Clinical Trials Directory

Trials / Completed

CompletedNCT01243593

Transversus Abdominis Plane Block in Children Undergoing Open Pyeloplasty Surgery

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
32 (actual)
Sponsor
The Hospital for Sick Children · Academic / Other
Sex
All
Age
1 Month – 6 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to evaluate the effectiveness of transversus abdominis plane (TAP) block in reducing postoperative opioid requirements and pain after open pyeloplasty surgery in children.

Detailed description

Primary open pyeloplasty is a common elective surgical procedure at The Hospital for Sick Children. All children are given fentanyl plus local anesthetic wound infiltration for intraoperative analgesia. A retrospective audit demonstrated that 63% of children required additional opioid treatment in the early recovery period following surgery. Concern exists regarding potential side effects of opioids including nausea or vomiting, respiratory depression, pruritus, over-sedation and delayed transition to oral intake. More importantly, 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, such as a TAP block, may benefit children undergoing open pyeloplasty. The ultrasound guided TAP block introduces a local anaesthetic to the transversus abdominis plane which is one of three muscle layers in the abdominal wall. This results in a block of the nerves leading to the abdominal wall thereby reducing pain sensations.

Conditions

Interventions

TypeNameDescription
PROCEDURETransversus Abdominis Plane BlockA block needle will be advanced in a medial to lateral direction 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.
PROCEDUREStandard AnesthesiaLocal field infiltration with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg before skin incision.

Timeline

Start date
2010-11-01
Primary completion
2014-11-01
Completion
2014-11-01
First posted
2010-11-18
Last updated
2021-02-04
Results posted
2021-02-04

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT01243593. Inclusion in this directory is not an endorsement.