Caudal Versus Rectus Sheath Study

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Tarun Bhalla, MD, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01394523
First received: July 11, 2011
Last updated: March 31, 2014
Last verified: March 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Nationwide Children's Hospital:

Primary Outcome Measures:
  • Post-operative pain score [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: August 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394523

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

No publications provided

Responsible Party: Tarun Bhalla, MD, Attending Anesthesiologist, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01394523     History of Changes
Other Study ID Numbers: IRB11-00363
Study First Received: July 11, 2011
Last Updated: March 31, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 30, 2014