Caudal Versus Rectus Sheath Study
Primary Purpose
Umbilical Hernia
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Umbilical Hernia
Eligibility 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.)
Sites / Locations
- Nationwide Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Caudal epidural
Rectus sheath
Local
Arm Description
The caudal epidural block will be delivered with 1.5ml/kg of 0.25% Bupivacaine up to a maximum of 30 mL.
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.
The surgeon will inject either 0.5% Bupivicaine 0.5ml/kg or 0.25% Bupivicaine 1ml/kg at the surgeon's discretion.
Outcomes
Primary Outcome Measures
Post-operative Pain Score
Hannallah et al developed the Objective Pain Scale (OPS) to monitor pain in children after surgery. Parameters: (1) systolic blood pressure, (2) crying, (3) movement, (4) agitation (confused, excited), (5) complains of pain (may not be possible in younger children). Interpretation: minimum score: 0; maximum score: 10; maximum score if too young to complain of pain: 8; the higher the score, the greater the degree of pain.
Secondary Outcome Measures
Full Information
NCT ID
NCT01394523
First Posted
July 11, 2011
Last Updated
November 21, 2017
Sponsor
Nationwide Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01394523
Brief Title
Caudal Versus Rectus Sheath Study
Official Title
A Prospective, Double-blinded, Randomized Comparison of Caudal Analgesia Versus Ultrasound Guided Rectus Sheath Blocks for Umbilical Herniorrhaphy in the Pediatric Population
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
Interim power analysis was prohibitive to continuing the study
Study Start Date
August 2011 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Umbilical Hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Caudal epidural
Arm Type
Active Comparator
Arm Description
The caudal epidural block will be delivered with 1.5ml/kg of 0.25% Bupivacaine up to a maximum of 30 mL.
Arm Title
Rectus sheath
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Local
Arm Type
Active Comparator
Arm Description
The surgeon will inject either 0.5% Bupivicaine 0.5ml/kg or 0.25% Bupivicaine 1ml/kg at the surgeon's discretion.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
0.25% or 0.5%
Primary Outcome Measure Information:
Title
Post-operative Pain Score
Description
Hannallah et al developed the Objective Pain Scale (OPS) to monitor pain in children after surgery. Parameters: (1) systolic blood pressure, (2) crying, (3) movement, (4) agitation (confused, excited), (5) complains of pain (may not be possible in younger children). Interpretation: minimum score: 0; maximum score: 10; maximum score if too young to complain of pain: 8; the higher the score, the greater the degree of pain.
Time Frame
30 minutes
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.)
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Caudal Versus Rectus Sheath Study
We'll reach out to this number within 24 hrs