Transversus Abdominis Plane Block in Children Undergoing Ostomy Surgery

NCT01136668 | Terminated Results DMC

• 1 other identifier: 1000014754
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to determine if the use of Transversus Abdominis Plane (TAP) blocks reduce early postoperative opioid requirements.

Conditions

Anesthesia; Ostomy

Keywords

pediatrics; Transversus Abdominis Plane Block; Ostomy Surgery; Anesthesia; Regional Anesthetic

Outcome Measures

Primary Outcomes (1)

• Morphine Requirement

  The primary endpoint will be the proportion of children in each group requiring two or more (≥ 2) boluses of morphine in the PACU.

  within the first 48 hours after surgery

Study Arms (2)

Treatment group

EXPERIMENTAL

Bupivacine-TAP block

Procedure: Transversus Abdominis Plane Block

Control Group

ACTIVE COMPARATOR

Bupivacaine- wound infiltration

Procedure: Standard

Interventions

Transversus Abdominis Plane Block PROCEDURE

A high frequency (5-10 mHz) ultrasound probe (Sonosite Micromaxx, Licence No 12407) will be placed on the flank at the midpoint between the iliac crest and lower costal margin. The three muscle layers of external oblique, internal oblique, and transversus abdominis will be visualized. A 22G short-bevel block needle will be advanced in an anterior-to-posterior direction, in-plane with the probe, 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 PROCEDURE

Circumferential subcutaneous infiltration of the ostomy wound with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg by the surgeon after skin closure.

Control Group

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• children undergoing revision or closure of ostomy
• American Society of Anesthesiologists Classification 1-3.
• age ≥ 3 months

You may not qualify if:

• children undergoing an additional surgical procedure (e.g. circumcision) at an anatomical location not covered by a one-sided/ 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
• use of opioid analgesics prior to surgery
• pregnancy
• impaired renal function
• impaired hepatic function
• known impaired cardiac function
• hypersensitivity to sodium metabisulfite

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Results Point of Contact

• Title: Dr. Jason Hayes
• Organization: Hospital for Sick Children

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, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist

Study Record Dates

• First Submitted: June 2, 2010
• First Posted: June 3, 2010
• Study Start: April 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: June 8, 2021
• Results First Posted: June 8, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)