Clinical trial NCT02723487: Ultrasound Guided Transversus Abdominis Plane Block in Pediatric Surgery
Official title: Postoperative Analgesic Efficacy of Transversus Abdominis Plane Block by Bupivacaine With Two Different Concentrations in Pediatric Patient Undergoing Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Pain
Keywords: TAP block
pediatric
Laparoscopic
postoperative pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-03-30
Enrollment: 60
Sex: MALE
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective of this study is to assess differences in postoperative pain experienced by pediatric patients having transversus abdominis plane block block with bupivacaine (0.125% and 0.25%) compared with control group will receive conventional iv analgesia after Laparoscopic surgery.

Detailed description: A prospective randomized controlled double blind study using a computer generated randomization will be conducted in Assiut University Hospitals and carried on 60 pediatric patients undergoing laparoscopic surgery under general anesthesia.

After induction of general anesthesia and endotracheal intubation, patients in group B and group C will be placed in the supine position and transversus abdominis plane block will be performed under ultrasound guidance. After skin preparation, the linear ultrasound probe connected to a portable ultrasound unit will be placed in the axial plane across the mid-axillary line midway between the costal margin and the highest point of iliac crest. needle attached to a syringe filled with the Local anesthetic solution will be inserted until it reaches the plane between the internal oblique and transversus abdominis muscles.

After careful aspiration to exclude vascular puncture, injection of bupivacaine will be performed leading to separation between the internal oblique and the transversus abdominis muscles which will appear as a hypoechoic space on ultrasound. This procedure will be repeated on the opposite side .

Laparoscopic procedure will be started 20 minutes after completion of bilateral transversus abdominis plane block and 0.01 mg/kg iv atropine will be given before pneumoperitonem. Intra abdominal pressure will be maintained at 10-12 mmHg.

The use of opioids during the procedure will based on the cardiovascular response to stimulation; a heart rate increase of 20% from baseline will be interpreted as insufficient analgesia and will be treated with fentanyl in doses of 1mcg / kg.

Eligibility criteria: Inclusion Criteria:

* ASA I-II physical status patients.
* Genders Eligible for Study :male.
* All children scheduled for laparoscopic surgery between the ages of 1and 5 years.
* Duration of Laparoscopic procedure not exceeding 90 minutes.
* Written informed consent from parent of guardian .

Exclusion Criteria:

* Sensitivities to local anesthetics.
* Significant renal, liver, or cardiac disease.
* Surgery requiring an open procedure

Primary outcomes:
measure: pain score
timeFrame: 12 hours postoperative
Secondary outcomes:
measure: Total intraoperative fentanyl consumption
timeFrame: 12 hours postoperative
measure: number of participants with incidence of nausea
timeFrame: 12 hours postoperative
measure: number of participants with incidence of hematoma
timeFrame: 12 hours postoperative
measure: number of participants with incidence of infection
timeFrame: 12 hours postoperative
measure: Total postoperative paracetamol consumption
timeFrame: 12 hours postoperative
measure: Number of participants with incidence of vomiting
timeFrame: 12 hours postoperative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university faculty of medicine
Study officials:
affiliation: Assistant profossor
name: Abdelrady s Ibrahim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Long JB, Birmingham PK, De Oliveira GS Jr, Schaldenbrand KM, Suresh S. Transversus abdominis plane block in children: a multicenter safety analysis of 1994 cases from the PRAN (Pediatric Regional Anesthesia Network) database. Anesth Analg. 2014 Aug;119(2):395-399. doi: 10.1213/ANE.0000000000000284.