Dento Facial DysmorphismNCT03299998
Evaluation of Maxillary and Mandibulary Nerve Blocks on Morphine Consumption
An observational study of Dento Facial Dysmorphism, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Background and Objectives: Double-jaw surgery is one of the most painful oral surgery, requiring multimodal analgesia including controlled morphine pump and its secondary effects. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dento Facial Dysmorphism
- What is being tested?
- Maxillary and mandibular blocks and General anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 92 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jul 2017to 10 Aug 2017
- Phase
- Observational
- 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 Any age
- Child, Adult, Older adult
Study population: Male and female who underwent double jaw surgery
Who may be able to join
- Male and female who underwent double jaw surgery
Who cannot join
- opposition to the study
- an additional surgical procedure
- preoperative consumption of morphine or derived from morphine
- perioperative N20
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Maxillary and Mandibulary Nerve Blocks on Morphine Consumption in Double-jaw Surgery, a Retrospective Study
Background and Objectives: Double-jaw surgery is one of the most painful oral surgery, requiring multimodal analgesia including controlled morphine pump and its secondary effects. The aim of this study was to evaluate the effectiveness of face block (mandibulary and maxillary block analgesia) on the first 24 hours on morphine consumption in patients admitted for double jaw surgery.
Read the detailed description
Methods: Patients undergoing double-jaw surgery between January 2015 and May 2017 were enrolled. Patients were separated into 2 groups: patients receiving maxillary-mandibulary nerve block and those no receiving it. The primary endpoint was the morphine consumption within 24 hours post-surgery. Secondary endpoints were the intra-operative remifentanil consumption, incidence of postoperative nausea and vomiting at 24 hours, morphine consumption in recovery room, length of stay in hospital.
- Conditions
- Dento Facial Dysmorphism
- Being tested
- Maxillary and mandibular blocks, General anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary and mandibular blocksProcedure or surgery
A Pajunk SonoPlex Stim needle 22G x 55 mm was used. For maxillary nerve block, needle was introduced next to the angle of the orbitae and the zygomatic ridge. The needle was sank until coming into contact of the temporal bone. It was then orientated to the controlateral nostril and sank of 1 cm. For mandibular block, needle was introduced in the pterygoid fossa under and perpendicularly to the zygomatic arch, and sank until the pterygoid process. The needle was then orientated towards controlateral orbitae and sank with neurostimulation. After a motor response at 0.6 milliampere (mA) and the disappearance of contraction at 0.3 mA, local mixture was injected. The mixing of local anesthesia was made of ropivacaine 5 mg/mL and clonidine 30 µg. Five mL were injected in every block for a total of 20 mL.
General anesthesiaProcedure or surgery
Anesthesia was standardized and provided using intravenous administration of propofol and remifentanil. Patients were mechanically ventilated with a mixture of air (50/50), and desflurane or sevoflurane, or Target-controlled infusion (TCI) propofol. One to 5 mg/kg of methyl-prednisolone were administered to reduce inflammatory response.
| Study group | Role | What they receive |
|---|---|---|
| BLOCK+ | Patients who underwent maxillary and mandibulary block before surgery Receives: Procedure: Maxillary and mandibular blocks; Procedure: General anesthesia | |
| BLOCK - | Patients who did not undergo maxillary and mandibulary block before surgery. Receives: Procedure: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative morphine consumption within 24 hours post-surgery
Cumulative morphine consumption measured using patient controlled analgesia (PCA-pump).
Measured: 24 hours
Secondary outcomes (4)
Peroperative remifentanil consumption
Remifentanil consumption in µg.kg-1 during surgery
Measured: End of surgery (2 hours in average)
Cumulative morphine consumption within 12 hours post-surgery
Cumulative morphine consumption measured using patient controlled analgesia (PCA-pump).
Measured: 12 hours
Cumulative morphine consumption within 48 hours post-surgery
Cumulative morphine consumption measured using patient controlled analgesia (PCA-pump).
Measured: 48 hours
Hospital length of stay
Delay between hospitalization date and date of hospital discharge
Measured: Up to hospital discharge (5 days in average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start25 Jul 2017
- Primary completion25 Jul 2017
- Study completion10 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dento Facial DysmorphismStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299998
- Sponsor's protocol ID
- CRC_GHN_2017_001
- Status last verified
- Oct 2017
- First submitted
- 14 Sep 2017
- Last updated
- 3 Oct 2017
- Results posted
- 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 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Maxillary and Mandibulary Nerve Blocks on Morphine Consumption in Double-jaw Surgery, a Retrospective Study
- ClinicalTrials.gov ID
- NCT03299998
- Acronym / sponsor ID
- CRC_GHN_2017_001
- Conditions
- Dento Facial Dysmorphism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 25 Jul 2017 (actual)
- Study completion
- 10 Aug 2017 (actual)
- First posted
- 3 Oct 2017 (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.
Background and Objectives: Double-jaw surgery is one of the most painful oral surgery, requiring multimodal analgesia including controlled morphine pump and its secondary effects. The aim of this study was to evaluate the effectiveness of face block (mandibulary and maxillary block analgesia) on the first 24 hours on morphine consumption in patients admitted for double jaw surgery.
Detailed description
Methods: Patients undergoing double-jaw surgery between January 2015 and May 2017 were enrolled. Patients were separated into 2 groups: patients receiving maxillary-mandibulary nerve block and those no receiving it. The primary endpoint was the morphine consumption within 24 hours post-surgery. Secondary endpoints were the intra-operative remifentanil consumption, incidence of postoperative nausea and vomiting at 24 hours, morphine consumption in recovery room, length of stay in hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BLOCK+ | – | Procedure: Maxillary and mandibular blocks, Procedure: General anesthesiaPatients who underwent maxillary and mandibulary block before surgery |
| BLOCK - | – | Procedure: General anesthesiaPatients who did not undergo maxillary and mandibulary block before surgery. |
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- Male and female who underwent double jaw surgery
Key inclusion criteria (1 listed)
- Male and female who underwent double jaw surgery
Key exclusion criteria (4 listed)
- opposition to the study
- an additional surgical procedure
- preoperative consumption of morphine or derived from morphine
- perioperative N20
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 |
|---|---|---|
| Maxillary and mandibular blocksA Pajunk SonoPlex Stim needle 22G x 55 mm was used. For maxillary nerve block, needle was introduced next to the angle of the orbitae and the zygomatic ridge. The needle was sank until coming into contact of the temporal bone. It was then orientated to the controlateral nostril and sank of 1 cm. For mandibular block, needle was introduced in the pterygoid fossa under and perpendicularly to the zygomatic arch, and sank until the pterygoid process. The needle was then orientated towards controlateral orbitae and sank with neurostimulation. After a motor response at 0.6 milliampere (mA) and the disappearance of contraction at 0.3 mA, local mixture was injected. The mixing of local anesthesia was made of ropivacaine 5 mg/mL and clonidine 30 µg. Five mL were injected in every block for a total of 20 mL. | Procedure or surgery | BLOCK+ |
| General anesthesiaAnesthesia was standardized and provided using intravenous administration of propofol and remifentanil. Patients were mechanically ventilated with a mixture of air (50/50), and desflurane or sevoflurane, or Target-controlled infusion (TCI) propofol. One to 5 mg/kg of methyl-prednisolone were administered to reduce inflammatory response. | Procedure or surgery | BLOCK -, BLOCK+ |
Primary outcome
Cumulative morphine consumption within 24 hours post-surgery
Time frame: 24 hours
Cumulative morphine consumption measured using patient controlled analgesia (PCA-pump).
4 secondary outcomes
Peroperative remifentanil consumption
Time frame: End of surgery (2 hours in average)
Cumulative morphine consumption within 12 hours post-surgery
Time frame: 12 hours
Cumulative morphine consumption within 48 hours post-surgery
Time frame: 48 hours
Hospital length of stay
Time frame: Up to hospital discharge (5 days in average)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
- Individual participant dataSharing planned: No
Related trials for Dento Facial Dysmorphism
Not yet recruitingObservational study
Oral Health, Dento-facial Condition and OHRQoL in Subjects With Mowat-Wilson Syndrome: an Epidemiologic Study.
Mowat-Wilson Syndrome, Dental Caries
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dento Facial Dysmorphism, run by Hospices Civils de Lyon at 1 site in France.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 3 Oct 2017. 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 France. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cumulative morphine consumption within 24 hours post-surgery (time frame: 24 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 3 Oct 2017.