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Tetracaine Combined Spinal Epidural (CSE) Versus Bupivacaine CSE

NCT ID: NCT01005459

Last Updated: 2017-11-08

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-12-12

Brief Summary

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The investigators hypothesis is that spinal tetracaine with fentanyl and epinephrine used for CSE labor analgesia volume will last a significantly longer period of time that that of spinal bupivacaine with fentanyl. After informed consent is obtained for the study, subjects meeting criteria when analgesia is requested will be randomized to receive a combined spinal-epidural containing either tetracaine 2 mg with fentanyl and epinephrine or bupivacaine 2 mg with fentanyl and epinephrine.

Detailed Description

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Conditions

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Labor Pain

Keywords

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labor pain combined spinal epidural labor analgesia CSE analgesia labor analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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tetracaine 2mg

Group Type ACTIVE_COMPARATOR

Tetracaine

Intervention Type DRUG

Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain.

Bupivacaine 2 mg

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.

Interventions

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Tetracaine

Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain.

Intervention Type DRUG

Bupivacaine

Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* early labor (\>=2cm but =\<6cm cervical dilation)
* at least 12 years of age
* have an assigned ASA physical status 1 or 2
* singleton pregnancy

Exclusion Criteria

* contraindications to neuraxial anesthesia
* with allergies to drugs used in the study
* have an assigned ASA status 3 or 4
* advanced labor (\> 6cm cervical dilation)
* less than 12 years of age
* Patients with the potential for distorted epidural anatomy, such as Harrington rods or prior back surgery, will also be excluded.
Minimum Eligible Age

12 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter H. Pan, MD

Role: PRINCIPAL_INVESTIGATOR

WFUHS

Locations

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Forsyth Medical Center- OB Anesthesia dept

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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IRB 9824

Identifier Type: -

Identifier Source: org_study_id