A Study to Assess Analgesic Efficacy of Intravenous Lignocaine
Information source: Jawaharlal Institute of Postgraduate Medical Education & Research
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Pain; Postoperative Nausea and Vomiting; Postoperative Ileus
Intervention: Intravenous lignocaine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Jawaharlal Institute of Postgraduate Medical Education & Research Official(s) and/or principal investigator(s): parnandi sridhar, MBBS, Principal Investigator, Affiliation: Junior resident,JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH, PUDUCHERRY, INDIA
Summary
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.
Clinical Details
Official title: Effect of Perioperative Systemic Lignocaine on Postoperative Pain in Patients Undergoing Elective Open Abdominal Surgeries- a Double Blinded Randomized Control Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: postoperative pain scores using visual analogue scale
Secondary outcome: Number of patient controlled analgesia demandsTotal amount of morphine consumed
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry 605006, India
Additional Information
Related publications: Cassuto J, Wallin G, Högström S, Faxén A, Rimbäck G. Inhibition of postoperative pain by continuous low-dose intravenous infusion of lidocaine. Anesth Analg. 1985 Oct;64(10):971-4. Groudine SB, Fisher HA, Kaufman RP Jr, Patel MK, Wilkins LJ, Mehta SA, Lumb PD. Intravenous lidocaine speeds the return of bowel function, decreases postoperative pain, and shortens hospital stay in patients undergoing radical retropubic prostatectomy. Anesth Analg. 1998 Feb;86(2):235-9.
Starting date: April 2011
Last updated: October 3, 2012
|