Pain Reduction in Maxillomandibular Surgery Using Maxillary and Mandibular Nerve Blocks

Study Overview
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Brief Summary
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Maxillo-mandibular osteotomy is a painful surgery which requires mostly opioïds 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 opioïds consumption, of a bilateral double ultra-sound guided nerve blocks (maxillar and mandibular nerve) in maxillo-mandibular osteotomy.

Detailed Description
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Maxillo-mandibular osteotomy is a frequent but painful procedure in maxillo-facial surgery. It mostly requires opioïds 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 opioïd 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 contoled 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 opioïd 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 opioïd consumption.

Official Title
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Analgesic Efficacy of Echoguided Maxillary and Mandibular Nerve Blocks in Planned Maxillomandibular Osteotomy Surgery

Conditions
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Regional Anesthesia, Pain, Post Operative

Intervention / Treatment
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* Procedure: bilateral ultra-sound guided maxillary and mandibular nerve blocks
* Procedure: Infiltration of Lidocaine 1%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients from 15 to 45 years old, Scheduled for maxillary-mandibular osteotomy, Registred in French social insurance register, With informed consent disclosure. Exclusion Criteria: ASA ≥ 3 Inate or acquired hemostasis pathology, Periphireic neuropathy, Drug intake for chronic pain, Infection/scar at needle insertion site, Associated rhinoplasty surgery, Allergy to local anethetics, Pregnant woman or potentially, Breastfeeding woman, Already registred 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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regional anesthesia ALR<br>The ALR group is made up of patients benefiting from the V2 and V3 ultrasound-guided ALR technique without mucosal infiltration. | Procedure: bilateral ultra-sound guided maxillary and mandibular nerve blocks<br>* Interventional group will receive bilateral ultra-sound guided maxillary and mandibular nerve block with ROPIVACAINE 4,75 mg/ml.<br>|
| Active Comparator: Infiltration<br>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. | Procedure: Infiltration of Lidocaine 1%<br>* Intervention requiring the infiltration of LIDOCAINE 1% at incision sites by surgeon after general anesthesia induction during maxillo-mandibular osteotomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The opioïd consumption (in Morphine Milligram Equivalents) after the first 24 hours post-surgery. | The opioïd consumption (in Morphine Milligram Equivalents ) after the first 24hours post-surgery. | 24 hours post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioïd 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. | 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 | 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. | 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 | 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 | 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 | 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 | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Orthognathic surgery, Maxillary-mandibular osteotomy, Double jaw osteotomy, Bimaxillary surgery, Maxillary nerve block, Mandibular nerve block, Regional anesthesia, Nerve blocks