Intraperitoneal Application of Levobupivacaine During Laparoscopic Surgery in Kids.

Study Overview
=================
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

Official Title
-----------------
Intraperitoneal Instillation of Levobupivacaine in Laparoscopic Pediatric Procedures

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Levobupivacaine 0.5%
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient undergoing laparoscopic surgeries Pediatric weighing 4 kg or more Patients with free medical history Exclusion Criteria: Parents refusal Known allergy to levobupivacaine Acute preoperative pain other than biliary colic chronic pain treatment or antiepileptic therapy Severe hepatic or renal impairment Cognitive impairment or communication problems.

Ages Eligible for Study
-----------------
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chirocaine group (levobupivacaine )<br> | Drug: Levobupivacaine 0.5%<br>* 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.<br>|
| Sham Comparator: Control group<br> | Drug: Normal saline<br>* Group II (control group) (n=20): laparoscopy done with instillation of normal saline instead of levobupivacain<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain scoring (CHEOPS) | pain score will be assessed immediately postoperative, then after 1 hour, 2 hours, and 6 hours. | up to six hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in Haemodynamics including ( Heart Rate) | 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) | during the period of the operation (Preoperative, post-induction, after instillation of levobupivacaine or saline, postoperative for 6 hours at 0-1-2-6 | 
| changes in Haemodynamics including ( Non Invasive Blood Pressure) | 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) | during the period of the operation (Preoperative, post-induction, after instillation of levobupivacaine or saline, postoperative for 6 hours at 0-1-2- 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laparoscopic, Levobupivacaine, Pediatric, Anesthesia, Instillation, surgeries