NCT01699919

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P75+ for phase_4 postoperative-pain

Timeline
Completed

Started Apr 2011

Typical duration for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 4, 2012

Completed
Last Updated

October 4, 2012

Status Verified

October 1, 2012

Enrollment Period

1.3 years

First QC Date

September 26, 2012

Last Update Submit

October 3, 2012

Conditions

Postoperative PainPostoperative Nausea and VomitingPostoperative Ileus

Keywords

perioperative lignocaine infusionelective open abdominal surgeriespostoperative pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Number of patient controlled analgesia demands

    Till 24 hours post surgery

  • Total amount of morphine consumed

    till 24 hours post surgery

Other Outcomes (2)

  • Perioperative levels of inflammatory mediators

    in preoperative period, immediate post op and 24 hours post surgery

  • time of passage of flatus and stools postoperatively

    till postoperative day 7

Study Arms (2)

intravenous lignocaine

ACTIVE COMPARATOR

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

normal saline

PLACEBO COMPARATOR

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

Interventions

Intravenous lignocaineDRUG

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

Also known as: Lidocaine, Xylocard
intravenous lignocainenormal saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients above 18 years of age
  • undergoing elective open abdominal surgeries
  • belonging to the American Society of Anaesthesiologists (ASA)status I,II,III

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jawaharlal Institute of Postgraduate Medical Education and Research

Puducherry, Puducherry, 605006, India

Location

Related Publications (2)

  • 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.

    PMID: 3898920BACKGROUND

  • 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.

    PMID: 9459225BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativePostoperative Nausea and Vomiting

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsNauseaSigns and Symptoms, DigestiveVomiting

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • parnandi sridhar, MBBS

    Junior resident,JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH, PUDUCHERRY, INDIA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Junior resident, Department of Surgery, Principal investigator

Study Record Dates

First Submitted

September 26, 2012

First Posted

October 4, 2012

Study Start

April 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

October 4, 2012

Record last verified: 2012-10

Locations

IN(1)