Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-27 @ 11:50 AM
Study NCT ID:
NCT01136668
Status:
TERMINATED
Last Update Posted:
2021-06-08
First Post:
2010-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Transversus Abdominis Plane Block in Children Undergoing Ostomy Surgery
Sponsor:
The Hospital for Sick Children
Organization:
Study Overview
Official Title:
Transversus Abdominis Plane Block in Children Undergoing Ostomy Surgery: A Prospective Randomized Controlled Trial
Status:
TERMINATED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to recruit adequate number of subjects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: