Optimizing Anesthesia for Post Partum Tubal Ligations

The University of Alabama at Birmingham logo

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

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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