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Surgical Transversus Abdominis Plane Block in Pediatric Patients (TAP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01548027
First Posted: March 8, 2012
Last Update Posted: July 31, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mahidol University
  Purpose
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.

Condition Intervention
Child Procedure: Local infiltration group Procedure: TAP block Other: No intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Surgical Transversus Abdominis Plane Block for Postoperative Pain Relief Following Abdominal Surgery in Pediatric Patients.

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • opioids consumption [ Time Frame: 24 hours ]
    total opioids consumption in first 24 hours postoperatively


Secondary Outcome Measures:
  • Time to first analgesic [ Time Frame: 24 hr ]

Enrollment: 54
Study Start Date: July 2012
Study Completion Date: July 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: surgical transversus abdominis plane block

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01548027


Locations
Thailand
Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Saowaphak Lapmahapaisan, M.D. Mahidol University
  More Information

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01548027     History of Changes
Other Study ID Numbers: 752/2554
First Submitted: March 5, 2012
First Posted: March 8, 2012
Last Update Posted: July 31, 2014
Last Verified: July 2014

Keywords provided by Mahidol University:
TAP block
postoperative analgesia

Additional relevant MeSH terms:
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents