Transversus Abdominis Plane Block in Children Undergoing Ostomy Surgery

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01136668
• Other study ID #: 1000014754
• Status: Terminated
• Phase: N/A
• Start date: April 2010
• Est. completion date: May 2012

Study information

• Verified date: May 2021
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to determine if the use of Transversus Abdominis Plane (TAP) blocks reduce early postoperative opioid requirements.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Ostomy

Intervention

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.
• Standard
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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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