Surgical Transversus Abdominis Plane Block in Pediatric Patients

Child Clinical Trial

— TAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01548027
• Other study ID #: 752/2554
• Status: Completed
• Phase: N/A
• First received: March 5, 2012
• Last updated: July 30, 2014
• Start date: July 2012
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 15 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Child

Intervention

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.
• 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:
• No intervention
No intervention

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	opioids consumption	total opioids consumption in first 24 hours postoperatively	24 hours	No
Secondary	Time to first analgesic		24 hr	No