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Caudal Versus Rectus Sheath Study

This study has been terminated.
(Interim power analysis was prohibitive to continuing the study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01394523
First Posted: July 14, 2011
Last Update Posted: November 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tarun Bhalla, MD, Nationwide Children's Hospital
  Purpose
The literature has clearly demonstrated that the effective treatment of postoperative pain in infants and children is challenging. In an effort to improve postoperative analgesia while limiting opioid-related adverse effects, there continues to be an increased use of regional anesthetic techniques in infants and children. Although the pediatric caudal remains the most commonly used pediatric regional anesthetic technique, it has been demonstrated that effective analgesia can be provided with the use of peripheral nerve blockade even in the pediatric-aged patient. The purpose of this study is to prospectively compare post-operative pain relief in pediatric patients undergoing umbilical hernia repair who have received either a caudal block or bilateral rectus sheath blocks for analgesia

Condition Intervention Phase
Umbilical Hernia Drug: Bupivacaine Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Double-blinded, Randomized Comparison of Caudal Analgesia Versus Ultrasound Guided Rectus Sheath Blocks for Umbilical Herniorrhaphy in the Pediatric Population

Resource links provided by NLM:


Further study details as provided by Tarun Bhalla, MD, Nationwide Children's Hospital:

Primary Outcome Measures:
  • Post-operative pain score [ Time Frame: 60 minutes ]

Enrollment: 39
Study Start Date: August 2011
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Caudal epidural
The caudal epidural block will be delivered with 1.5ml/kg of 0.25% Bupivacaine up to a maximum of 30 mL.
Drug: Bupivacaine
0.25% or 0.5%
Active Comparator: Rectus sheath
The rectus sheath block will be performed with 0.1ml/kg of 0.25% Bupivacaine on each side at the T9-T10 distribution under ultrasound guidance.
Drug: Bupivacaine
0.25% or 0.5%
Active Comparator: Local
The surgeon will inject either 0.5% Bupivicaine 0.5ml/kg or 0.25% Bupivicaine 1ml/kg at the surgeon's discretion.
Drug: Bupivacaine
0.25% or 0.5%

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA physical status I or II
  • Weight less than or equal to 20 kg
  • Presenting for repair of umbilical hernia

Exclusion Criteria:

  • ASA physical status > II
  • Weight greater than 20 kg
  • Co-morbid diseases (cardiac, pulmonary, neurological disease)
  • Patients having concomitant procedures (circumcision, orchiopexy, etc.)
  Contacts and Locations
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): NCT01394523


Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
  More Information

Responsible Party: Tarun Bhalla, MD, Attending Anesthesiologist, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01394523     History of Changes
Other Study ID Numbers: IRB11-00363
First Submitted: July 11, 2011
First Posted: July 14, 2011
Last Update Posted: November 22, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Hernia, Umbilical
Infant, Newborn, Diseases
Hernia, Ventral
Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents