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

August 25, 2009
December 20, 2011
August 2009
November 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00970086 on ClinicalTrials.gov Archive Site
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Transversus Abdominis Plane Block for Pain Relieve in Children Undergoing Groin Surgery
Transversus Abdominis Plane Block for Pain Relieve in Children Undergoing Inguinal Surgical Procedures: How Does it Compare With the "Gold Standard" Caudal Blockade

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.

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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
  • Postoperative Pain
  • Reaction; Anesthesia
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%.

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%.

Intervention: Drug: Bupivacain/levobupivacaine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
22
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
2 Years to 8 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00970086
UKBB_ANA_TAP
No
Thomas Erb, University Hospital, Basel, Switzerland
Thomas Erb
Not Provided
Principal Investigator: Thomas Erb, PD University Childrens Hospital beider Basel
University Hospital, Basel, Switzerland
December 2011

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