type: Active Comparator
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.
Label: normal saline
Type: Placebo Comparator
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.
|Study Design Info||
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)