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Completed

NCT Number: NCT01243593

Transversus Abdominis Plane Block in Children Undergoing Open Pyeloplasty Surgery

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.

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Key information

Conditions

Age range

1 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transversus abdominis plane block

Procedure

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

Procedure

Local field infiltration with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg before skin incision.

Primary outcomes

  1. Requirement for Morphine Post-surgery.

    Time frame: Time in recovery room, approximately 60-90 minutes.

    The primary outcome measure will be the count and percentage of children who require morphine in the recovery room.

Secondary outcomes

  1. Total Amount of Morphine (mg/kg) Administered in the Recovery Room.

    Time frame: Time in recovery room, approximately 60-90 minutes.

    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.

  2. Assessment of First Pain Score on Arrival to Recovery Room.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Nov 18, 2010
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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