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

This study has been terminated.
(Groin surgery was changed to a laparoscopic technique; recruitable patients ceased.)
Sponsor:
Information provided by (Responsible Party):
Thomas Erb, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00970086
First received: August 25, 2009
Last updated: December 20, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Postoperative Pain
Reaction; Anesthesia
Drug: Bupivacain/levobupivacaine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Efficacy of the postoperative analgesia: monitoring with KUSS or Smiley scale. [ Time Frame: 4 h postoperative and morning, 1 day postoperative ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: August 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: transversus abdominal plane block

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%.

Drug: Bupivacain/levobupivacaine

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%.


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.

  Eligibility

Ages Eligible for Study:   2 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Hypersensitivity to Levobupivacaine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00970086

Locations
Switzerland
University Hospital for children beider Basel
Basel, Switzerland, 4005
Sponsors and Collaborators
Thomas Erb
Investigators
Principal Investigator: Thomas Erb, PD University Childrens Hospital beider Basel
  More Information

No publications provided

Responsible Party: Thomas Erb, Prof. Dr.Thomas Erb, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00970086     History of Changes
Other Study ID Numbers: UKBB_ANA_TAP
Study First Received: August 25, 2009
Last Updated: December 20, 2011
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:
measure of postoperative pain
children undergoing groin surgery

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Bupivacaine
Levobupivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014