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TAPB vs. Caudal for Lower Abdominal Surgery in Children: A Double-Blinded Randomized Controlled Trial

Transversus Abdominis Plane Block Versus Caudal Epidural for Lower Abdominal Surgery in Children: A Double-Blinded Randomized Controlled Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02160821
Enrollment
45
Registered
2014-06-11
Start date
2011-01-31
Completion date
2014-05-31
Last updated
2014-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Recovery Period

Keywords

Transversus Abdominis Plane Block, Caudal Epidural, Pediatric Pain control, Pain control for Lower Abdominal Surgery

Brief summary

Transversus abdominis plane block (TAPB) has emerged as a safe and effective regional anesthesia technique for providing postoperative lower abdominal analgesia. Complications associated with TAPB are very rare and pose a lower overall risk to the patient receiving a TAPB versus a caudal block, which is considered the gold standard for pediatric lower abdominal regional anesthesia. Our study hypothesis was that TAPB would be equivalent to caudal block initially in providing postoperative pain control but would show improved pain relief beyond the anticipated caudal duration.

Detailed description

The study design was a double-blinded randomized controlled trial. A minimum of 44 children between the ages of 1 and 9 undergoing bilateral ureteral reimplantation surgery through a low transverse incision will be enrolled. Narcotic requirement, pain scores (FLACC/FACES), episodes of nausea/vomiting, and anti-spasmodic requirement will be recorded in the PACU and at 6 hour intervals through 24 hours from the time of the block placement.

Interventions

Ultrasound Guided Caudal Block

PROCEDURETransversus Abdominis Plane Block

Ultrasound Guided Transversus Abdominis Plane Block

Sponsors

Nemours Children's Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Years to 9 Years
Healthy volunteers
No

Inclusion criteria

* Patients aged 1 to 9 years old scheduled for intravesicular ureteral reimplantation surgery

Exclusion criteria

1. Coagulation status or anatomic variations precluded safe placement of either TAPB or caudal epidural, 2. there was a preexisting chronic pain disorder, 3. there was a history of constipation that persisted despite appropriate treatment and that may have impacted postoperative pain assessments, 4. additional procedures were planned via a separate incision at the time of the ureteral reimplantation, 5) there was a contraindication to receiving the medications described in the protocol.

Design outcomes

Primary

MeasureTime frameDescription
Narcotic requirement24 hours post interventionNarcotic requirement was recorded at 24 hours from the time of the block placement.

Secondary

MeasureTime frameDescription
episodes of nausea/vomiting24 hoursEpisodes of nausea/vomiting were recorded at 24 hours from the time of the block placement.
anti-spasmodic requirement24 hours post interventionAnti-spasmodic requirement were recorded at 24 hours from the time of the block placement.
Pain Scores24 hours post interventionPain scores (FLACC/FACES) were recorded at 24 hours from the time of the block placement

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026