Intraperitoneal Application of Levobupivacaine During Laparoscopic Surgery in Kids.

Cairo University (CU)

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Levobupivacaine 0.5%; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02037711

SMS2013

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: Under 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

40 participants in 2 patient groups

Chirocaine group (levobupivacaine )

Active Comparator group

Treatment:

Drug: Levobupivacaine 0.5%

Control group

Sham Comparator group

Treatment:

Drug: Normal saline