Clinical Trials Directory

Trials / Terminated

TerminatedNCT01136668

Transversus Abdominis Plane Block in Children Undergoing Ostomy Surgery

Transversus Abdominis Plane Block in Children Undergoing Ostomy Surgery: A Prospective Randomized Controlled Trial

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
13 (actual)
Sponsor
The Hospital for Sick Children · Academic / Other
Sex
All
Age
3 Months – 18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURETransversus Abdominis Plane BlockA 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.
PROCEDUREStandardCircumferential 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.

Timeline

Start date
2010-04-01
Primary completion
2012-05-01
Completion
2012-05-01
First posted
2010-06-03
Last updated
2021-06-08
Results posted
2021-06-08

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT01136668. Inclusion in this directory is not an endorsement.