Clinical trial NCT01699919: A Study to Assess Analgesic Efficacy of Intravenous Lignocaine
Official title: Effect of Perioperative Systemic Lignocaine on Postoperative Pain in Patients Undergoing Elective Open Abdominal Surgeries- a Double Blinded Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Postoperative Nausea and Vomiting
Postoperative Ileus
Keywords: perioperative lignocaine infusion
elective open abdominal surgeries
postoperative pain
Lead sponsor: Jawaharlal Institute of Postgraduate Medical Education & Research
Sponsor class: OTHER_GOV
First posted: 2012-10-04
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: postoperative pain scores using visual analogue scale
timeFrame: till 24 hours post surgery
Secondary outcomes:
measure: Number of patient controlled analgesia demands
timeFrame: Till 24 hours post surgery
measure: Total amount of morphine consumed
timeFrame: till 24 hours post surgery
Other outcomes:
measure: Perioperative levels of inflammatory mediators
timeFrame: in preoperative period, immediate post op and 24 hours post surgery
measure: time of passage of flatus and stools postoperatively
timeFrame: till postoperative day 7
Locations:
city: Puducherry
country: India
facility: Jawaharlal Institute of Postgraduate Medical Education and Research
Study officials:
affiliation: Junior resident,JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH, PUDUCHERRY, INDIA
name: parnandi sridhar, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cassuto J, Wallin G, Hogstrom S, Faxen A, Rimback G. Inhibition of postoperative pain by continuous low-dose intravenous infusion of lidocaine. Anesth Analg. 1985 Oct;64(10):971-4.
citation: 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. doi: 10.1097/00000539-199802000-00003.