Intraperitoneal Application of Levobupivacaine During Laparoscopic Surgery in Kids.

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: Levobupivacaine 0.5%; Drug: Normal saline

• Registration Number: NCT02037711
• Lead Sponsor: Cairo University

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Study First Submitted: 2013-12-23
• Study First Submitted QC: 2014-01-15
• Study First Posted: 2014-01-16
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-03
• Last Update Posted: 2016-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chirocaine group (levobupivacaine )	Levobupivacaine 0.5%	-
Control group	Normal saline	-

Primary Outcome Measures

Name	Time	Method
Postoperative Pain scoring (CHEOPS)	up to six hours	pain score will be assessed immediately postoperative, then after 1 hour, 2 hours, and 6 hours.

Secondary Outcome Measures

Name	Time	Method
changes in Haemodynamics including ( Non Invasive Blood Pressure)	during the period of the operation (Preoperative, post-induction, after instillation of levobupivacaine or saline, postoperative for 6 hours at 0-1-2- 6	Represented as mean and standard deviation, hemodynamic variables will be measured during the the surgery starting preoperatively, following induction of anesthesia, during the procedure and postoperatively (6 hours postoperative)
changes in Haemodynamics including ( Heart Rate)	during the period of the operation (Preoperative, post-induction, after instillation of levobupivacaine or saline, postoperative for 6 hours at 0-1-2-6	Represented as mean and standard deviation, hemodynamic variables will be measured during the the surgery starting preoperatively, following induction of anesthesia, during the procedure and postoperatively (6 hours postoperative)

Trial Locations

Locations (1)

Faculty of medicine, Cairo University; 🇪🇬 Cairo, Egypt