Transversus Abdominis Plane Block in Children Undergoing Ostomy Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anesthesia, Ostomy

Intervention / Treatment
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* Procedure: Transversus Abdominis Plane Block
* Procedure: Standard


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children undergoing revision or closure of ostomy American Society of Anesthesiologists Classification 1-3. age ≥ 3 months Exclusion Criteria: children undergoing an additional surgical procedure (e.g. circumcision) at an anatomical location not covered by a one-sided/ unilateral TAP block, during the same anesthetic children in whom a TAP block is contraindicated, i.e. surgical scar or distorted anatomy at the site of injection postoperative admission to the intensive care unit children with a known allergy to bupivacaine children with a history of chronic abdominal pain use of opioid analgesics prior to surgery pregnancy impaired renal function impaired hepatic function known impaired cardiac function hypersensitivity to sodium metabisulfite

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Bupivacine-TAP block | Procedure: Transversus Abdominis Plane Block<br>* A 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.<br>|
| Active Comparator: Control Group<br>Bupivacaine- wound infiltration | Procedure: Standard<br>* Circumferential 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine Requirement | The primary endpoint will be the proportion of children in each group requiring two or more (≥ 2) boluses of morphine in the PACU. | within the first 48 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatrics, Transversus Abdominis Plane Block, Ostomy Surgery, Anesthesia, Regional Anesthetic