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Evaluation of Trigeminal Nerve Blockade

StatusActive, Not Recruiting
PhasePhase 4
Started2018-11-20
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later May 31, 2026 → May 31, 2027
See other at-risk trials from University of Florida

Amendment history

2026-07-20
Study Status v17
Primary completion pushed: 2026-05-31 → 2027-05-31
2026-01-15
Enrolling by Invitation→Active, Not Recruiting Study Status v16
Trial statusEnrolling by Invitation→Active, Not Recruiting
Primary completion date2025-10-07→2026-05-31
Completion date2025-10-07→2027-10-30
2024-10-08
Study Status v15
Primary completion date2024-06-30→2025-10-07
Completion date2024-06-30→2025-10-07
2024-05-29
Study Status, Study Design v14
PhaseEarly Phase 1→Phase 4
2023-09-07
Study Status v13
Primary completion date2023-06-30→2024-06-30
Show 12 earlier versions
2023-05-26
Study Status v12
Primary completion date2022-12→2023-06-30
Completion date2023-03→2024-06-30
2022-05-23
Study Status v11
Primary completion date2022-03→2022-12
Completion date2022-03→2023-03
2021-03-23
Study Status v10
Primary completion date2021-05→2022-03
Completion date2021-05→2022-03
2020-05-14
Study Status v9
Primary completion date2020-09→2021-05
Completion date2020-12→2021-05
2019-07-23
3 amendments v6-v8
3 re-verifications since 2018-12-28, no change to tracked fields
2018-11-20
Study Status v5
Start dateestimated 2018-12-15→confirmed 2018-11-20
2018-10-26
Study Status v4
Start date2018-10-15→2018-12-15
2018-10-24
Study Status, Eligibility v3
Eligibility criteria+53 characters
[...] d to pharyngeal flap or soft palate lengthening procedures. Age younger than 3 months or greater than 5 years Any underlying chronic pain condition Presence of any other [...] kes the patient a poor candidate for research participation. History of Pierre Robin sequence Planned or anticipated need for any type of artificial airway post-op
2018-09-12
Not Yet Recruiting→Enrolling by Invitation Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Enrolling by Invitation
Start date2018-08→2018-10-15
2018-08-22
Study Status v1
Re-verified, no change to tracked fields
2018-08-13
Original filing
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.
Trial Details
NCT Number NCT03632044
Lead Sponsor University of Florida
Conditions Mouth Abnormalities, Cleft Palate, Birth Defect
Enrollment 40 participants
Start Date 2018-11-20
Primary Completion 2027-05-31 (estimated)
Study Completion 2027-10-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-21