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Lidocaine Infusion for Major Abdominal Pediatric Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01387568
Recruitment Status : Completed
First Posted : July 4, 2011
Last Update Posted : April 20, 2012
Information provided by (Responsible Party):
Mohamed R El Tahan, Mansoura University

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 Type : Interventional  (Clinical Trial)
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 : March 2010
Primary Completion Date : January 2011
Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Blood pressure [ Time Frame: for 2hrs after infusion ]

Secondary Outcome Measures :
  1. Plasma Cortisol [ Time Frame: for 24 hrs after infusion ]
  2. Serum lidocaine [ Time Frame: 6 hrs after infusion ]
    The TDx/ TDx FLx (Abbot Diagnostic, USA) lidocaine assay was used for quantitative measurement of serum lidocaine

  3. Heart rate (HR) [ Time Frame: for 6 hrs after infusion ]
  4. Pain scales [ Time Frame: 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

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Ages Eligible for Study:   1 Year to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01387568

Anesthesia Dept, Mansoura University
Mansoura, DK, Egypt, 050
Sponsors and Collaborators
Mansoura University
Principal Investigator: Alaa El Deep, MD

Responsible Party: Mohamed R El Tahan, Associate Professor of Anesthesiology, Mansoura University Identifier: NCT01387568     History of Changes
Other Study ID Numbers: MUH-AD-1-2011
First Posted: July 4, 2011    Key Record Dates
Last Update Posted: April 20, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action