Cleft PalateSuprazygNCT04023825
Analgesic Contribution of the Suprazygomatic Maxillary Nerve Block for Cleft Palate Surgery in Children
A study testing suprazygomatic maxillary nerve block in people with Cleft Palate and Surgery, run by Centre Hospitalier Universitaire, Amiens.
Trial summary
This is a monocentric prospective randomized simple-blind designed study evaluating the superiority of the suprazygomatic maxillary nerve block in analgesia after cleft palate surgery compared with a control group. Every two hours, nurses systematically reassess the patient's pain and adjust the analgesic medications. Read more about this study
- Who is it for?
- Ages 5 months to 12 years
- Conditions the study is for
- Cleft Palate, Surgery
- What is being tested?
- suprazygomatic maxillary nerve block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2019to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children between 5 months and 12 years old
- weight >5kg
- children undergoing cleft palate repair surgery with or without upper lip surgery
Who cannot join
- inappropriate age
- weight <5kg
- abnormal blood coagulation
- local anesthetic contraindication (including levobupivacaine, as well as any other associated treatment administered in this clinical study, including opioids, general anesthetics such as ketamine or propofol, paracetamol or corticosteroids)
- local infection
About this study
This is a monocentric prospective randomized simple-blind designed study evaluating the superiority of the suprazygomatic maxillary nerve block in analgesia after cleft palate surgery compared with a control group. Every two hours, nurses systematically reassess the patient's pain and adjust the analgesic medications. Analgesic requirement, incidence of respiratory complications, re-feeding time and the duration of hospitalization are evaluated.
Read the detailed description
Cleft palate is the most common congenital malformation and requires early surgery given the complications it generates. The surgical site involving the upper airways and the use of morphine are providers of respiratory complications. The suprazygomatic maxillary nerve block could considerably reduce the use of morphine in the postoperative period and thus the respiratory complications in addition to an optimal comfort for the patient. The primary endpoint was to evaluate morphine consumption during the first postoperative 48 hours after cleft palate surgery.
- Conditions
- Cleft Palate, Surgery
- Being tested
- suprazygomatic maxillary nerve block
- Keywords
- cleft palate, surgery, maxillary nerve block, local anesthetic, loco regional anesthesia, face nerve block
- Medical subject headings
- Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suprazygomatic maxillary nerve blockDrug
in the experimental group, each child will profit from the realization of a suprazygomatic maxillary nerve block.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Patients will receive loco regional anesthesia Receives: Drug: suprazygomatic maxillary nerve block |
| control group | No intervention | Patients will not receive loco regional anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of morphine consumption
The main objective of this study is to compare the consumption of morphine during the first 48 hours after cleft palate surgery in a group of patients treated by realization of a suprazygomatic maxillary nerve block, compared to a control group.
Measured: up to 48 hours after cleft palate surgery
Secondary outcomes (4)
Change from baseline of consumption of perioperative morphine
evaluation of the consumption of perioperative morphine
Measured: up to one week after cleft palate surgery
Measure of the number of episodes of respiratory distress
Measure of the number of episodes of respiratory distress
Measured: up to one week after cleft palate surgery
Measure of the period of re-feeding
Measure of the period of re-feeding
Measured: up to one week after cleft palate surgery
Measure of the duration of hospitalization
Measure of the duration of hospitalization
Measured: up to one week after cleft palate surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start1 Jul 2019
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Why it stopped: no participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft PalateStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthieu Miclo, MD, Principal investigator, CHU AmiensEmmanuel Lorne, Pr, Principal investigator, CHU AmiensJérémie Garnier, MD, Principal investigator, CHU AmiensMarie Trujillo-Garcia, MD, Principal investigator, CHU AmiensDimitri Santarelli, MD, Principal investigator, CHU AmiensCica Carole Gbaguidi, MD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023825
- Sponsor's protocol ID
- PI2018_843_0020
- Acronym
- Suprazyg
- Status last verified
- Jun 2026
- First submitted
- 16 Jul 2019
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Contribution of the Suprazygomatic Maxillary Nerve Block for Cleft Palate Surgery in Children
- ClinicalTrials.gov ID
- NCT04023825
- Acronym / sponsor ID
- Suprazyg / PI2018_843_0020
- Conditions
- Cleft Palate, Surgery
- Keywords
- cleft palate, surgery, maxillary nerve block, local anesthetic, loco regional anesthesia, face nerve block
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 18 Jul 2019 (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.
This is a monocentric prospective randomized simple-blind designed study evaluating the superiority of the suprazygomatic maxillary nerve block in analgesia after cleft palate surgery compared with a control group. Every two hours, nurses systematically reassess the patient's pain and adjust the analgesic medications. Analgesic requirement, incidence of respiratory complications, re-feeding time and the duration of hospitalization are evaluated.
Detailed description
Cleft palate is the most common congenital malformation and requires early surgery given the complications it generates. The surgical site involving the upper airways and the use of morphine are providers of respiratory complications. The suprazygomatic maxillary nerve block could considerably reduce the use of morphine in the postoperative period and thus the respiratory complications in addition to an optimal comfort for the patient. The primary endpoint was to evaluate morphine consumption during the first postoperative 48 hours after cleft palate surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: suprazygomatic maxillary nerve blockPatients will receive loco regional anesthesia |
| control group | No intervention | –Patients will not receive loco regional anesthesia |
Who may qualify
- Ages
- 5 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children between 5 months and 12 years old
- weight >5kg
- children undergoing cleft palate repair surgery with or without upper lip surgery
Key exclusion criteria (5 listed)
- inappropriate age
- weight <5kg
- abnormal blood coagulation
- local anesthetic contraindication (including levobupivacaine, as well as any other associated treatment administered in this clinical study, including opioids, general anesthetics such as ketamine or propofol, paracetamol or corticosteroids)
- local infection
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 |
|---|---|---|
| suprazygomatic maxillary nerve blockin the experimental group, each child will profit from the realization of a suprazygomatic maxillary nerve block. | Drug | experimental group |
Primary outcome
Change from baseline of morphine consumption
Time frame: up to 48 hours after cleft palate surgery
The main objective of this study is to compare the consumption of morphine during the first 48 hours after cleft palate surgery in a group of patients treated by realization of a suprazygomatic maxillary nerve block, compared to a control group.
4 secondary outcomes
Change from baseline of consumption of perioperative morphine
Time frame: up to one week after cleft palate surgery
Measure of the number of episodes of respiratory distress
Time frame: up to one week after cleft palate surgery
Measure of the period of re-feeding
Time frame: up to one week after cleft palate surgery
Measure of the duration of hospitalization
Time frame: up to one week after cleft palate surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Cleft Palate
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Furlow With Buccinator and Fistula Formation
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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.
Matthieu Miclo, MD principal investigator
CHU Amiens
Emmanuel Lorne, Pr principal investigator
CHU Amiens
Jérémie Garnier, MD principal investigator
CHU Amiens
Questions about this trial
What is this clinical trial studying?
A study testing suprazygomatic maxillary nerve block in people with Cleft Palate and Surgery, run by Centre Hospitalier Universitaire, Amiens.
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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 from baseline of morphine consumption (time frame: up to 48 hours after cleft palate surgery). 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 11 Jun 2026.