Ultrasound Guided Transversus Abdominis Plane Block in Pediatric Surgery

Postoperative Analgesic Efficacy of Transversus Abdominis Plane Block by Bupivacaine With Two Different Concentrations in Pediatric Patient Undergoing Laparoscopic Surgery

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Bupivacaine 0.125%; Drug: Bupivacaine 0.25%

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Assiut university faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group A; Control
Active Comparator: Group B; patients will receive bilateral ultrasound guided TAP block using bupivacaine (0.125%), 0.5 ml/kg on each side.	Drug: Bupivacaine 0.125%; Patients will receive bilateral Transversus Abdominis Plane Block guided by ultrasound device using bupivacaine (Marcaine, 0.125%), 0.5 ml/kg on each side.; Other Names: Plain marcaine
Active Comparator: Group C; patients will receive bilateral ultrasound guided TAP block using bupivacaine (0.25%), 0.5 ml/kg on each side.	Drug: Bupivacaine 0.25%; Patients will receive bilateral Transversus Abdominis Plane Block guided by ultrasound device using bupivacaine (Marcaine, 0.25%), 0.5 ml/kg on each side.; Other Names: Plain marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain score	Children's Hospital Eastern Ontario Pain Scale	12 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total intraoperative fentanyl consumption	Microgram (ug)	12 hours postoperative
number of participants with incidence of nausea	number of patients	12 hours postoperative
number of participants with incidence of hematoma	number of patients	12 hours postoperative
number of participants with incidence of infection	number of patients	12 hours postoperative
Total postoperative paracetamol consumption	Milligram (mg)	12 hours postoperative
Number of participants with incidence of vomiting	number of patients	12 hours postoperative

Collaborators and Investigators

• Sponsor: Abdelrady S Ibrahim, MD
• Investigators: Principal Investigator: Abdelrady s Ibrahim, MD, Assistant profossor

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: March 14, 2016
• First Submitted That Met QC Criteria: March 29, 2016
• First Posted (Estimate): March 30, 2016

Study Record Updates

• Last Update Posted (Actual): December 8, 2017
• Last Update Submitted That Met QC Criteria: December 6, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: pediatric; Laparoscopic; postoperative pain; TAP block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 17100390

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided