Ultrasound Guided Transversus Abdominis Plane Block in Pediatric Surgery

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02723487
• Other study ID #: 17100390
• Status: Completed
• Phase: Phase 2
• First received: March 14, 2016
• Last updated: December 6, 2017
• Start date: April 2016
• Est. completion date: October 2017

Study information

• Verified date: December 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 1 Year to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Assiut university faculty of medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Abdelrady S Ibrahim, MD

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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):395-9. doi: 10.1213/ANE.0000000000000284. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain score	Children's Hospital Eastern Ontario Pain Scale	12 hours postoperative
Secondary	Total intraoperative fentanyl consumption	Microgram (ug)	12 hours postoperative
Secondary	number of participants with incidence of nausea	number of patients	12 hours postoperative
Secondary	number of participants with incidence of hematoma	number of patients	12 hours postoperative
Secondary	number of participants with incidence of infection	number of patients	12 hours postoperative
Secondary	Total postoperative paracetamol consumption	Milligram (mg)	12 hours postoperative
Secondary	Number of participants with incidence of vomiting	number of patients	12 hours postoperative