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Clinical Trials/NCT06403462
NCT06403462CompletedNot Applicable

Comparison Between Ultrasound-guided Transversus Abdominis Plane and Transversalis Fascia Plane Block for Pediatric Patients Undergoing Alveoloplasty With Iliac Bone Graft: a Prospective Randomized Controlled Trial

Seoul National University Hospital1 site in 1 country40 target enrollmentStarted: May 7, 2024Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
total consumption of opioid (mcg/kg)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to determine which method is more effective in postoperative pain control in children undergoing iliac bone grafting for alveoloplasty under general anesthesia: ultrasound-guided transverse abdominal blockade or transversalis fascia plane block

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
7 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Children aged 7 years and older but under 18 undergoing iliac bone grafting for alveoloplasty

Exclusion Criteria

  • •Patients with diseases that affect pain sensitivity differently from the general population (e.g., congenital insensitivity to pain with anhidrosis, complex regional pain syndrome, etc.)
  • •Cases where there is difficulty in expressing pain (due to cognitive or functional deficits, or limited ability to communicate)
  • •Unstable vital signs (heart rate, blood pressure)
  • •Common contraindications for Ropivacaine: 1) Patients with a history of hypersensitivity to this drug or other amide local anesthetics, 2) Patients in a state of major bleeding or shock, 3) Patients with inflammation at or around the site of administration, 4) Patients with sepsis, 5) Intravenous regional anesthesia (Bier block)
  • •History of allergy to opioid medications
  • •Severe renal impairment (Creatinine >3.0mg/dL)
  • •Severe liver function abnormalities (aspartate transaminase > 120 unit/L, alanine aminotransferase > 120 unit/L)
  • •Peripheral nervous system disorders
  • •Other cases deemed unsuitable by the researcher

Arms & Interventions

transversus abdominis plane block

Active Comparator

Intervention: transversus abdominis plane block (Procedure)

transversalis fascial plane block

Experimental

Intervention: transversalis fascial plane block (Procedure)

Outcomes

Primary Outcomes

total consumption of opioid (mcg/kg)

Time Frame: from the end of surgery up to 24 hours later

total opioid consumption at 24 hours after the end of surgery

Secondary Outcomes

  • The incidence of side effects of analgesic medications (percent)(within 24 hours after the end of surgery)
  • Postoperative Pain score(at 30 minutes, 1 hour, 3 hours, 6 hours, 24 hours after the end of surgery)
  • Total consumption of non-opioid (mg/kg)(within 24 hours after the end of surgery)
  • Procedure time (min)(within 10 minutes after the end of surgery)
  • Cold sensation(at 30 minutes after the end of surgery)
  • First ambulation (hours)(within 24 hours after the end of surgery)
  • Sleep quality score(at 24 hours after the end of surgery)
  • Satisfaction score(at 24 hours after the end of surgery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jin-Tae Kim

Professor

Seoul National University Hospital

Study Sites (1)

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