- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01394523
Caudal Versus Rectus Sheath Study
November 21, 2017 updated by: Tarun Bhalla, MD, Nationwide Children's Hospital
A Prospective, Double-blinded, Randomized Comparison of Caudal Analgesia Versus Ultrasound Guided Rectus Sheath Blocks for Umbilical Herniorrhaphy in the Pediatric Population
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
Study Overview
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
|
0.25% or 0.5%
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-operative Pain Score
Time Frame: 30 minutes
|
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.
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
July 11, 2011
First Submitted That Met QC Criteria
July 13, 2011
First Posted (Estimate)
July 14, 2011
Study Record Updates
Last Update Posted (Actual)
December 19, 2017
Last Update Submitted That Met QC Criteria
November 21, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB11-00363
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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