Lidocaine Infusion for Major Abdominal Pediatric Surgery

Sponsor

Mansoura University (Other)

Overall Status

Completed

CT.gov ID

NCT01387568

Collaborator

(none)

Enrollment

Location

Arms

11.1

Duration (Months)

7.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this study, the investigators hypothesized that perioperative i.v. infusion of lidocaine in major abdominal pediatric surgery, may have a beneficial effect on hemodynamic and hormonal responses. Also, it could decrease the hospital stay, opioid requirement and hasten return of bowel function.

Condition or Disease	Intervention/Treatment	Phase
Elective Major Abdominal Surgery	Drug: Lidocaine Infusion Drug: saline Infusion	Phase 3

Detailed Description

The inflammatory response after major abdominal surgery is of great importance for patients, physicians and perioperative medicine1. Perioperative excessive stimulation of the inflammatory and hemostatic systems may result in development of postoperative ileus, ischemia-reperfusion syndromes, hypercoagulation syndromes (e.g. deep venous thrombosis) and pain excessive inflammatory response such as impaired gastrointestinal motility, so modulation of inflammatory responses may decrease severity of such complications 2,3.

Intravenous lidocaine, a local anesthetic, has been shown to improve postoperative analgesia, reduce postoperative opioid requirements, accelerate postoperative recovery of bowel function, attenuate postoperative fatigue, reduced the duration of hospitalization, and facilitate acute rehabilitation in patients undergoing laparoscopic abdominal surgery 4. Administration of local anesthetics to epidural space has analgesic effect, blunt stress response; provide rapid mobilization, early extubation with rapid recovery of bowel function 5. However, insertion of an epidural catheter carries risks especially in pediatric populations. So, systemic lidocaine may become another strategy for improving perioperative outcome which is safe and effective2.

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

The Effects of Intravenous Lidocaine Infusion During and After Major Abdominal Pediatric Surgery. A Randomized Double-blinded Study

Study Start Date :

Mar 1, 2010

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: group L Lidocaine group	Drug: Lidocaine Infusion children in group L received i.v. lidocaine 1.5 mg/kg followed by infusion at 1.5 mg. kg-1.h-1. and were continued up to 6 hours postoperatively
Placebo Comparator: group P Placebo group	Drug: saline Infusion children in group P received i.v. saline 0.9% 1 ml/kg followed by infusion at 0.1 ml. kg-1.h-1,and were continued up to 6 hours postoperatively

Arm

Intervention/Treatment

Active Comparator: group L

Lidocaine group

Drug: Lidocaine Infusion

children in group L received i.v. lidocaine 1.5 mg/kg followed by infusion at 1.5 mg. kg-1.h-1. and were continued up to 6 hours postoperatively

Placebo Comparator: group P

Placebo group

Drug: saline Infusion

children in group P received i.v. saline 0.9% 1 ml/kg followed by infusion at 0.1 ml. kg-1.h-1,and were continued up to 6 hours postoperatively

Outcome Measures

Primary Outcome Measures

Blood pressure [for 2hrs after infusion]

Secondary Outcome Measures

Plasma Cortisol [for 24 hrs after infusion]
Serum lidocaine [6 hrs after infusion]
The TDx/ TDx FLx (Abbot Diagnostic, USA) lidocaine assay was used for quantitative measurement of serum lidocaine
Heart rate (HR) [for 6 hrs after infusion]
Pain scales [24 hrs postoperative]
In the postanaesthetic care unit (PACU), children were assessed for pain every 10 min by the trained nurse blinded to group assignment, using 1 of 2 pain scales according to child comprehension: a 0- to 10-point visual analog scale (VAS), or FLACC Scale (Face, Legs,Activity, Cry, Consolability). FLACC is an observer assessment based 5 items and each item is graded from 0 to 2

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 6 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Pediatric
Abdominal surgery
ASA class I and II

Exclusion Criteria:

history of hepatic diseases
history of cardiac diseases
history of renal diseases
allergy to local anesthetics
epilepsy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anesthesia Dept, Mansoura University	Mansoura	DK	Egypt	050

Sponsors and Collaborators

Mansoura University

Investigators

Principal Investigator: Alaa El Deep, MD, alaaeldeep9@hotmail.com

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed R El Tahan, Associate Professor of Anesthesiology, Mansoura University

ClinicalTrials.gov Identifier:

NCT01387568

Other Study ID Numbers:

MUH-AD-1-2011

First Posted:

Jul 4, 2011

Last Update Posted:

Apr 20, 2012

Last Verified:

Apr 1, 2012

Additional relevant MeSH terms:

Lidocaine

Study Results

No Results Posted as of Apr 20, 2012