Using a nerve block to manage pain and swelling in jaw surgery
The Effect of Sphenopalatine Ganglion Block on Intraoperative Analgesia, Postoperative Edema, and Pain in Bimaxillary Orthognathic Surgery
NA · Bezmialem Vakif University · NCT06933680
This study is testing if a special nerve block can help adults aged 18 to 45 have less pain and swelling after jaw surgery compared to a placebo treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Bezmialem Vakif University (other) |
| Locations | 1 site (Istanbul, Fatih) |
| Trial ID | NCT06933680 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of sphenopalatine ganglion (SPG) block in controlling intraoperative pain and reducing postoperative swelling in adults undergoing bimaxillary orthognathic surgery. Participants aged 18 to 45 will be randomly assigned to receive either an SPG block or a sham block before their surgery. The study aims to compare pain levels, opioid use, and swelling between the two groups over a one-month postoperative period. By assessing these outcomes, researchers hope to determine if the SPG block can improve recovery and reduce complications associated with the surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 45 who require bimaxillary orthognathic surgery and have an ASA score of I-II.
Not a fit: Patients with local anesthetic allergies, chronic pain, or certain medical conditions such as diabetes or bleeding disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance pain management and reduce recovery time for patients undergoing jaw surgery.
How similar studies have performed: While the use of SPG blocks for pain management is promising, this specific application in bimaxillary orthognathic surgery is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with bimaxillary orthognathic surgery indication * Patients with American Society of Anesthesiologistsscores (ASA) I-II * Patients between the ages of 18-45 Exclusion Criteria: * Patients with local anesthetic allergy * Patients undergoing genioplasty * Syndromes associated with secondary deformities in addition to jaw deformities * Patients with a history of jaw surgery * Patients with uncontrolled hypertension * Patients with a history of substance abuse * Patients with chronic pain lasting more than 3 months * Patients using analgesic and hypnotic agents for more than 2 weeks * Recent situations that may cause facial edema (tooth extraction, facial trauma, etc.) * Patients with psychiatric disorders * Patients with diabetes mellitus * Patients with bleeding disorders
Where this trial is running
Istanbul, Fatih
- Bezmialem Vakıf Üniversitesi — Istanbul, Fatih, Turkey (Türkiye) (RECRUITING)
Study contacts
- Principal investigator: Büşra Ceylan, Resident Doctor — Bezmialem Vakıf Üniversitesi
- Study coordinator: Büşra Ceylan, Resident Doctor
- Email: bcalis@bezmialem.edu.tr
- Phone: +905058945208
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.
Conditions: Bimaxillar Surgery, Sphenopalatine Ganglion Block, sphenopalatine ganglion block, pain, bimaxillary orthognathic surgery, edema, swelling