Mouth AbnormalitiesPhase 4NCT03632044
Evaluation of Trigeminal Nerve Blockade
A Phase 4 study testing Ropivacaine in people with Mouth Abnormalities and Cleft Palate, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 5 years
- Conditions the study is for
- Mouth Abnormalities, Cleft Palate, Birth Defect
- What is being tested?
- Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2018to 30 Oct 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Trigeminal Nerve Blockade in the Pterygopalatine Fossa for Cleft Palate Repair: a Pilot Study
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.
Read the detailed description
Cleft palate is a common congenital anomaly for which surgical repair is indicated during early childhood. The surgical repair of cleft palate is very painful, and generally requires high doses of opioids for adequate pain control, placing children at risk for post-operative respiratory depression and airway obstruction. An alternative approach to post-operative analgesia for cleft palate repair is the placement of nerve blocks in the pterygopalatine fossa bilaterally, blocking the maxillary nerve and covering the entire mid-face. This randomized, double-blinded study will investigate the utility of maxillary nerve blockade in controlling post-operative pain, decreasing opioid requirements, improving post-operative oral food and drink intake, and decreasing hospital length-of-stay after cleft palate repair.
- Conditions
- Mouth Abnormalities, Cleft Palate, Birth Defect
- Being tested
- Ropivacaine, Sham Comparator
- Medical subject headings
- Mouth Abnormalities, Cleft Palate, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called Naropin
A single injection into the pterygopalatine fossa bilaterally of 0.2% ropivacaine at a dose of 0.15 mL/kg (block) after the induction of general anesthesia
Sham ComparatorOther
Also called Control
The subcutaneous placement of a 25 Gauge needle as a sham control after the induction of general anesthesia. Nothing will be injected.
| Study group | Role | What they receive |
|---|---|---|
| Suprazygomatic maxillary nerve blockade | Experimental | A single injection into the pterygopalatine fossa bilaterally of 0.2% ropivacaine at a dose of 0.15 mL/kg (block) after the induction of general anesthesia. Receives: Drug: Ropivacaine |
| 25 Gauge needle | Sham comparator | Subcutaneous placement of a 25 Gauge needle as a sham comparator after the induction of general anesthesia. Nothing will be injected. Receives: Other: Sham Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in time to oral intake following palatoplasty for cleft palate
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.
Measured: Change from baseline (post-op) and through study completion, an average of 96 hours.
Secondary outcomes (2)
Change in amount of opioids following palatoplasty for cleft palate
Application of bilateral suprazygomatic maxillary nerve blockade of the infraorbital nerve to provide effective analgesia for cleft lip repair, improving pain control after surgery.
Measured: Change from baseline (post-op) and through study completion, an average of 96 hours.
Change in length of hospitalization following palatoplasty for cleft palate
Application of bilateral suprazygomatic maxillary nerve blockade of the infraorbital nerve to provide effective analgesia for cleft lip repair, improving time to hospital discharge after surgery.
Measured: Change from baseline (post-op) and through study completion, an average of 96 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start20 Nov 2018
- Primary completion31 May 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mouth AbnormalitiesStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This randomized, double-blinded study. Subjects will be randomly assigned to one of two different protocols by a designated study team member based on a computer generated randomization table. Randomization will occur following consent. Randomization will be 1:1.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cameron R Smith, MD, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632044
- Sponsor's protocol ID
- IRB201801011
- Other IDs
- OCR18511
- Status last verified
- Nov 2025
- First submitted
- 6 Aug 2018
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Trigeminal Nerve Blockade in the Pterygopalatine Fossa for Cleft Palate Repair: a Pilot Study
- ClinicalTrials.gov ID
- NCT03632044
- Acronym / sponsor ID
- IRB201801011
- Conditions
- Mouth Abnormalities, Cleft Palate, Birth Defect
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cleft palate is a common congenital anomaly for which surgical repair is indicated during early childhood. The surgical repair of cleft palate is very painful, and generally requires high doses of opioids for adequate pain control, placing children at risk for post-operative respiratory depression and airway obstruction. An alternative approach to post-operative analgesia for cleft palate repair is the placement of nerve blocks in the pterygopalatine fossa bilaterally, blocking the maxillary nerve and covering the entire mid-face. This randomized, double-blinded study will investigate the utility of maxillary nerve blockade in controlling post-operative pain, decreasing opioid requirements, improving post-operative oral food and drink intake, and decreasing hospital length-of-stay after cleft palate repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This randomized, double-blinded study. Subjects will be randomly assigned to one of two different protocols by a designated study team member based on a computer generated randomization table. Randomization will occur following consent. Randomization will be 1:1.
| Arm | Type | Receives |
|---|---|---|
| Suprazygomatic maxillary nerve blockade | Experimental | Drug: RopivacaineA single injection into the pterygopalatine fossa bilaterally of 0.2% ropivacaine at a dose of 0.15 mL/kg (block) after the induction of general anesthesia. |
| 25 Gauge needle | Sham comparator | Other: Sham ComparatorSubcutaneous placement of a 25 Gauge needle as a sham comparator after the induction of general anesthesia. Nothing will be injected. |
Who may qualify
- Ages
- 3 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RopivacaineAlso: NaropinA single injection into the pterygopalatine fossa bilaterally of 0.2% ropivacaine at a dose of 0.15 mL/kg (block) after the induction of general anesthesia | Drug | Suprazygomatic maxillary nerve blockade |
| Sham ComparatorAlso: ControlThe subcutaneous placement of a 25 Gauge needle as a sham control after the induction of general anesthesia. Nothing will be injected. | Other | 25 Gauge needle |
Primary outcome
Change in time to oral intake following palatoplasty for cleft palate
Time frame: Change from baseline (post-op) and through study completion, an average of 96 hours.
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.
2 secondary outcomes
Change in amount of opioids following palatoplasty for cleft palate
Time frame: Change from baseline (post-op) and through study completion, an average of 96 hours.
Change in length of hospitalization following palatoplasty for cleft palate
Time frame: Change from baseline (post-op) and through study completion, an average of 96 hours.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cameron R Smith, MD, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine in people with Mouth Abnormalities and Cleft Palate, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in time to oral intake following palatoplasty for cleft palate (time frame: Change from baseline (post-op) and through study completion, an average of 96 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.