Optimizing Anesthesia for Post Partum Tubal Ligations

The University of Alabama at Birmingham

Status and phase: Terminated; Phase 2

Conditions: Pregnancy Related

Treatments: Drug: Bupivacaine; Drug: Chloroprocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03993314

IRB-300003361

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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15 participants in 2 patient groups

Bupivacaine

Active Comparator group

Description:

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

Treatment:

Drug: Bupivacaine

Chloroprocaine

Experimental group

Description:

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

Treatment:

Drug: Chloroprocaine