A Study to Assess Analgesic Efficacy of Intravenous Lignocaine

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01699919
• Other study ID #: IEC No. : EC/2011/2/24
• Status: Completed
• Phase: Phase 4
• First received: September 26, 2012
• Last updated: October 3, 2012
• Start date: April 2011
• Est. completion date: August 2012

Study information

• Verified date: October 2012
• Source: Jawaharlal Institute of Postgraduate Medical Education & Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Ileus
• Postoperative Nausea and Vomiting
• Postoperative Pain

Intervention

Drug:
• Intravenous lignocaine
Intravenous lignocaine infusion is given in intraoperative period and till one hour post surgery.

Locations

Country	Name	City	State
India	Jawaharlal Institute of Postgraduate Medical Education and Research	Puducherry

Sponsors (1)

Lead Sponsor	Collaborator
Jawaharlal Institute of Postgraduate Medical Education & Research

Country where clinical trial is conducted

India, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Perioperative levels of inflammatory mediators	Blood samples will be collected for the analysis of total leukocyte count, C-reactive protein and Interleukin-6 levels in the preoperative period, immediate postoperative and at 24 hours post surgery.	in preoperative period, immediate post op and 24 hours post surgery	No
Other	time of passage of flatus and stools postoperatively	Postoperative bowel function recovery will be assessed by noting the time of first passage of flatus and stools postoperatively	till postoperative day 7	No
Primary	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	No
Secondary	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	No
Secondary	Total amount of morphine consumed	The total morphine consumption till 24 hours post surgery is noted.	till 24 hours post surgery	No