Transversus Abdominis Plane Block in Children Undergoing Open Pyeloplasty Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by The Hospital for Sick Children
Sponsor:
Information provided by (Responsible Party):
Jason Hayes, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01243593
First received: November 17, 2010
Last updated: August 20, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Anesthesia
Procedure: Transversus Abdominis Plane Block
Procedure: Standard Anesthesia
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transversus Abdominis Plane Block in Children Undergoing Open Pyeloplasty Surgery

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Requirement for morphine post-surgery. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    The primary outcome measure will be the proportion of children in the treatment and control groups requiring a dose of morphine.


Secondary Outcome Measures:
  • Amount of morphine administered post-surgery [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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 pain scores post-surgery [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Pain scores will be assessed using the Faces-Legs-Activity-Cry-Consolibility (FLACC) scale for children ≤ 7 years old. Pain scores will be assessed at admission (time = 0, 5, 10, 15, 30), and then every 15 minutes thereafter until discharge from PACU.

  • Incidence of morphine-related side effects post-surgery [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Side effects of morphine include nausea or vomiting, respiratory depression, pruritus, over-sedation and delayed transition to oral intake.


Estimated Enrollment: 84
Study Start Date: November 2010
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Group Procedure: Transversus Abdominis Plane Block
A block needle will be advanced in a medial to lateral direction until the tip is visualized in the transversus abdominis plane. After negative aspiration 0.4 ml/kg of bupivacaine 0.25% with 1:200 000 epinephrine will be injected. The total dose of bupivacaine will not exceed 2 mg/kg and the total volume will not be more than 20 ml.
Active Comparator: Control Group Procedure: Standard Anesthesia
Local field infiltration with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg before skin incision.

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.

  Eligibility

Ages Eligible for Study:   1 Month to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243593

Contacts
Contact: Carolyne Pehora 416-813-7654 ext 2406 carolyne.pehora@sickkids.ca

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Carolyne Pehora    416 813 7654 ext 2406    carolyne.pehora@sickkids.ca   
Principal Investigator: Jason Hayes, MD         
Sub-Investigator: Johanne Lynch, MD         
Sub-Investigator: Clyde Matava, MD         
Sub-Investigator: Armando Lorenzo, MD         
Sub-Investigator: Gail Wong, MD         
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Jason Hayes, MD The Hospital for Sick Children, Toronto Canada
  More Information

No publications provided

Responsible Party: Jason Hayes, Staff Anesthesiologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01243593     History of Changes
Other Study ID Numbers: 1000019942
Study First Received: November 17, 2010
Last Updated: August 20, 2013
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
pediatrics
anesthesia
pyeloplasty
Transversus Abdominis Plane Block
Regional Anesthesia

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014