Clinical trial NCT06243263: Postoperative Pain After Bupivacaine Supplementation in Mandibular Fracture Surgery
Official title: Postoperative Pain After Bupivacaine Supplementation in Mandibular Fracture Surgery: a Double Blind Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Postoperative Pain
Mandible Fracture
Analgesia
Anesthesia, Local
Keywords: Mandibular Fracture, Postoperative pain, Inferior alveolar nerve block, Analgesia
Lead sponsor: University Tunis El Manar
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants with bifocal mandibular fractures will be enrolled in the study (a fracture should be located on the dentate portion of the right hemi-mandible, and a second fracture located on the dentate portion of the left hemi-mandible). Each patient will receive either a right or left inferior alveolar nerve block with bupivacaine.
Primary purpose: PREVENTION

Brief summary: Pain following open reduction of mandibular fractures is the most reported complaint during the first 24 post-operative hours. The goal of this clinical trial is to evaluate the impact of inferior alveolar nerve block with bupivacaine 0,5% in patients with mandibular fractures.

The main question it aims to answer are:

* Does the inferior alveolar nerve block with bupivacaine reduce the intensity of pain after mandibular fracture surgery?
* Does the inferior alveolar nerve block with bupivacaine decrease the consumption of analgesics during the first 24 postoperative hours?

Participants with bifocal mandibular fractures will be enrolled in the study (a fracture should be located on the dentate portion of the right hemi-mandible, and a second fracture located on the dentate portion of the left hemi-mandible). Each patient will receive either a right or left inferior alveolar nerve block.

The patient:

* Will be asked to estimate the pain score by the numerical rating scale during the first 24 postoperative hours for each fracture.
* They will be given rescue analgesia in case of intense pain. The number of uses of rescue analgesia will be noted.

Researchers will compare a group of fracture that will receive the inferior alveolar nerve block with bupivacaine with a group of fracture that will not receive the inferior alveolar nerve block, to see if regional anesthesia improve postoperative pain management of mandibular fractures.


Eligibility criteria: Inclusion Criteria:

* Patients with bifocal mandibular fractures ( with one fracture on the dentate portion of the right hemi-mandible, and a second fracture located on the dentate portion of the left hemi-mandible )
* Proposed for open reduction and internal fixation of their fractures under general anesthesia;
* Having provided their informed and documented consent on a consent form.

Exclusion Criteria:

* Pathological mandibular fractures;
* History of mandibular fractures;
* Patients with bone involvement in the facial skeleton other than the two fractures of the mandibular dentate portion;
* Patients suffering from trigeminal neuralgia;
* Dental care performed in the month preceding the trauma;
* Patients who have not undergone surgical treatment with open reduction and internal fixation of their mandibular fractures;
* Patients on anticoagulants;
* Porphyrias;
* History of malignant hyperthermia;
* Known allergy to local anesthetics;
* Pregnancy or breastfeeding;
* Severe heart failure;
* Atrioventricular conduction disorders;
* Uncontrolled epilepsy;
* Hemostatic disorders;
* Non-cooperative patients.

Primary outcomes:
measure: Post-operative pain
timeFrame: 8 hours post-operatively
Secondary outcomes:
measure: Post-operative pain
timeFrame: 2, 4 , 12, 24 hours post-operatively
measure: Adverse effects
timeFrame: 24 hours post-operatively
measure: The number of instances of rescue analgesia
timeFrame: 24 hours post-operatively
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Charles Nicole Hospital
city: Tunis
country: Tunisia
facility: Charles Nicolle Hospital of Tunis
Study officials:
References: