Pain Reduction in Maxillomandibular Surgery Using Maxillary and Mandibular Nerve Blocks

NCT ID: NCT05351151

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-23
• Study Completion Date: 2023-03-29

Brief 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. 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.

Conditions

Pain, Post Operative; Regional Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

bilateral ultra-sound guided maxillary and mandibular nerve blocks

Intervention Type: PROCEDURE

Interventional group will receive bilateral ultra-sound guided maxillary and mandibular nerve block with ROPIVACAINE 4,75 mg/ml.

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.

Group Type: ACTIVE_COMPARATOR

Infiltration of Lidocaine 1%

Intervention Type: PROCEDURE

Intervention requiring the infiltration of LIDOCAINE 1% at incision sites by surgeon after general anesthesia induction during maxillo-mandibular osteotomy

Interventions

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.

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marion MURE, Ph

Role: PRINCIPAL_INVESTIGATOR

University hospital of Toulouse

Locations

University Hospital of Toulouse

Toulouse, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 38697776 (View on PubMed)

Other Identifiers

RC31/21/0509

Identifier Type: -

Identifier Source: org_study_id