Clinical trial NCT05351151: Pain Reduction in Maxillomandibular Surgery Using Maxillary and Mandibular Nerve Blocks
Official title: Analgesic Efficacy of Echoguided Maxillary and Mandibular Nerve Blocks in Planned Maxillomandibular Osteotomy Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The opioid consumption (in Morphine Milligram Equivalents) after the first 24 hours post-surgery.
timeFrame: 24 hours post-surgery
Secondary outcomes:
measure: Opioid consumption in Morphine Milligram Equivalents after the first 48 hours post-surgery.
timeFrame: 48 hours post-surgery
measure: Maximal pain (Numerical Rating Scale) in recovery room, at 24h after surgery.
timeFrame: 24 hours after surgery
measure: Maximal pain (Numerical Rating Scale) in recovery room, at 48 hours after surgery.
timeFrame: 48 hours after surgery
measure: Incidence of opioid-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 3 days
measure: Evaluation of preoperative anxiety and fear using Amsterdam Preoperative Anxiety and Information Scale on post-surgical pain
timeFrame: pré-anesthesic visit (day -1 or day 0)
measure: Evaluation of patient satisfaction about medical care
timeFrame: 3 days (maximum)
measure: Incidence of regional anesthesia-Emergent Adverse Event [Safety and Tolerability]
timeFrame: 3 days
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: University hospital of Toulouse
name: Marion MURE, Ph
role: PRINCIPAL_INVESTIGATOR
References: