Pain Reduction in Maxillomandibular Surgery Using Maxillary and Mandibular Nerve Blocks

Regional Anesthesia Clinical Trial

— ECHOMAX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05351151
• Other study ID #: RC31/21/0509
• Status: Completed
• Phase: N/A
• Start date: May 23, 2022
• Est. completion date: March 29, 2023

Study information

• Verified date: February 2024
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 29, 2023
• Est. primary completion date: March 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Post Operative
• Pain, Postoperative
• Regional Anesthesia

Intervention

Procedure:
• 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.
• Infiltration of Lidocaine 1%
Intervention requiring the infiltration of LIDOCAINE 1% at incision sites by surgeon after general anesthesia induction during maxillo-mandibular osteotomy

Locations

Country	Name	City	State
France	University Hospital of Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Opioid consumption in Morphine Milligram Equivalents after the first 48 hours post-surgery.	Evaluation of the total consumption of morphine equivalents (Oxycodone Hydrochloride) after the first 48 hours postoperative hour.	48 hours post-surgery
Secondary	Maximal pain (Numerical Rating Scale) in recovery room, at 24h 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	24 hours after surgery
Secondary	Maximal pain (Numerical Rating Scale) in recovery room, at 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.	48 hours after surgery
Secondary	Incidence of opioid-Emergent Adverse Events [Safety and Tolerability]	Measuring the incidence rate of common side effects associated with morphine drugs	3 days
Secondary	Evaluation of preoperative anxiety and fear using Amsterdam Preoperative Anxiety and Information Scale on post-surgical pain	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"	pré-anesthesic visit (day -1 or day 0)
Secondary	Evaluation of patient satisfaction about medical care	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	3 days (maximum)
Secondary	Incidence of regional anesthesia-Emergent Adverse Event [Safety and Tolerability]	Measuring the incidence rate of common side effects associated with regional anesthesia	3 days