Lidocaine Infusion for Major Abdominal Pediatric Surgery

Phase 3

Completed

• Conditions: Elective Major Abdominal Surgery
• Interventions: Drug: Lidocaine Infusion; Drug: saline Infusion

• Registration Number: NCT01387568
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-03
• Primary Completion: 2011-01
• Study Completion: 2011-02
• Study First Submitted: 2011-06-29
• Study First Submitted QC: 2011-07-01
• Study First Posted: 2011-07-04
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-18
• Last Update Posted: 2012-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group L	Lidocaine Infusion	Lidocaine group
group P	saline Infusion	Placebo group

Primary Outcome Measures

Name	Time	Method
Blood pressure	for 2hrs after infusion

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Anesthesia Dept, Mansoura University; 🇪🇬 Mansoura, DK, Egypt