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Clinical Trials/NCT01387568
NCT01387568
Completed
Phase 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 enrollmentMarch 2010

Overview

Phase
Phase 3
Intervention
Lidocaine Infusion
Conditions
Elective Major Abdominal Surgery
Sponsor
Mansoura University
Enrollment
80
Locations
1
Primary Endpoint
Blood pressure
Status
Completed
Last Updated
14 years ago

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.

Registry
clinicaltrials.gov
Start Date
March 2010
End Date
February 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohamed R El Tahan

Associate Professor of Anesthesiology

Mansoura University

Eligibility Criteria

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

Lidocaine group

Intervention: Lidocaine Infusion

group P

Placebo group

Intervention: saline Infusion

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)

Study Sites (1)

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