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Surgical Transversus Abdominis Plane Block in Pediatric Patients

NCT ID: NCT01548027

Last Updated: 2014-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Child

Keywords

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TAP block postoperative analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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No intervention

no injection of local anesthetic agents

Group Type EXPERIMENTAL

No intervention

Intervention Type OTHER

No intervention

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.

Group Type EXPERIMENTAL

Local infiltration group

Intervention Type PROCEDURE

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 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

Group Type EXPERIMENTAL

TAP block

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type 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

Intervention Type PROCEDURE

No intervention

No intervention

Intervention Type OTHER

Other Intervention Names

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local anesthetic infiltration surgical transversus abdominis plane block

Eligibility Criteria

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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
Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Saowaphak Lapmahapaisan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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752/2554

Identifier Type: -

Identifier Source: org_study_id