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

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ClinicalTrials.gov Identifier: NCT02160821
Recruitment Status : Completed
First Posted : June 11, 2014
Last Update Posted : June 11, 2014
Sponsor:
Information provided by (Responsible Party):
Nemours Children's Clinic

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.

Condition or disease Intervention/treatment Phase
Anesthesia, Recovery Period Procedure: Caudal Epidural Procedure: Transversus Abdominis Plane Block Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Transversus Abdominis Plane Block Versus Caudal Epidural for Lower Abdominal Surgery in Children: A Double-Blinded Randomized Controlled Trial
Study Start Date : January 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : May 2014

Arm Intervention/treatment
Experimental: Transversus Abdominis Plane Block
Transversus Abdominis Plane Block TAPB Ultrasound guided TAPB
Procedure: Transversus Abdominis Plane Block
Ultrasound Guided Transversus Abdominis Plane Block

Experimental: Caudal Epidural Block
Caudal Epidural Block Caudal Block Neuraxial Block Ultrasound Guided Caudal Block
Procedure: Caudal Epidural
Ultrasound Guided Caudal Block




Primary Outcome Measures :
  1. Narcotic requirement [ Time Frame: 24 hours post intervention ]
    Narcotic requirement was recorded at 24 hours from the time of the block placement.


Secondary Outcome Measures :
  1. episodes of nausea/vomiting [ Time Frame: 24 hours ]
    Episodes of nausea/vomiting were recorded at 24 hours from the time of the block placement.

  2. anti-spasmodic requirement [ Time Frame: 24 hours post intervention ]
    Anti-spasmodic requirement were recorded at 24 hours from the time of the block placement.

  3. Pain Scores [ Time Frame: 24 hours post intervention ]
    Pain scores (FLACC/FACES) were recorded at 24 hours from the time of the block placement



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Ages Eligible for Study:   1 Year to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160821


Locations
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United States, Florida
Wolfson Children's Hospital, Baptist Medical Center- Downtown, 800 Prudential Drive
Jacksonville, Florida, United States, 32207
Sponsors and Collaborators
Nemours Children's Clinic
Investigators
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Principal Investigator: Robert B Bryskin, MD Nemours Children's Clinic
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT02160821    
Other Study ID Numbers: 1610841001
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: June 11, 2014
Last Verified: June 2014
Keywords provided by Nemours Children's Clinic:
Transversus Abdominis Plane Block
Caudal Epidural
Pediatric Pain control
Pain control for Lower Abdominal Surgery