Transversus Abdominis Plane Block in Children Undergoing Ostomy Surgery

The Hospital for Sick Children

Status: Terminated

Conditions: Ostomy; Anesthesia

Treatments: Procedure: Standard; Procedure: Transversus Abdominis Plane Block

Study type: Interventional

Funder types: Other

Identifiers

NCT01136668

1000014754

Details and patient eligibility

About

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

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 3 months to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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13 participants in 2 patient groups

Treatment group

Experimental group

Description:

Bupivacine-TAP block

Treatment:

Procedure: Transversus Abdominis Plane Block

Control Group

Active Comparator group

Description:

Bupivacaine- wound infiltration

Treatment:

Procedure: Standard