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Nerve block may cut opioid use after cleft palate repair

NCT ID NCT03632044

Symptom relief Sponsor: University of Florida Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 22, 2026 · Updated 2 times

Summary

This study tests whether a nerve block placed in the face can reduce pain and the need for strong opioid drugs after cleft palate surgery in children. The goal is to help kids start eating and drinking sooner and go home faster. The study involves 40 children having cleft palate repair.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2018

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 months to 5 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient presenting for palatoplasty for cleft palate only. * Parent/guardian consents to participate * Normal oral food and water intake before surgery * No underlying chronic pain condition Exclusion Criteria: * Parent/guardian refuses to consent * Patient requires revision surgery on the palate * Patient requires surgery in addition to palatoplasty, including, but not limited to pharyngeal flap or soft palate lengthening procedures. * Any underlying chronic pain condition * Presence of any other factor which, at the discretion of any member of the study team, makes the patient a poor candidate for block placement. * Presence of any other factor which, at the discretion of any member of the study team, makes 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

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Conditions

The condition(s) this trial relates to.

cleft palate Congenital Abnormalities Mouth Abnormalities mouth disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Birth defect Cleft palate Mouth abnormalities

Contacts and locations

Locations

  • UF Health

    Gainesville, Florida, 32610-3003, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.