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Clinical Trials/NCT01387568
NCT01387568CompletedPhase 3

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

Mansoura University1 site in 1 country80 target enrollmentStarted: March 2010Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
80
Locations
1
Primary Endpoint
Blood pressure

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
1 Year to 6 Years (Child)
Sex
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

Arms & Interventions

group L

Active Comparator

Lidocaine group

Intervention: Lidocaine Infusion (Drug)

group P

Placebo Comparator

Placebo group

Intervention: saline Infusion (Drug)

Outcomes

Primary Outcomes

Blood pressure

Time Frame: for 2hrs after infusion

Secondary Outcomes

  • Plasma Cortisol(for 24 hrs after infusion)
  • Serum lidocaine(6 hrs after infusion)
  • Heart rate (HR)(for 6 hrs after infusion)
  • Pain scales(24 hrs postoperative)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohamed R El Tahan

Associate Professor of Anesthesiology

Mansoura University

Study Sites (1)

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