Assessing pain control methods in mandibular fracture surgeries
Is Inferior Alveolar Nerve Block Beneficial in Fracture Mandibular Surgeries? A Randomised Controlled Trial
This study is testing if adding a specific nerve block to regular pain medicine can help people having jaw surgery feel less pain and use fewer opioids.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06167187 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of adding a pre-emptive inferior alveolar nerve block to conventional intravenous analgesia for managing perioperative pain in patients undergoing fracture mandibular surgeries. The research aims to reduce reliance on opioid medications, which can lead to significant side effects such as ventilatory depression and nausea. By utilizing long-acting local anesthetics like bupivacaine, the study seeks to enhance pain management while minimizing complications associated with opioid use. Participants will receive either the nerve block or standard analgesia to compare outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 scheduled for fracture mandible fixation with an ASA Physical Status Class I to III.
Not a fit: Patients with a history of allergy to the study medications, contraindications to regional anesthesia, or psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management and reduce opioid-related side effects for patients undergoing mandibular surgeries.
How similar studies have performed: Previous studies have shown that regional anesthesia techniques, including nerve blocks, can effectively reduce opioid consumption and improve pain management in surgical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age group: 18 - 65 years old. 2. American Society of Anesthesiologists (ASA) Physical Status Class I to III 3. Scheduled for fracture mandible fixation. Exclusion Criteria: 1. Refusing to participate in the study. 2. History of allergy to the medications used in the study. 3. Contraindications to regional anesthesia (including coagulopathy and local infection). 4. Psychiatric disorders. 5. Pregnancy.
Where this trial is running
Cairo
- Faculty of medicine - Ain shams university hospitals — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Mohamed Atef, ass.lecturer — faculty of medicine, ain shams university
- Study coordinator: Mohamed Atef, ass.lecturer
- Email: Moahmed.Atef@med.asu.edu.eg
- Phone: 00201065270020
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.