Transversus Abdominis Plane Block in Children Undergoing Ostomy 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:
NCT01136668
First received: June 2, 2010
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

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


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

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Morphine Requirement [ Time Frame: within the first 48 hours after surgery ] [ Designated as safety issue: No ]
    The primary endpoint will be the proportion of children in each group requiring two or more (≥ 2) boluses of morphine in the PACU.


Secondary Outcome Measures:
  • Dose of opioids administered [ Time Frame: within the first 48 hours after surgery ] [ Designated as safety issue: No ]
  • Pain scores [ Time Frame: within the first 48 hours after surgery ] [ Designated as safety issue: No ]
    Pain scores will be assessed using the Faces-Legs-Activity-Cry-Consolibility (FLACC) scale for children ≤ 7 years old (Appendix 2 of Protocol) and the Numerical Rating Scale (NRS) for children > 7 years old. Pain scores will be determined by agreement between the PACU nurse and Anesthesia Clinical Research Nurse, both of whom will be blinded to the group allocation. 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 opioid-related side effects [ Time Frame: within the first 48 hours after surgery ] [ Designated as safety issue: Yes ]
    A study investigator or research nurse will assess the patient (from both groups to maintain blinding) each day during the hospital admission for signs of adverse events related to the TAP block, such as persistent pain or redness, swelling, and/or discharge from the puncture site.

  • Time to tolerance of oral intake [ Time Frame: within the first 48 hours after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: April 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment group Procedure: Transversus Abdominis Plane Block
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.
Active Comparator: Control Group Procedure: Standard
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.

Detailed Description:

Revision or closure of ostomy is a common elective surgical procedure at The Hospital for Sick Children. A retrospective audit conducted at SickKids demonstrated significant intraoperative opioid use and significant requirements for rescue opioids in recovery.

Concerns exist regarding the relative merits of opioid use in abdominal surgery. Opioids may decrease bowel motility leading to the increased incidence and duration of postoperative ileus. They may be associated with increased rates of post-operative nausea and vomiting and pruritus. Lastly 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 may benefit children undergoing revision of ostomy.

  Eligibility

Ages Eligible for Study:   3 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  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: NCT01136668

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: Damian Simpson, MD         
Sub-Investigator: Joost de Ruiter, MD         
Sub-Investigator: Gail Wong, MD         
Sub-Investigator: Paul Wales, MD         
Sub-Investigator: Mark Crawford, 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: NCT01136668     History of Changes
Other Study ID Numbers: 1000014754
Study First Received: June 2, 2010
Last Updated: August 19, 2013
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
pediatrics
Transversus Abdominis Plane Block
Ostomy Surgery
Anesthesia
Regional Anesthetic

ClinicalTrials.gov processed this record on October 23, 2014