Lidocaine Infusion for Major Abdominal Pediatric Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Elective Major Abdominal Surgery

Intervention / Treatment
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* Drug: Lidocaine Infusion
* Drug: saline Infusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group L<br>Lidocaine group | Drug: Lidocaine Infusion<br>* 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<br>|
| Placebo Comparator: group P<br>Placebo group | Drug: saline Infusion<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | for 2hrs after infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Cortisol |  | for 24 hrs after infusion | 
| Serum lidocaine | The TDx/ TDx FLx (Abbot Diagnostic, USA) lidocaine assay was used for quantitative measurement of serum lidocaine | 6 hrs after infusion | 
| Heart rate (HR) |  | for 6 hrs after infusion | 
| Pain scales | 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 | 24 hrs postoperative |