Pain
Conditions
Keywords
Laparoscopic, Levobupivacaine, Pediatric, Anesthesia, Instillation, surgeries
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
Interventions
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.
DRUGNormal saline
Group II (control group) (n=20): laparoscopy done with instillation of normal saline instead of levobupivacain
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
Other
| Measure | Time frame |
|---|---|
| Indirect signs of local anaesthetic toxicity (intraoperative arrhythmias and delayed awakening) | From time of instillation of levobupivacaine till 6 hours postoperative. |
Countries
Egypt
Outcome results
None listed