ClinicalTrials.Veeva

Menu

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

University Hospital Basel logo

University Hospital Basel

Status and phase

Terminated
Phase 4

Conditions

Postoperative Pain
Reaction; Anesthesia

Treatments

Drug: Bupivacain/levobupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT00970086
UKBB_ANA_TAP

Details and patient eligibility

About

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.

Full 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.

Enrollment

22 patients

Sex

All

Ages

2 to 8 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

Double Blind

22 participants in 1 patient group

transversus abdominal plane block
Experimental group
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%.
Treatment:
Drug: Bupivacain/levobupivacaine

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems