Transversus Abdominis Plane Block in Children Undergoing Ostomy Surgery

Not Applicable

Terminated

• Conditions: Ostomy; Anesthesia
• Interventions: Procedure: Standard; Procedure: Transversus Abdominis Plane Block

• Registration Number: NCT01136668
• Lead Sponsor: The Hospital for Sick Children

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.

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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-06-02
• Study First Submitted QC: 2010-06-02
• Study First Posted: 2010-06-03
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Results First Submitted: 2018-04-17
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-12
• Last Update Submitted: 2021-05-12
• Results First Posted: 2021-06-08
• Last Update Posted: 2021-06-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Standard	Bupivacaine- wound infiltration
Treatment group	Transversus Abdominis Plane Block	Bupivacine-TAP block

Primary Outcome Measures

Name	Time	Method
Morphine Requirement	within the first 48 hours after surgery	The primary endpoint will be the proportion of children in each group requiring two or more (≥ 2) boluses of morphine in the PACU.

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada