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

Primary Purpose

Pain, Post Operative, Regional Anesthesia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
bilateral ultra-sound guided maxillary and mandibular nerve blocks
Infiltration of Lidocaine 1%
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Post Operative focused on measuring Orthognathic surgery, Maxillary-mandibular osteotomy, Double jaw osteotomy, Bimaxillary surgery, Maxillary nerve block, Mandibular nerve block, Regional anesthesia, Nerve blocks

Eligibility Criteria

15 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital of ToulouseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Regional anesthesia "ALR"

Infiltration

Arm Description

The ALR group is made up of patients benefiting from the V2 and V3 ultrasound-guided ALR technique without mucosal 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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.
Incidence of opioid-Emergent Adverse Events [Safety and Tolerability]
Measuring the incidence rate of common side effects associated with morphine drugs
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"
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
Incidence of regional anesthesia-Emergent Adverse Event [Safety and Tolerability]
Measuring the incidence rate of common side effects associated with regional anesthesia

Full Information

First Posted
April 22, 2022
Last Updated
June 10, 2022
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT05351151
Brief Title
Pain Reduction in Maxillomandibular Surgery Using Maxillary and Mandibular Nerve Blocks
Acronym
ECHOMAX
Official Title
Analgesic Efficacy of Echoguided Maxillary and Mandibular Nerve Blocks in Planned Maxillomandibular Osteotomy Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Regional anesthesia "ALR"
Arm Type
Experimental
Arm Description
The ALR group is made up of patients benefiting from the V2 and V3 ultrasound-guided ALR technique without mucosal infiltration.
Arm Title
Infiltration
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
bilateral ultra-sound guided maxillary and mandibular nerve blocks
Intervention Description
Interventional group will receive bilateral ultra-sound guided maxillary and mandibular nerve block with ROPIVACAINE 4,75 mg/ml.
Intervention Type
Procedure
Intervention Name(s)
Infiltration of Lidocaine 1%
Intervention Description
Intervention requiring the infiltration of LIDOCAINE 1% at incision sites by surgeon after general anesthesia induction during maxillo-mandibular osteotomy
Primary Outcome Measure Information:
Title
The opioïd consumption (in Morphine Milligram Equivalents) after the first 24 hours post-surgery.
Description
The opioïd consumption (in Morphine Milligram Equivalents ) after the first 24hours post-surgery.
Time Frame
24 hours post-surgery
Secondary Outcome Measure Information:
Title
Opioïd consumption in Morphine Milligram Equivalents after the first 48 hours post-surgery.
Description
Evaluation of the total consumption of morphine equivalents (Oxycodone Hydrochloride) after the first 48 hours postoperative hour.
Time Frame
48 hours post-surgery
Title
Maximal pain (Numerical Rating Scale) in recovery room, at 24h after surgery.
Description
Pain assessment by Simple Numerical Scale (ENS from 0 to 10) in the Postoperative Monitoring Room (maximum value) at the 24th postoperative hour
Time Frame
24 hours after surgery
Title
Maximal pain (Numerical Rating Scale) in recovery room, at 48 hours after surgery.
Description
Pain assessment by Simple Numerical Scale (ENS from 0 to 10) in the Postoperative Monitoring Room (maximum value) at the 48th postoperative hour.
Time Frame
48 hours after surgery
Title
Incidence of opioid-Emergent Adverse Events [Safety and Tolerability]
Description
Measuring the incidence rate of common side effects associated with morphine drugs
Time Frame
3 days
Title
Evaluation of preoperative anxiety and fear using Amsterdam Preoperative Anxiety and Information Scale on post-surgical pain
Description
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"
Time Frame
pré-anesthesic visit (day -1 or day 0)
Title
Evaluation of patient satisfaction about medical care
Description
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
Time Frame
3 days (maximum)
Title
Incidence of regional anesthesia-Emergent Adverse Event [Safety and Tolerability]
Description
Measuring the incidence rate of common side effects associated with regional anesthesia
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marion MURE, Ph
Phone
05 61 77 95 91
Email
mure.m@chu-toulouse.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Esquerre
Email
esquerre.t@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marion MURE, Ph
Organizational Affiliation
University hospital of Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Toulouse
City
Toulouse
ZIP/Postal Code
31100
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Pain Reduction in Maxillomandibular Surgery Using Maxillary and Mandibular Nerve Blocks

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