Intraperitoneal Application of Levobupivacaine During Laparoscopic Surgery in Kids.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-11-30

Brief Summary

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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

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Chirocaine group (levobupivacaine )

Group Type ACTIVE_COMPARATOR

Levobupivacaine 0.5%

Intervention Type DRUG

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.

Control group

Group Type SHAM_COMPARATOR

Normal saline

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Normal saline

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patient undergoing laparoscopic surgeries
2. Pediatric weighing 4 kg or more
3. Patients with free medical history

Exclusion Criteria

1. Parents refusal
2. Known allergy to levobupivacaine
3. Acute preoperative pain other than biliary colic
4. chronic pain treatment or antiepileptic therapy
5. Severe hepatic or renal impairment
6. Cognitive impairment or communication problems.

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes