Lidocaine Infusion for Major Abdominal Pediatric Surgery

Mansoura University

Status and phase: Completed; Phase 3

Conditions: Elective Major Abdominal Surgery

Treatments: Drug: Lidocaine Infusion; Drug: saline Infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01387568

MUH-AD-1-2011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 1 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

group L

Active Comparator group

Description:

Lidocaine group

Treatment:

Drug: Lidocaine Infusion

group P

Placebo Comparator group

Description:

Placebo group

Treatment:

Drug: saline Infusion