Surgical Transversus Abdominis Plane Block in Pediatric Patients (TAP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Mahidol University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Mahidol University
ClinicalTrials.gov Identifier:
NCT01548027
First received: March 5, 2012
Last updated: July 4, 2012
Last verified: July 2012

March 5, 2012
July 4, 2012
March 2012
December 2013   (final data collection date for primary outcome measure)
opioids consumption [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
total opioids consumption in first 24 hours postoperatively
Same as current
Complete list of historical versions of study NCT01548027 on ClinicalTrials.gov Archive Site
Time to first analgesic [ Time Frame: 24 hr ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Surgical Transversus Abdominis Plane Block in Pediatric Patients
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Child
  • 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
  • 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
  • No Intervention: control group
    no injection of local anesthetic agents
  • Experimental: Local infiltration group
    Intervention: Procedure: Local infiltration group
  • Experimental: TAP block group
    Intervention: Procedure: TAP block
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
54
April 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
up to 15 Years
Yes
Contact: Saowaphak Lapmahapaisan, M.D. 662-4197995 sislg@mahidol.ac.th
Thailand
 
NCT01548027
752/2554
Yes
Mahidol University
Mahidol University
Not Provided
Principal Investigator: Saowaphak Lapmahapaisan, M.D. Mahidol University
Mahidol University
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP