Transversus Abdominis Plane Block in Children Undergoing Open Pyeloplasty Surgery

Anesthesia Clinical Trial

Official title:

Transversus Abdominis Plane Block in Children Undergoing Open Pyeloplasty Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01243593
• Other study ID #: 1000019942
• Status: Completed
• Phase: N/A
• Start date: November 2010
• Est. completion date: November 2014

Study information

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

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of transversus abdominis plane (TAP) block in reducing postoperative opioid requirements and pain after open pyeloplasty surgery in children.

Description:

Primary open pyeloplasty is a common elective surgical procedure at The Hospital for Sick Children. All children are given fentanyl plus local anesthetic wound infiltration for intraoperative analgesia. A retrospective audit demonstrated that 63% of children required additional opioid treatment in the early recovery period following surgery. Concern exists regarding potential side effects of opioids including nausea or vomiting, respiratory depression, pruritus, over-sedation and delayed transition to oral intake. More importantly, 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, such as a TAP block, may benefit children undergoing open pyeloplasty. The ultrasound guided TAP block introduces a local anaesthetic to the transversus abdominis plane which is one of three muscle layers in the abdominal wall. This results in a block of the nerves leading to the abdominal wall thereby reducing pain sensations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 6 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) classification score 1-3
• age 1 month to 6 years inclusive

Exclusion Criteria:

• children undergoing an additional surgical procedure at an anatomical location not covered by a 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 requiring opioid analgesics
• children with known renal insufficiency
• children with known impaired hepatic function
• children with known impaired cardiac function
• children known hypersensitivity to sodium metabisulfite

Related Conditions & MeSH terms

• Anesthesia

Intervention

Procedure:
• Transversus Abdominis Plane Block
A block needle will be advanced in a medial to lateral direction 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 Anesthesia
Local field infiltration with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg before skin incision.

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, 

References & Publications (1)

Lorenzo AJ, Lynch J, Matava C, El-Beheiry H, Hayes J. Ultrasound guided transversus abdominis plane vs surgeon administered intraoperative regional field infiltration with bupivacaine for early postoperative pain control in children undergoing open pyelop — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Requirement for Morphine Post-surgery.	The primary outcome measure will be the count and percentage of children who require morphine in the recovery room.	Time in recovery room, approximately 60-90 minutes.
Secondary	Total Amount of Morphine (mg/kg) Administered in the Recovery Room.	Patients will receive intravenous morphine 0.05 mg/kg if the FLACC is = 3/10 (equivalent to mild-to-moderate pain). Morphine may be given at 10 minute intervals as per standard protocol until the FLACC score is < 3/10, or the child declines additional pain medicine when offered.	Time in recovery room, approximately 60-90 minutes.
Secondary	Assessment of First Pain Score on Arrival to Recovery Room.	Pain scores will be assessed using the Faces-Legs-Activity-Cry-Consolibility (FLACC) scale for children = 7 years old. The FLACC scale is from 0-10 (0=no pain, 10=worst pain). The scale is composed of five subscales (Faces = facial expression; Legs = lower extremity movement; Activity = degree of movement; Cry = how upset the child is; Consolibity = how easy the child can be consoled). Eacg subscale is rated 0 to 2 (0 = rated as comfortable, no or minimal discomfort for that subscale; 2 = rated as uncomfortable, in pain according to that subscale). The subscales are summed to give a composite score out of 10. Pain scores will be assessed at admission to the recovery room.	On arrival to recovery room.