Postoperative Pain After Bupivacaine Supplementation in Mandibular Fracture Surgery

Postoperative Pain Clinical Trial

Official title:

Postoperative Pain After Bupivacaine Supplementation in Mandibular Fracture Surgery: a Double Blind Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06243263
• Other study ID #: T00000228
• Status: Recruiting
• Phase: Phase 4
• Start date: February 6, 2024
• Est. completion date: March 4, 2024

Study information

• Verified date: February 2024
• Source: University Tunis El Manar
• Contact: yasmine sanaa, MD
• Phone: +21658330834
• Email: yasmine.sanaa[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 4, 2024
• Est. primary completion date: March 4, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia
• Anesthesia, Local
• Fractures, Bone
• Mandible Fracture
• Mandibular Fractures
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Bupivacain
At the end of the surgery, after wound closure, an inferior alveolar nerve block with 2ml bupivacaine 0,5 % will be realized.

Locations

Country	Name	City	State
Tunisia	Charles Nicole Hospital	Tunis
Tunisia	Charles Nicolle Hospital of Tunis	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
University Tunis El Manar

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pain	questionnaire with a numerical scale (0 - 10)	8 hours post-operatively
Secondary	Post-operative pain	questionnaire with a numerical scale (0 - 10)	2, 4 , 12, 24 hours post-operatively
Secondary	Adverse effects	questionnaire including the presence or absence of any abnormal sensations, change in taste, nausea, constipation, fever, diaphoresis, vomiting, light-headedness, palpitations, or headache. The notice of an hematoma or in infection at the site of the injection	24 hours post-operatively
Secondary	The number of instances of rescue analgesia	We will record the number of instances of rescue analgesia following the description of intense pain for each hemi-mandible group.	24 hours post-operatively