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NCT03632044 · ClinicalTrials.gov registry record · Phase 4

Evaluation of Trigeminal Nerve Blockade

A Phase 4 study of Cleft Palate and Birth Defect, sponsored by University of Florida.

Active
Registry status
Phase 4
Development phase
40
Enrollment target
1
Study location

NCT03632044: Active Phase 4 study of Cleft Palate and Birth Defect, sponsored by University of Florida.

NCT03632044 is a Phase 4 study of Cleft Palate and Birth Defect that is active but no longer recruiting, run by University of Florida. The registered enrollment target is 40 participants, below the 670-participant average among 9 other Cleft Palate trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03632044, a Phase 4 study of Cleft Palate and Birth Defect, is active but no longer recruiting, sponsored by University of Florida.

ACTIVE NOT RECRUITING
Registry status
Phase 4
Development phase
40 participants
Enrollment target
1
Study location

Study Summary

Cleft palate repair requires high doses of opioids for pain control postop. An alternative approach is placement of nerve blocks in the pterygopalatine fossa bilaterally, blocking the maxillary nerve \& covering the entire midface. Application of bilateral suprazygomatic maxillary nerve blockade of the infraorbital nerve may provide effective analgesia for cleft lip repair, improving time to oral intake, pain control and time to hospital discharge.

Primary Outcome

Application of bilateral suprazygomatic maxillary nerve blockade of the infraorbital nerve to provide effective analgesia for cleft lip repair, improving time to oral intake after surgery.

Interventions

  • DRUG Ropivacaine
  • OTHER Sham Comparator

Study Locations (1)

Florida

  • UF Health - Gainesville

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2018-11-20
Est. Completion 2027-10-30
Phase Phase 4
University of Florida

1,106 total trials

What the registry record for NCT03632044 still lists

NCT03632044 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 670-participant average among 9 other Cleft Palate trials with a reported enrollment target (94% lower).

The record links to 3 conditions, with Cleft Palate appearing as the primary indexed condition, and to 2 interventions - of which Ropivacaine is the first listed.

NCT03632044 reports a single indexed study location in Florida.

Frequently Asked Questions

What is clinical trial NCT03632044 about?

NCT03632044 is a clinical study titled "Evaluation of Trigeminal Nerve Blockade". Cleft palate repair requires high doses of opioids for pain control postop. An alternative approach is placement of nerve blocks in the pterygopalatine fossa bilaterally, blocking the maxillary nerve \& covering the entire midface. Application of bilateral suprazygomatic maxillary nerve blockade of ...

What is the current status of trial NCT03632044?

This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2018-11-20. Estimated completion is 2027-10-30.

What conditions does trial NCT03632044 study?

This clinical trial studies the following conditions: Cleft Palate, Birth Defect, Mouth Abnormalities.

What interventions are being tested in trial NCT03632044?

The interventions under investigation include: Ropivacaine (DRUG), Sham Comparator (OTHER).

Who is sponsoring clinical trial NCT03632044?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03632044 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Cleft Palate

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03632044's enrollment target sits among peer trials

40 9th of 9 higher than 1 of 9 other Cleft Palate trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Cleft Palate 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 NCT03632044, the US trial registry maintained by the National Library of Medicine. NCT03632044 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.