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NCT03993314 · ClinicalTrials.gov registry record · Phase 2

Optimizing Anesthesia for Post Partum Tubal Ligations

A Phase 2 study, sponsored by University of Alabama at Birmingham.

Terminated
Registry status
Phase 2
Development phase
15
Enrollment target

NCT03993314: Clinical Trial Phase 2 study, sponsored by University of Alabama at Birmingham.

NCT03993314 is a Phase 2 study that was terminated before completion, run by University of Alabama at Birmingham. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03993314, a Phase 2 study, was terminated before completion, sponsored by University of Alabama at Birmingham.

TERMINATED
Registry status
Phase 2
Development phase
15 participants
Enrollment target

Study Summary

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.

Primary Outcome

Degree of analgesia is determined by the level of the block. Block level may be T1 (highest level of numbness), T2, T3, T4, T5, T6, T7,T8, T9 , T10, T11, T12, L1, L2, L3, or L4 (lowest level or numbness). A level of numbness of T6 or higher is required for an adequate surgical block. Participants are classified as having either an adequate level of numbness (T1, T2, T3, T4, T5, or T6) or an inadequate level (T7,T8, T9 , T10, T11, T12, L1, L2, L3, or L4).

Interventions

  • DRUG Bupivacaine
  • DRUG Chloroprocaine

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2019-08-13
Est. Completion 2020-12-03
Phase Phase 2
University of Alabama at Birmingham

1,160 total trials

Why NCT03993314 stopped before completion

NCT03993314 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).

The record links to 0 conditions, and to 2 interventions - of which Bupivacaine is the first listed.

NCT03993314 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03993314 about?

NCT03993314 is a clinical study titled "Optimizing Anesthesia for Post Partum Tubal Ligations". 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...

What is the current status of trial NCT03993314?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2019-08-13. Estimated completion is 2020-12-03.

What interventions are being tested in trial NCT03993314?

The interventions under investigation include: Bupivacaine (DRUG), Chloroprocaine (DRUG).

Who is sponsoring clinical trial NCT03993314?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03993314's enrollment target sits among peer trials

15 1919th of 2000 higher than 60 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03993314, the US trial registry maintained by the National Library of Medicine. NCT03993314 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.