Evaluating pain relief after surgery for mandibular fractures using bupivacaine
Postoperative Pain After Bupivacaine Supplementation in Mandibular Fracture Surgery: a Double Blind Controlled Clinical Trial
This study tests if using a specific pain relief method with bupivacaine can help people with certain jaw fractures feel less pain after surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University Tunis El Manar Academic / other |
| Locations | 2 sites (Tunis and 1 other locations) |
| Trial ID | NCT06243263 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of an inferior alveolar nerve block with bupivacaine 0.5% in reducing postoperative pain in patients undergoing surgery for bifocal mandibular fractures. The study aims to determine if this method decreases pain intensity and the need for additional analgesics during the first 24 hours post-surgery. Participants will receive either a right or left nerve block and will report their pain levels using a numerical rating scale. The trial focuses on patients with specific types of mandibular fractures requiring surgical intervention.
Who should consider this trial
Good fit: Ideal candidates are patients with bifocal mandibular fractures who are scheduled for open reduction and internal fixation under general anesthesia.
Not a fit: Patients with pathological mandibular fractures, a history of mandibular fractures, or those with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative pain and analgesic consumption for patients undergoing mandibular fracture surgery.
How similar studies have performed: Other studies have shown promising results with similar nerve block techniques, suggesting potential effectiveness in managing postoperative pain.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tunis and 1 other locations
- Charles Nicole Hospital — Tunis, Tunisia (Recruiting)
- Charles Nicolle Hospital of Tunis — Tunis, Tunisia (Completed)
Study contacts
- Study coordinator: yasmine sanaa, MD
- Email: yasmine.sanaa@gmail.com
- Phone: +21658330834
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.