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

Phase 4

Terminated

• Conditions: Postoperative Pain; Reaction; Anesthesia
• Interventions: Drug: Bupivacain/levobupivacaine

• Registration Number: NCT00970086
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-25
• Study First Submitted QC: 2009-09-01
• Study First Posted: 2009-09-02
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-02
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
transversus abdominal plane block	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 with ultrasound, insertion of the stimuplex needle G22, 50mm, in an in-plane approach and administration of 0.4ml/kg levobupivacaine 0.25%.

Primary Outcome Measures

Name	Time	Method
Efficacy of the postoperative analgesia: monitoring with KUSS or Smiley scale.	4 h postoperative and morning, 1 day postoperative

Trial Locations

Locations (1)

University Childrens Hospital of both Basel; 🇨🇭 Basel, Switzerland