Transversus Abdominis Plane Block in Children Undergoing Open Pyeloplasty Surgery
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|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|
|Actual Primary Completion Date :||November 2014|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|