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Caudal Versus Rectus Sheath Study

NCT ID: NCT01394523

Last Updated: 2017-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2016-09-30

Brief Summary

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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

Detailed Description

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Conditions

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Umbilical Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Caudal epidural

The caudal epidural block will be delivered with 1.5ml/kg of 0.25% Bupivacaine up to a maximum of 30 mL.

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

0.25% or 0.5%

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.

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

0.25% or 0.5%

Local

The surgeon will inject either 0.5% Bupivicaine 0.5ml/kg or 0.25% Bupivicaine 1ml/kg at the surgeon's discretion.

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

0.25% or 0.5%

Interventions

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Bupivacaine

0.25% or 0.5%

Intervention Type DRUG

Eligibility Criteria

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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.)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nationwide Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tarun Bhalla, MD

Attending Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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IRB11-00363

Identifier Type: -

Identifier Source: org_study_id