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Completed

NCT Number: NCT05351151

Pain Reduction in Maxillomandibular Surgery Using Maxillary and Mandibular Nerve Blocks

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.

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Key information

Conditions

Pain, Post Operative Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Regional Anesthesia Signs and Symptoms

Age range

15 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Toulouse

Toulouse, 31100, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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

  5. 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"

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Analgesic Efficacy of Echoguided Maxillary and Mandibular Nerve Blocks in Planned Maxillomandibular Osteotomy Surgery

Acronym: ECHOMAX

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 28, 2022
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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