Intraperitoneal Instillation of Levobupivacaine in Laparoscopic Pediatric Procedures
Overview
- Phase
- Phase 4
- Intervention
- Levobupivacaine 0.5%
- Conditions
- Pain
- Sponsor
- Cairo University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Postoperative Pain scoring (CHEOPS)
- Status
- Completed
- Last Updated
- 9 years ago
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
Investigators
Sherif Mohamed Abd el moneim Soaida, MD
Lecturer
Cairo University
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.
Arms & Interventions
Chirocaine group (levobupivacaine )
Intervention: Levobupivacaine 0.5%
Control group
Intervention: Normal saline
Outcomes
Primary Outcomes
Postoperative Pain scoring (CHEOPS)
Time Frame: up to six hours
pain score will be assessed immediately postoperative, then after 1 hour, 2 hours, and 6 hours.
Secondary Outcomes
- 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)
- 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)