Transversus Abdominis Plane Block in Children Undergoing Ostomy Surgery
The primary objective of this study is to determine if the use of Transversus Abdominis Plane (TAP) blocks reduce early postoperative opioid requirements.
Procedure: Transversus Abdominis Plane Block
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Transversus Abdominis Plane Block in Children Undergoing Ostomy Surgery: A Prospective Randomized Controlled Trial|
- Morphine Requirement [ Time Frame: within the first 48 hours after surgery ] [ Designated as safety issue: No ]The primary endpoint will be the proportion of children in each group requiring two or more (≥ 2) boluses of morphine in the PACU.
- Dose of opioids administered [ Time Frame: within the first 48 hours after surgery ] [ Designated as safety issue: No ]
- Pain scores [ Time Frame: within the first 48 hours after surgery ] [ Designated as safety issue: No ]Pain scores will be assessed using the Faces-Legs-Activity-Cry-Consolibility (FLACC) scale for children ≤ 7 years old (Appendix 2 of Protocol) and the Numerical Rating Scale (NRS) for children > 7 years old. Pain scores will be determined by agreement between the PACU nurse and Anesthesia Clinical Research Nurse, both of whom will be blinded to the group allocation. 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 opioid-related side effects [ Time Frame: within the first 48 hours after surgery ] [ Designated as safety issue: Yes ]A study investigator or research nurse will assess the patient (from both groups to maintain blinding) each day during the hospital admission for signs of adverse events related to the TAP block, such as persistent pain or redness, swelling, and/or discharge from the puncture site.
- Time to tolerance of oral intake [ Time Frame: within the first 48 hours after surgery ] [ Designated as safety issue: No ]
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
|Experimental: Treatment group||
Procedure: Transversus Abdominis Plane Block
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.
|Active Comparator: Control Group||
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01136668
|Contact: Carolyne Pehora||416-813-7654 ext firstname.lastname@example.org|
|The Hospital for Sick Children||Recruiting|
|Toronto, Ontario, Canada, M5G 1X8|
|Contact: Carolyne Pehora 416 813 7654 ext 2406 email@example.com|
|Principal Investigator: Jason Hayes, MD|
|Sub-Investigator: Damian Simpson, MD|
|Sub-Investigator: Joost de Ruiter, MD|
|Sub-Investigator: Gail Wong, MD|
|Sub-Investigator: Paul Wales, MD|
|Sub-Investigator: Mark Crawford, MD|
|Principal Investigator:||Jason Hayes, MD||The Hospital for Sick Children, Toronto Canada|