Transversus Abdominis Plane Block in Children Undergoing Open Pyeloplasty Surgery
|ClinicalTrials.gov Identifier: NCT01243593|
Recruitment Status : Completed
First Posted : November 18, 2010
Last Update Posted : June 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Anesthesia||Procedure: Transversus Abdominis Plane Block Procedure: Standard Anesthesia||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Transversus Abdominis Plane Block in Children Undergoing Open Pyeloplasty Surgery|
|Study Start Date :||November 2010|
|Primary Completion Date :||November 2014|
|Study Completion Date :||November 2014|
|Experimental: Treatment Group||
Procedure: Transversus Abdominis Plane Block
A 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.
|Active Comparator: Control Group||
Procedure: Standard Anesthesia
Local field infiltration with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg before skin incision.
- Requirement for morphine post-surgery. [ Time Frame: 24 hours ]The primary outcome measure will be the proportion of children in the treatment and control groups requiring a dose of morphine.
- Amount of morphine administered post-surgery [ Time Frame: 24 hours ]Patients will receive intravenous morphine 0.05 mg/kg if the FLACC is ≥ 3/10 (equivalent to mild-to-moderate pain). Morphine may be given at 10 minute intervals as per standard protocol until the FLACC score is < 3/10, or the child declines additional pain medicine when offered.
- Assessment of pain scores post-surgery [ Time Frame: 24 hours ]Pain scores will be assessed using the Faces-Legs-Activity-Cry-Consolibility (FLACC) scale for children ≤ 7 years old. 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 morphine-related side effects post-surgery [ Time Frame: 24 hours ]Side effects of morphine include nausea or vomiting, respiratory depression, pruritus, over-sedation and delayed transition to oral intake.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01243593
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Jason Hayes, MD||The Hospital for Sick Children, Toronto Canada|