Pain, Post OperativeECHOMAXNCT05351151
Pain Reduction in Maxillomandibular Surgery Using Maxillary and Mandibular Nerve Blocks
A study testing bilateral ultra-sound guided maxillary and mandibular nerve blocks and Infiltration of Lidocaine 1% in people with Pain, Post Operative and Regional Anesthesia, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Maxillo-mandibular osteotomy is a painful surgery which requires mostly opioids use. Recent studies on maxillary and mandibular nerve blocks have suggested benefit in maxillo-facial surgery but have been poorly investigated in orthognathic surgery. Read more about this study
- Who is it for?
- Ages 15 to 45 years
- Conditions the study is for
- Pain, Post Operative, Regional Anesthesia
- What is being tested?
- bilateral ultra-sound guided maxillary and mandibular nerve blocks and Infiltration of Lidocaine 1%
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2022to 29 Mar 2023
- 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 15 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients from 15 to 45 years old,
- Scheduled for maxillary-mandibular osteotomy,
- Registered in French social insurance register,
- With informed consent disclosure.
Who cannot join
- American Society of Anesthesiologists (ASA) classification ≥ 3
- Innate or acquired hemostasis pathology,
- Peripheric neuropathy,
- Drug intake for chronic pain,
- Infection/scar at needle insertion site,
- Associated rhinoplasty surgery,
Show all 13Show fewer
- Allergy to local anesthetics,
- Pregnant woman or potentially,
- Breastfeeding woman,
- Already registered in other clinical trial,
- Adults under legal protection of incapable adult,
- Cognitive disease impairing using of evaluation tools performed in protocol,
- All contraindication of anesthetics drugs used in protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Efficacy of Echoguided Maxillary and Mandibular Nerve Blocks in Planned Maxillomandibular Osteotomy Surgery
Maxillo-mandibular osteotomy is a painful surgery which requires mostly opioids use. Recent studies on maxillary and mandibular nerve blocks have suggested benefit in maxillo-facial surgery but have been poorly investigated in orthognathic surgery. This study is designed to evaluate analgesic effectiveness, through opioids consumption, of a bilateral double ultra-sound guided nerve blocks (maxillar and mandibular nerve) in maxillo-mandibular osteotomy.
Read the detailed description
Maxillo-mandibular osteotomy is a frequent but painful procedure in maxillo-facial surgery. It mostly requires opioids use which lead to well known side effects. Regional anesthesia has strongly modified post-surgical rehabilitation of many procedures. Maxillary nerve block has proved its efficiency on opioid consumption reduction in pediatric cleft palet surgery but has been rarely evaluated in orthognathic surgery. Mandibular nerve block has never been investigated in maxillo-mandibular osteotomy as well as benefit of bilateral ultra-sound guided technique to perform these nerve blocks. Consequently, this trial is designed to evaluate analgesic effectiveness of a double ultra-sound guided nerve blocks (maxillar and mandibular nerve) in maxillo-mandibular osteotomy.
This monocentric, single-blinded, randomized controled trial is designed with 2 groups of 25 patients receiving either bilateral double ultra-sound guided nerve block (maxillary and mandibular) with ROPIVACAINE 4.75mg/mL either local infiltration of LIDOCAINE 1% at incision sites by surgeon after general anesthesia induction during maxillo-mandibular osteotomy. Per et post-surgery anesthesic protocol and analgesia are standardized for both group. The main outcome corresponds to opioid consumption in MME of the first 24h after surgery. Follow-up occurs at 24h and 48h after end of surgery to assess analgesia, pain and opioid consumption.
- Conditions
- Pain, Post Operative, Regional Anesthesia
- Being tested
- bilateral ultra-sound guided maxillary and mandibular nerve blocks, Infiltration of Lidocaine 1%
- Keywords
- Orthognathic surgery, Maxillary-mandibular osteotomy, Double jaw osteotomy, Bimaxillary surgery, Maxillary nerve block, Mandibular nerve block, Regional anesthesia, Nerve blocks
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilateral ultra-sound guided maxillary and mandibular nerve blocksProcedure or surgery
Interventional group will receive bilateral ultra-sound guided maxillary and mandibular nerve block with ROPIVACAINE 4,75 mg/ml.
Infiltration of Lidocaine 1%Procedure or surgery
Intervention requiring the infiltration of LIDOCAINE 1% at incision sites by surgeon after general anesthesia induction during maxillo-mandibular osteotomy
| Study group | Role | What they receive |
|---|---|---|
| Loco Regional anesthesia (LRA) | Experimental | The LRA group is made up of patients benefiting from the V2 and V3 ultrasound-guided LRA technique without mucosal infiltration. Receives: Procedure: bilateral ultra-sound guided maxillary and mandibular nerve blocks |
| Infiltration | Active comparator | The "Infiltration" group is made up of patients who benefit from the infiltration technique by local anesthesia of the incision sites by the surgeon without recourse to ultrasound-guided LRA. Receives: Procedure: Infiltration of Lidocaine 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
The opioid consumption (in Morphine Milligram Equivalents) after the first 24 hours post-surgery.
The opioid consumption (in Morphine Milligram Equivalents ) after the first 24hours post-surgery.
Measured: 24 hours post-surgery
Secondary outcomes (7)
Opioid consumption in Morphine Milligram Equivalents after the first 48 hours post-surgery.
Evaluation of the total consumption of morphine equivalents (Oxycodone Hydrochloride) after the first 48 hours postoperative hour.
Measured: 48 hours post-surgery
Maximal pain (Numerical Rating Scale) in recovery room, at 24h after surgery.
Pain assessment by Simple Numerical Scale (ENS from 0 to 10) in the Postoperative Monitoring Room (maximum value) at the 24th postoperative hour
Measured: 24 hours after surgery
Maximal pain (Numerical Rating Scale) in recovery room, at 48 hours after surgery.
Pain assessment by Simple Numerical Scale (ENS from 0 to 10) in the Postoperative Monitoring Room (maximum value) at the 48th postoperative hour.
Measured: 48 hours after surgery
Incidence of opioid-Emergent Adverse Events [Safety and Tolerability]
Measuring the incidence rate of common side effects associated with morphine drugs
Measured: 3 days
Evaluation of preoperative anxiety and fear using Amsterdam Preoperative Anxiety and Information Scale on post-surgical pain
The patient's degree of pre-operative anxiety will be assessed using the Amsterdam Preoperative Anxiety and Information questionnaire in French Items are rated on a 5-point Likert scale ranging from 1 = "not at all" to 5 = "extremely"
Measured: pré-anesthesic visit (day -1 or day 0)
Evaluation of patient satisfaction about medical care
The patient's feelings and satisfaction with their care will be evaluated by completing the questionnaire The feeling and satisfaction is rated according to a scale of 5 categories as follows: None, Low, Medium, High and Very High
Measured: 3 days (maximum)
Incidence of regional anesthesia-Emergent Adverse Event [Safety and Tolerability]
Measuring the incidence rate of common side effects associated with regional anesthesia
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start23 May 2022
- Primary completion29 Mar 2023
- Study completion29 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, Post OperativeStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marion MURE, Ph, Principal investigator, University hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351151
- Sponsor's protocol ID
- RC31/21/0509
- Acronym
- ECHOMAX
- Status last verified
- Feb 2024
- First submitted
- 22 Apr 2022
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Esquerre T, Mure M, Minville V, Prevost A, Lauwers F, Ferre F. Bilateral ultrasound-guided maxillary and mandibular combined nerves block reduces morphine consumption after double-jaw orthognathic surgery: a randomized controlled trial. Reg Anesth Pain Med. 2025 Jul 4;50(7):575-580. doi: 10.1136/rapm-2024-105497.
PubMed 38697776
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Echoguided Maxillary and Mandibular Nerve Blocks in Planned Maxillomandibular Osteotomy Surgery
- ClinicalTrials.gov ID
- NCT05351151
- Acronym / sponsor ID
- ECHOMAX / RC31/21/0509
- Conditions
- Pain, Post Operative, Regional Anesthesia
- Keywords
- Orthognathic surgery, Maxillary-mandibular osteotomy, Double jaw osteotomy, Bimaxillary surgery, Maxillary nerve block, Mandibular nerve block, Regional anesthesia, Nerve blocks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 23 May 2022 (actual)
- Primary completion
- 29 Mar 2023 (actual)
- Study completion
- 29 Mar 2023 (actual)
- First posted
- 28 Apr 2022 (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.
Maxillo-mandibular osteotomy is a painful surgery which requires mostly opioids use. Recent studies on maxillary and mandibular nerve blocks have suggested benefit in maxillo-facial surgery but have been poorly investigated in orthognathic surgery. This study is designed to evaluate analgesic effectiveness, through opioids consumption, of a bilateral double ultra-sound guided nerve blocks (maxillar and mandibular nerve) in maxillo-mandibular osteotomy.
Detailed description
Maxillo-mandibular osteotomy is a frequent but painful procedure in maxillo-facial surgery. It mostly requires opioids use which lead to well known side effects. Regional anesthesia has strongly modified post-surgical rehabilitation of many procedures. Maxillary nerve block has proved its efficiency on opioid consumption reduction in pediatric cleft palet surgery but has been rarely evaluated in orthognathic surgery. Mandibular nerve block has never been investigated in maxillo-mandibular osteotomy as well as benefit of bilateral ultra-sound guided technique to perform these nerve blocks. Consequently, this trial is designed to evaluate analgesic effectiveness of a double ultra-sound guided nerve blocks (maxillar and mandibular nerve) in maxillo-mandibular osteotomy.
This monocentric, single-blinded, randomized controled trial is designed with 2 groups of 25 patients receiving either bilateral double ultra-sound guided nerve block (maxillary and mandibular) with ROPIVACAINE 4.75mg/mL either local infiltration of LIDOCAINE 1% at incision sites by surgeon after general anesthesia induction during maxillo-mandibular osteotomy. Per et post-surgery anesthesic protocol and analgesia are standardized for both group. The main outcome corresponds to opioid consumption in MME of the first 24h after surgery. Follow-up occurs at 24h and 48h after end of surgery to assess analgesia, pain and opioid consumption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Loco Regional anesthesia (LRA) | Experimental | Procedure: bilateral ultra-sound guided maxillary and mandibular nerve blocksThe LRA group is made up of patients benefiting from the V2 and V3 ultrasound-guided LRA technique without mucosal infiltration. |
| Infiltration | Active comparator | Procedure: Infiltration of Lidocaine 1%The "Infiltration" group is made up of patients who benefit from the infiltration technique by local anesthesia of the incision sites by the surgeon without recourse to ultrasound-guided LRA. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients from 15 to 45 years old,
- Scheduled for maxillary-mandibular osteotomy,
- Registered in French social insurance register,
- With informed consent disclosure.
Key exclusion criteria (13 listed)
- American Society of Anesthesiologists (ASA) classification ≥ 3
- Innate or acquired hemostasis pathology,
- Peripheric neuropathy,
- Drug intake for chronic pain,
- Infection/scar at needle insertion site,
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 |
|---|---|---|
| bilateral ultra-sound guided maxillary and mandibular nerve blocksInterventional group will receive bilateral ultra-sound guided maxillary and mandibular nerve block with ROPIVACAINE 4,75 mg/ml. | Procedure or surgery | Loco Regional anesthesia (LRA) |
| Infiltration of Lidocaine 1%Intervention requiring the infiltration of LIDOCAINE 1% at incision sites by surgeon after general anesthesia induction during maxillo-mandibular osteotomy | Procedure or surgery | Infiltration |
Primary outcome
The opioid consumption (in Morphine Milligram Equivalents) after the first 24 hours post-surgery.
Time frame: 24 hours post-surgery
The opioid consumption (in Morphine Milligram Equivalents ) after the first 24hours post-surgery.
7 secondary outcomes
Opioid consumption in Morphine Milligram Equivalents after the first 48 hours post-surgery.
Time frame: 48 hours post-surgery
Maximal pain (Numerical Rating Scale) in recovery room, at 24h after surgery.
Time frame: 24 hours after surgery
Maximal pain (Numerical Rating Scale) in recovery room, at 48 hours after surgery.
Time frame: 48 hours after surgery
Incidence of opioid-Emergent Adverse Events [Safety and Tolerability]
Time frame: 3 days
Evaluation of preoperative anxiety and fear using Amsterdam Preoperative Anxiety and Information Scale on post-surgical pain
Time frame: pré-anesthesic visit (day -1 or day 0)
Evaluation of patient satisfaction about medical care
Time frame: 3 days (maximum)
Incidence of regional anesthesia-Emergent Adverse Event [Safety and Tolerability]
Time frame: 3 days
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 28 Nov 2025.
- Results publication: PubMed 38697776Esquerre T, Mure M, Minville V, Prevost A, Lauwers F, Ferre F. Bilateral ultrasound-guided maxillary and mandibular combined nerves block reduces morphine consumption after double-jaw orthognathic surgery: a randomized controlled trial. Reg Anesth Pain Med. 2025 Jul 4;50(7):575-580. doi: 10.1136/rapm-2024-105497.
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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.
Marion MURE, Ph principal investigator
University hospital of Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bilateral ultra-sound guided maxillary and mandibular nerve blocks and Infiltration of Lidocaine 1% in people with Pain, Post Operative and Regional Anesthesia, run by University Hospital, Toulouse 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 4 inclusion and 13 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 28 Nov 2025. 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?
The opioid consumption (in Morphine Milligram Equivalents) after the first 24 hours post-surgery. (time frame: 24 hours post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05351151, which also lists 1 linked publication.
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 28 Nov 2025.