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Transversus Abdominis Plane Block for Pain Relieve in Children Undergoing Groin Surgery (TAP)

Primary Purpose

Postoperative Pain, Reaction; Anesthesia

Status
Terminated
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Bupivacain/levobupivacaine
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring measure of postoperative pain, children undergoing groin surgery

Eligibility Criteria

2 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female children aged 2 - 8 years
  • physical status classification system (ASA) score I or II
  • Undergoing surgical interventions in the groin (hernia repair, funiculocele ectomy)

Exclusion Criteria:

  • Hypersensitivity to Levobupivacaine

Sites / Locations

  • University Childrens Hospital of both Basel

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

transversus abdominal plane block

Arm Description

Caudal block: Identification of the epidural space with a loss of resistance technique. Administration of Bupivacain 1ml/kg 0.125%. Transversus abdominal plane block: Identification of the anatomical structures with ultrasound, insertion of the stimuplex needle G22, 50mm, in an in-plane approach and administration of 0.4ml/kg levobupivacaine 0.25%.

Outcomes

Primary Outcome Measures

Efficacy of the postoperative analgesia: monitoring with KUSS or Smiley scale.

Secondary Outcome Measures

Full Information

First Posted
August 25, 2009
Last Updated
December 2, 2015
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT00970086
Brief Title
Transversus Abdominis Plane Block for Pain Relieve in Children Undergoing Groin Surgery
Acronym
TAP
Official Title
Transversus Abdominis Plane Block for Pain Relieve in Children Undergoing Inguinal Surgical Procedures: How Does it Compare With the "Gold Standard" Caudal Blockade
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
Groin surgery was changed to a laparoscopic technique; recruitable patients ceased.
Study Start Date
August 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
For surgery in the region of the lower abdominal wall the administration of local anesthetic drugs in the epidural space via the caudal route is the preferentially used technique since several decades. The transversus abdominis plane (TAP) block features the advantages of a peripheral nerve blockade. The aim of this study is to evaluate potential differences in the effectiveness of postoperative analgesia and to test the hypotheses that the duration of pain relieve ist prolonged after a TAP block when compared with an epidural technique.
Detailed Description
Caudal block (CB) is the gold standard technique for analgesia in children undergoing surgical interventions in the groin. Although the efficacy and the safety of this technique is high, nonetheless, there are several caveats such as unwarranted motor blockade of the lower limbs and disturbances of the bladder function, potentially resulting in delayed demission in the ambulatory setting. The effect of the blockade wears off within 4-5h post-block, making the administration of additional pain medication necessary. Peripheral nerve blockades (PNB) are an alternative to CB and have a prolonged duration of the analgesic effect. More recently, an alternative method to block neural structures which innervate lower abdominal wall has been described; the transverse abdominal plane block. The ultrasound guided technique improves the safety of margin. However, although this new technique seems to offer substantial advantages so far only experience from small case series are available. In particular, the TAP block has not been compared in a systematic trial with the "gold standard", the caudal block.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Reaction; Anesthesia
Keywords
measure of postoperative pain, children undergoing groin surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare Provider
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
transversus abdominal plane block
Arm Type
Experimental
Arm Description
Caudal block: Identification of the epidural space with a loss of resistance technique. Administration of Bupivacain 1ml/kg 0.125%. Transversus abdominal plane block: Identification of the anatomical structures with ultrasound, insertion of the stimuplex needle G22, 50mm, in an in-plane approach and administration of 0.4ml/kg levobupivacaine 0.25%.
Intervention Type
Drug
Intervention Name(s)
Bupivacain/levobupivacaine
Intervention Description
Caudal block: Identification of the epidural space with a loss of resistance technique. Administration of Bupivacain 1ml/kg 0.125%. Transversus abdominal plane block: Identification of the anatomical structures by the ultrasound technique, administration of 0.4ml/kg levobupivacaine 0.25%.
Primary Outcome Measure Information:
Title
Efficacy of the postoperative analgesia: monitoring with KUSS or Smiley scale.
Time Frame
4 h postoperative and morning, 1 day postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female children aged 2 - 8 years physical status classification system (ASA) score I or II Undergoing surgical interventions in the groin (hernia repair, funiculocele ectomy) Exclusion Criteria: Hypersensitivity to Levobupivacaine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Erb, PD
Organizational Affiliation
University Childrens Hospital of both Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Childrens Hospital of both Basel
City
Basel
ZIP/Postal Code
4005
Country
Switzerland

12. IPD Sharing Statement

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Transversus Abdominis Plane Block for Pain Relieve in Children Undergoing Groin Surgery

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