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Intraperitoneal Application of Levobupivacaine During Laparoscopic Surgery in Kids.

NCT02037711 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-08-05

No results posted yet for this study

Summary

Pain after laparoscopic surgery has been associated with surgical manipulations, including intraperitoneal insufflation of carbon dioxide (CO2), resulting in peritoneal stretching, diaphragmatic irritation, changes in intra-abdominal pH, and retention of the insufflated gas in the abdominal cavity after surgery. These effects may result in the irritation of peritoneal nerves causing visceral pain, as commonly reported after laparoscopic procedures in pediatrics.

The study hypothesis is that Intraperitoneal local anesthetic (levobupivacaine) instillation can provide pain relief after laparoscopic surgery, but local anesthetic distribution may not always be uniform throughout the peritoneal surface. Many methods were tried for intraperitoneal application of local anesthetics in laparoscopic surgery such as local anesthetic (LA) instillation and LA nebulization.

-But these methods are not widely used in pediatrics upon our knowledge

Conditions

Interventions

DRUG

Levobupivacaine 0.5%

Group I (Chirocaine group) (n=20): Levobupivacaine 0.5% will be instilled during insufflations of CO2 at the beginning of surgery at a dose of 2mg/kg.

DRUG

Normal saline

Group II (control group) (n=20): laparoscopy done with instillation of normal saline instead of levobupivacain

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Saad El Basha, M.D. · Cairo University

  • Maha Gmail, M.D. · Cairo University

  • Sherif M Soaida, M.D. · Cairo University

  • hagar H Refaee · Cairo University

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02037711 on ClinicalTrials.gov