NCT01243593

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2010

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
6.3 years until next milestone

Results Posted

Study results publicly available

February 4, 2021

Completed
Last Updated

February 4, 2021

Status Verified

February 1, 2021

Enrollment Period

4 years

First QC Date

November 17, 2010

Results QC Date

October 25, 2017

Last Update Submit

February 3, 2021

Conditions

Anesthesia

Keywords

pediatricsanesthesiapyeloplastyTransversus Abdominis Plane BlockRegional Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Requirement for Morphine Post-surgery.

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

    Time in recovery room, approximately 60-90 minutes.

Secondary Outcomes (2)

  • Total Amount of Morphine (mg/kg) Administered in the Recovery Room.

    Time in recovery room, approximately 60-90 minutes.

  • Assessment of First Pain Score on Arrival to Recovery Room.

    On arrival to recovery room.

Study Arms (2)

Treatment Group

EXPERIMENTAL
Procedure: Transversus Abdominis Plane Block

Control Group

ACTIVE COMPARATOR
Procedure: Standard Anesthesia

Interventions

Transversus Abdominis Plane BlockPROCEDURE

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.

Treatment Group
Standard AnesthesiaPROCEDURE

Local field infiltration with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg before skin incision.

Control Group

Eligibility Criteria

Age1 Month - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

  • Lorenzo AJ, Lynch J, Matava C, El-Beheiry H, Hayes J. Ultrasound guided transversus abdominis plane vs surgeon administered intraoperative regional field infiltration with bupivacaine for early postoperative pain control in children undergoing open pyeloplasty. J Urol. 2014 Jul;192(1):207-13. doi: 10.1016/j.juro.2014.01.026. Epub 2014 Feb 8.

    PMID: 24518763RESULT

Results Point of Contact

Title
Dr. Jason Hayes
Organization
Sick Kids Hospital
jason.hayes@sickkids.ca
416-813-7445

Study Officials

  • Jason Hayes, MD

    The Hospital for Sick Children, Toronto Canada

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Anesthesiologist

Study Record Dates

First Submitted

November 17, 2010

First Posted

November 18, 2010

Study Start

November 1, 2010

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

February 4, 2021

Results First Posted

February 4, 2021

Record last verified: 2021-02

Locations

CA(1)