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

Toulouse University Hospital

Status: Completed

Conditions: Pain, Post Operative; Regional Anesthesia

Treatments: Procedure: bilateral ultra-sound guided maxillary and mandibular nerve blocks; Procedure: Infiltration of Lidocaine 1%

Study type: Interventional

Funder types: Other

Identifiers

NCT05351151

RC31/21/0509

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 15 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

50 participants in 2 patient groups

Loco Regional anesthesia (LRA)

Experimental group

Description:

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

Treatment:

Procedure: bilateral ultra-sound guided maxillary and mandibular nerve blocks

Infiltration

Active Comparator group

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.

Treatment:

Procedure: Infiltration of Lidocaine 1%