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

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ClinicalTrials.gov Identifier: NCT00970086
Recruitment Status : Terminated (Groin surgery was changed to a laparoscopic technique; recruitable patients ceased.)
First Posted : September 2, 2009
Last Update Posted : December 3, 2015
Sponsor:
Information provided by (Responsible Party):
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.


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

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
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
Study Start Date : August 2009
Primary Completion Date : November 2010
Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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%.




Primary Outcome Measures :
  1. Efficacy of the postoperative analgesia: monitoring with KUSS or Smiley scale. [ Time Frame: 4 h postoperative and morning, 1 day postoperative ]


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Ages Eligible for Study:   2 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00970086


Locations
Switzerland
University Childrens Hospital of both Basel
Basel, Switzerland, 4005
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Thomas Erb, PD University Childrens Hospital of both Basel

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00970086     History of Changes
Other Study ID Numbers: UKBB_ANA_TAP
First Posted: September 2, 2009    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015

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

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Bupivacaine
Levobupivacaine
Acetaminophen
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Analgesics
Antipyretics