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Clinical Trials/NCT00970086
NCT00970086
Terminated
Phase 4

Transversus Abdominis Plane Block for Pain Relieve in Children Undergoing Inguinal Surgical Procedures: How Does it Compare With the "Gold Standard" Caudal Blockade

University Hospital, Basel, Switzerland1 site in 1 country22 target enrollmentAugust 2009

Overview

Phase
Phase 4
Intervention
Bupivacain/levobupivacaine
Conditions
Postoperative Pain
Sponsor
University Hospital, Basel, Switzerland
Enrollment
22
Locations
1
Primary Endpoint
Efficacy of the postoperative analgesia: monitoring with KUSS or Smiley scale.
Status
Terminated
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2009
End Date
November 2010
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital, Basel, Switzerland
Responsible Party
Sponsor

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

Arms & Interventions

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: Bupivacain/levobupivacaine

Outcomes

Primary Outcomes

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

Time Frame: 4 h postoperative and morning, 1 day postoperative

Study Sites (1)

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