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NCT03098420 · ClinicalTrials.gov registry record · Phase 2

Dose Escalation of Dexamethasone to Increase Duration of Transversus Abdominal Plane Block Following Cesarean Section

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

Terminated
Registry status
Phase 2
Development phase
29
Enrollment target

NCT03098420: Clinical Trial Phase 2 study, sponsored by University of Alabama at Birmingham.

NCT03098420 is a Phase 2 study that was terminated before completion, run by University of Alabama at Birmingham. The registered enrollment target is 29 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03098420, a Phase 2 study, was terminated before completion, sponsored by University of Alabama at Birmingham.

TERMINATED
Registry status
Phase 2
Development phase
29 participants
Enrollment target

Study Summary

The study aims to improve the care of the obstetric population after cesarean section and improve total patient satisfaction by improving post-surgical pain control with the use of dexamethasone in combination with bilateral TAP blocks. The investigators will utilize a dose-escalation of dexamethasone in the TAP block to observe its effects at specific small doses. It is the hope of the investigator that the studied technique would become utilized routinely for the obstetric population following cesarean section. The investigators hope to show that the addition of dexamethasone in bilateral TAP blocks will prolong the duration of the block in a dose-dependent fashion. The investigators hope to improve post-operative pain following cesarean section, increase duration of TAP block with use of dexamethasone, decrease overall pain scores in the first 24-48 hours, and decrease opioid requirements after cesarean section. The primary endpoint will be estimation of duration of TAP block, being assessed within 48 hours after surgery. Secondary endpoints will include pain scores both in PACU and on the floor, average pain scores, time until first opioid administration, total opioid consumption in first 48 hours, use of PONV medications, and overall patient satisfaction.

Primary Outcome

Average pain score (VAS) 48 hrs postoperatively between the study group and the control. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. 0 represents no pain, whereas 10 represents unbearable pain.

Interventions

  • DRUG Bupivacaine Hydrochloride
  • DRUG Morphine
  • DRUG 2mg Dexamethasone
  • DRUG 4mg Dexamethasone
  • DRUG Ropivacaine (TAP blocks)

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2016-07
Est. Completion 2021-05-20
Phase Phase 2
University of Alabama at Birmingham

1,160 total trials

Why NCT03098420 stopped before completion

NCT03098420 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower).

The record links to 0 conditions, and to 5 interventions - of which Bupivacaine Hydrochloride is the first listed.

NCT03098420 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03098420 about?

NCT03098420 is a clinical study titled "Dose Escalation of Dexamethasone to Increase Duration of Transversus Abdominal Plane Block Following Cesarean Section". The study aims to improve the care of the obstetric population after cesarean section and improve total patient satisfaction by improving post-surgical pain control with the use of dexamethasone in combination with bilateral TAP blocks. The investigators will utilize a dose-escalation of dexamethaso...

What is the current status of trial NCT03098420?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2016-07. Estimated completion is 2021-05-20.

What interventions are being tested in trial NCT03098420?

The interventions under investigation include: Bupivacaine Hydrochloride (DRUG), Morphine (DRUG), 2mg Dexamethasone (DRUG), 4mg Dexamethasone (DRUG), Ropivacaine (TAP blocks) (DRUG).

Who is sponsoring clinical trial NCT03098420?

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 NCT03098420's enrollment target sits among peer trials

29 1669th of 2000 higher than 324 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 NCT03098420, the US trial registry maintained by the National Library of Medicine. NCT03098420 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.