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

June 29, 2011
April 18, 2012
March 2010
January 2011   (final data collection date for primary outcome measure)
Blood pressure [ Time Frame: for 2hrs after infusion ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01387568 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Lidocaine Infusion for Major Abdominal Pediatric Surgery
The Effects of Intravenous Lidocaine Infusion During and After Major Abdominal Pediatric Surgery. A Randomized Double-blinded Study

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Elective Major Abdominal Surgery
  • 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
  • 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
  • Active Comparator: group L
    Lidocaine group
    Intervention: Drug: Lidocaine Infusion
  • Placebo Comparator: group P
    Placebo group
    Intervention: Drug: saline Infusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
February 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
1 Year to 6 Years
No
Contact information is only displayed when the study is recruiting subjects
Egypt
 
NCT01387568
MUH-AD-1-2011
Yes
Mohamed R El Tahan, Mansoura University
Mansoura University
Not Provided
Principal Investigator: Alaa El Deep, MD alaaeldeep9@hotmail.com
Mansoura University
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP