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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Bupivacaine 		1 ml 0.5% isobaric bupivacaine (5 mg) + 15 mcg fentanyl intrathecal plus epidural volume extension (EVE)
  • Drug: Bupivacaine
    1 cc of 0.5% bupivacaine with 15 mcg fentanyl 10 cc of sterile saline in the epidural
Experimental
Chloroprocaine 		5 ml 1% spinal chloroprocaine (50 mg) intrathecal plus epidural volume extension (EVE)
  • Drug: Chloroprocaine
    Adding 5 cc 1% Chloroprocaine with 10 cc sterile saline in the epidural

More Details

Status
Terminated
Sponsor
University of Alabama at Birmingham

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.