Pain Reduction in Maxillomandibular Surgery Using Maxillary and Mandibular Nerve Blocks (ECHOMAX)

November 21, 2025 updated by: University Hospital, Toulouse

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31100
        • University Hospital of Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients from 15 to 45 years old,
  • Scheduled for maxillary-mandibular osteotomy,
  • Registered in French social insurance register,
  • With informed consent disclosure.

Exclusion Criteria:

  • 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,
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal pain (Numerical Rating Scale) in recovery room, at 24h after surgery.
Time Frame: 24 hours 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.
Time Frame: 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]
Time Frame: 3 days
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
Time Frame: pré-anesthesic visit (day -1 or day 0)
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
Time Frame: 3 days (maximum)
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]
Time Frame: 3 days
Measuring the incidence rate of common side effects associated with regional anesthesia
3 days
Opioid consumption in Morphine Milligram Equivalents after the first 48 hours post-surgery.
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Marion MURE, Ph, University Hospital of Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2022

Primary Completion (Actual)

March 29, 2023

Study Completion (Actual)

March 29, 2023

Study Registration Dates

First Submitted

April 22, 2022

First Submitted That Met QC Criteria

April 22, 2022

First Posted (Actual)

April 28, 2022

Study Record Updates

Last Update Posted (Actual)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 21, 2025

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/21/0509

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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