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Transversus Abdominis Plane Block in Children Undergoing Open Pyeloplasty Surgery

Not Applicable
Completed
Conditions
Anesthesia
Interventions
Procedure: Transversus Abdominis Plane Block
Procedure: Standard Anesthesia
Registration Number
NCT01243593
Lead Sponsor
The Hospital for Sick Children
Brief Summary

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.

Detailed 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
32
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Treatment GroupTransversus Abdominis Plane Block-
Control GroupStandard Anesthesia-
Primary Outcome Measures
NameTimeMethod
Requirement for Morphine Post-surgery.Time in recovery room, approximately 60-90 minutes.

The primary outcome measure will be the count and percentage of children who require morphine in the recovery room.

Secondary Outcome Measures
NameTimeMethod
Total Amount of Morphine (mg/kg) Administered in the Recovery Room.Time in recovery room, approximately 60-90 minutes.

Patients will receive intravenous morphine 0.05 mg/kg if the FLACC is ≥ 3/10 (equivalent to mild-to-moderate pain). Morphine may be given at 10 minute intervals as per standard protocol until the FLACC score is \< 3/10, or the child declines additional pain medicine when offered.

Assessment of First Pain Score on Arrival to Recovery Room.On arrival to recovery room.

Pain scores will be assessed using the Faces-Legs-Activity-Cry-Consolibility (FLACC) scale for children ≤ 7 years old. The FLACC scale is from 0-10 (0=no pain, 10=worst pain). The scale is composed of five subscales (Faces = facial expression; Legs = lower extremity movement; Activity = degree of movement; Cry = how upset the child is; Consolibity = how easy the child can be consoled). Eacg subscale is rated 0 to 2 (0 = rated as comfortable, no or minimal discomfort for that subscale; 2 = rated as uncomfortable, in pain according to that subscale). The subscales are summed to give a composite score out of 10. Pain scores will be assessed at admission to the recovery room.

Trial Locations

Locations (1)

The Hospital for Sick Children

🇨🇦

Toronto, Ontario, Canada

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