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Optimizing Anesthesia for Post Partum Tubal Ligations

NCT ID: NCT03993314

Last Updated: 2021-12-17

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-13

Study Completion Date

2020-12-03

Brief Summary

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In this study, the investigators will compare CLOROTEKAL® (1% spinal chloroprocaine) to low-dose isobaric bupivacaine using the epidural volume extension (EVE) technique in patients undergoing post-partum tubal ligation (PPBTL). This will be a randomized, double-blinded study. Patients scheduled for PPBTL at the Women and Infants Center (WIC) will be eligible for enrollment in this study. Outcomes measured will include: ability to achieve an adequate level required for surgery (T6), rate of epidural activation, and duration of the block. The investigators hope to determine the usefulness of each drug using the EVE technique in the setting of PPBTL.

Detailed Description

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Conditions

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Pregnancy Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Bupivacaine

1 ml 0.5% isobaric bupivacaine (5 mg) + 15 mcg fentanyl intrathecal plus epidural volume extension (EVE)

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

1 cc of 0.5% bupivacaine with 15 mcg fentanyl 10 cc of sterile saline in the epidural

Chloroprocaine

5 ml 1% spinal chloroprocaine (50 mg) intrathecal plus epidural volume extension (EVE)

Group Type EXPERIMENTAL

Chloroprocaine

Intervention Type DRUG

Adding 5 cc 1% Chloroprocaine with 10 cc sterile saline in the epidural

Interventions

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Chloroprocaine

Adding 5 cc 1% Chloroprocaine with 10 cc sterile saline in the epidural

Intervention Type DRUG

Bupivacaine

1 cc of 0.5% bupivacaine with 15 mcg fentanyl 10 cc of sterile saline in the epidural

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Any patient scheduled for a postpartum tubal ligation at the Women and Infants Center will be eligible for the study

Exclusion Criteria

* age less than 18 years old
* allergy to either local anesthetic class (amide or ester)
* contraindication to spinal anesthesia
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Mark Powell

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark F Powell, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB-300003361

Identifier Type: -

Identifier Source: org_study_id