Surgical Transversus Abdominis Plane Block in Pediatric Patients (TAP)

July 30, 2014 updated by: Mahidol University

Efficacy of Surgical Transversus Abdominis Plane Block for Postoperative Pain Relief Following Abdominal Surgery in Pediatric Patients.

The objective of this study to determine the effect of surgical transversus abdominis plane block and local infiltration for postoperative pain control in major abdominal surgery compare with control group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Most children experience postoperative pain after major abdominal surgery. They may have ineffective ventilation, following atelectasis and pneumonia if receive inadequate pain management. There are several methods used for pain relief such as epidural block, intravenous analgesia with local infiltration, transversus abdominis plane (TAP) block by ultrasound guided and surgical TAP block. Therefore, the investigators would like to compare the effectiveness of postoperative pain control with TAP block. However, TAP block in children need experience and ultrasound. The investigators decided to do surgical TAP block performing by inject from peritoneum point to skin instead.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

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

  • Thailand
      • Bangkok, Thailand, 10700
        • Faculty of Medicine, Siriraj Hospital, Mahidol University

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

No older than 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age < 15 year
  2. ASA I-III
  3. Abdominal surgery : all upper abdomen and lower abdomen which would have midline incision
  4. Elective surgery

Exclusion Criteria:

  1. Allergic to Lidocaine or bupivacaine
  2. Delayed development
  3. Major abdominal surgery within 2 year

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: No intervention
no injection of local anesthetic agents
Other: No intervention
No intervention
Experimental: Local infiltration group
patients would have 0.5 ml/kg of 0.25% bupivacaine if age < 6 months or 1 ml/kg if age > 6 months around the wound by surgeon. The needle will be injected in subcutaneous tissue parallel to the wound.
Procedure: Local infiltration group
patients would have 0.5 ml/kg of 0.25% bupivacaine if age < 6 months or 1 ml/kg if age > 6 months around the wound by surgeon. The needle will be injected in subcutaneous tissue parallel to the wound.
Other Names:
  • local anesthetic infiltration
Experimental: TAP block group
Surgical TAP block (sTAP: Patients would have 0.5 ml/kg of 0.25% bupivacaine if age < 6 months or 1 ml/kg if age > 6 months
Procedure: TAP block
Surgical TAP block (sTAP: Patients would have 0.5 ml/kg of 0.25% bupivacaine if age < 6 months or 1 ml/kg if age > 6 months
Other Names:
  • surgical transversus abdominis plane block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
opioids consumption
Time Frame: 24 hours
total opioids consumption in first 24 hours postoperatively
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to first analgesic
Time Frame: 24 hr
24 hr

Collaborators and Investigators

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

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Saowaphak Lapmahapaisan, M.D., Mahidol University

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

July 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

March 5, 2012

First Submitted That Met QC Criteria

March 7, 2012

First Posted (Estimate)

March 8, 2012

Study Record Updates

Last Update Posted (Estimate)

July 31, 2014

Last Update Submitted That Met QC Criteria

July 30, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 752/2554

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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