Ultrasound Guided Transversus Abdominis Plane Block in Pediatric Surgery

December 6, 2017 updated by: Abdelrady S Ibrahim, MD

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut University Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 12 hours postoperative
Children's Hospital Eastern Ontario Pain Scale
12 hours postoperative

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abdelrady S Ibrahim, MD

Investigators

  • Principal Investigator: Abdelrady s Ibrahim, MD, Assistant profossor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17100390

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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