Transversus Abdominis Plane Block in Children Undergoing Ostomy Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01136668|
Recruitment Status : Terminated (Unable to recruit adequate number of subjects)
First Posted : June 3, 2010
Last Update Posted : April 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Anesthesia Ostomy||Procedure: Transversus Abdominis Plane Block Procedure: Standard||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Transversus Abdominis Plane Block in Children Undergoing Ostomy Surgery: A Prospective Randomized Controlled Trial|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
|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.
- Morphine Requirement [ Time Frame: within the first 48 hours after surgery ]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 ]
- Pain scores [ Time Frame: within the first 48 hours after surgery ]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 ]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 ]
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): NCT01136668
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Jason Hayes, MD||The Hospital for Sick Children, Toronto Canada|