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Lidocaine Infusion for Major Abdominal Pediatric Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mohamed R El Tahan, Mansoura University
ClinicalTrials.gov Identifier:
NCT01387568
First received: June 29, 2011
Last updated: April 18, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention Phase
Elective Major Abdominal Surgery
 Drug: Lidocaine Infusion
Drug: saline Infusion
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • Blood pressure [ Time Frame: for 2hrs after infusion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Plasma Cortisol [ Time Frame: for 24 hrs after infusion ] [ Designated as safety issue: No ]
  • Serum lidocaine [ Time Frame: 6 hrs after infusion ] [ Designated as safety issue: Yes ]
    The TDx/ TDx FLx (Abbot Diagnostic, USA) lidocaine assay was used for quantitative measurement of serum lidocaine

  • Heart rate (HR) [ Time Frame: for 6 hrs after infusion ] [ Designated as safety issue: Yes ]
  • Pain scales [ Time Frame: 24 hrs postoperative ] [ Designated as safety issue: No ]
    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


Enrollment: 80
Study Start Date: March 2010
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   1 Year to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01387568

Locations
Egypt
Anesthesia Dept, Mansoura University
Mansoura, DK, Egypt, 050
Sponsors and Collaborators
Mansoura University
Investigators
Principal Investigator: Alaa El Deep, MD alaaeldeep9@hotmail.com
  More Information

No publications provided

Responsible Party: Mohamed R El Tahan, Associate Professor of Anesthesiology, Mansoura University
ClinicalTrials.gov Identifier: NCT01387568     History of Changes
Other Study ID Numbers: MUH-AD-1-2011
Study First Received: June 29, 2011
Last Updated: April 18, 2012
Health Authority: Egypt: Institutional Review Board

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013