Pain Reduction in Maxillomandibular Surgery Using Maxillary and Mandibular Nerve Blocks

NCT05351151 | Completed

• 1 other identifier: RC31/21/0509
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• The opioid consumption (in Morphine Milligram Equivalents) after the first 24 hours post-surgery.

  The opioid consumption (in Morphine Milligram Equivalents ) after the first 24hours post-surgery.

  24 hours post-surgery

Secondary Outcomes (7)

• Opioid consumption in Morphine Milligram Equivalents after the first 48 hours post-surgery.

  48 hours post-surgery

• Maximal pain (Numerical Rating Scale) in recovery room, at 24h after surgery.

  24 hours after surgery

• Maximal pain (Numerical Rating Scale) in recovery room, at 48 hours after surgery.

  48 hours after surgery

• Incidence of opioid-Emergent Adverse Events [Safety and Tolerability]

  3 days

• Evaluation of preoperative anxiety and fear using Amsterdam Preoperative Anxiety and Information Scale on post-surgical pain

  pré-anesthesic visit (day -1 or day 0)

Study Arms (2)

Loco Regional anesthesia (LRA)

EXPERIMENTAL

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

Infiltration

ACTIVE COMPARATOR

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%

Interventions

bilateral ultra-sound guided maxillary and mandibular nerve blocks PROCEDURE

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

Loco Regional anesthesia (LRA)

Infiltration of Lidocaine 1% PROCEDURE

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

Infiltration

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital of Toulouse

Toulouse, 31100, France

Location

Related Publications (1)

• 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.

  PMID: 38697776 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Marion MURE, Ph

  University hospital of Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: April 28, 2022
• Study Start: May 23, 2022
• Primary Completion: March 29, 2023
• Study Completion: March 29, 2023
• Last Updated: November 28, 2025

Record last verified: 2024-02

Locations

FR (1)