Clinical trial NCT02037711: Intraperitoneal Application of Levobupivacaine During Laparoscopic Surgery in Kids.
Official title: Intraperitoneal Instillation of Levobupivacaine in Laparoscopic Pediatric Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Laparoscopic
Levobupivacaine
Pediatric
Anesthesia
Instillation
surgeries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2014-01-16
Enrollment: 40
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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


Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative Pain scoring (CHEOPS)
timeFrame: up to six hours
Secondary outcomes:
measure: changes in Haemodynamics including ( Heart Rate)
timeFrame: during the period of the operation (Preoperative, post-induction, after instillation of levobupivacaine or saline, postoperative for 6 hours at 0-1-2-6
measure: changes in Haemodynamics including ( Non Invasive Blood Pressure)
timeFrame: during the period of the operation (Preoperative, post-induction, after instillation of levobupivacaine or saline, postoperative for 6 hours at 0-1-2- 6
Other outcomes:
measure: Indirect signs of local anaesthetic toxicity (intraoperative arrhythmias and delayed awakening)
timeFrame: From time of instillation of levobupivacaine till 6 hours postoperative.
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine, Cairo University
Study officials:
affiliation: Cairo University
name: Saad El Basha, M.D.
role: STUDY_CHAIR
affiliation: Cairo University
name: Maha Gmail, M.D.
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Sherif M Soaida, M.D.
role: STUDY_DIRECTOR
affiliation: Cairo University
name: hagar H Refaee
role: PRINCIPAL_INVESTIGATOR
References: