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Transversus Abdominis Plane Block in Children Undergoing Open Pyeloplasty Surgery

T

The Hospital for Sick Children

Status

Completed

Conditions

Anesthesia

Treatments

Procedure: Standard Anesthesia
Procedure: Transversus Abdominis Plane Block

Study type

Interventional

Funder types

Other

Identifiers

NCT01243593
1000019942

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness of transversus abdominis plane (TAP) block in reducing postoperative opioid requirements and pain after open pyeloplasty surgery in children.

Full description

Primary open pyeloplasty is a common elective surgical procedure at The Hospital for Sick Children. All children are given fentanyl plus local anesthetic wound infiltration for intraoperative analgesia. A retrospective audit demonstrated that 63% of children required additional opioid treatment in the early recovery period following surgery. Concern exists regarding potential side effects of opioids including nausea or vomiting, respiratory depression, pruritus, over-sedation and delayed transition to oral intake. More importantly, children may under-report their pain or pain may not be recognized by medical staff leading to inadequate provision of analgesia. This suggests that the use of a regional technique, such as a TAP block, may benefit children undergoing open pyeloplasty.

The ultrasound guided TAP block introduces a local anaesthetic to the transversus abdominis plane which is one of three muscle layers in the abdominal wall. This results in a block of the nerves leading to the abdominal wall thereby reducing pain sensations.

Enrollment

32 patients

Sex

All

Ages

1 month to 6 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • American Society of Anesthesiologists (ASA) classification score 1-3
  • age 1 month to 6 years inclusive

Exclusion criteria

  • children undergoing an additional surgical procedure at an anatomical location not covered by a unilateral TAP block during the same anesthetic
  • children in whom a TAP block is contraindicated, i.e. surgical scar or distorted anatomy at the site of injection
  • postoperative admission to the intensive care unit
  • children with a known allergy to bupivacaine
  • children with a history of chronic abdominal pain requiring opioid analgesics
  • children with known renal insufficiency
  • children with known impaired hepatic function
  • children with known impaired cardiac function
  • children known hypersensitivity to sodium metabisulfite

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

32 participants in 2 patient groups

Treatment Group
Experimental group
Treatment:
Procedure: Transversus Abdominis Plane Block
Control Group
Active Comparator group
Treatment:
Procedure: Standard Anesthesia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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