Pain control after nose surgery using a nerve block
Post-operative Pain Control With Sphenopalantine Ganglion Nerve Block in Septorhinoplasty Patients
PHASE4 · University of Florida · NCT05667324
This study is testing if a special nerve block can help reduce pain and the need for pain medication after nose surgery for people having septorhinoplasty.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Florida (other) |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT05667324 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a pterygopalatine fossa nerve block in reducing post-operative pain and opioid use in patients undergoing septorhinoplasty. It is a randomized, double-blinded, placebo-controlled study that will compare the outcomes of patients receiving the nerve block with those receiving a placebo. The study aims to determine if this technique can minimize pain and the associated morbidity following surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 undergoing open or endoscopic septorhinoplasty with an ASA physical classification of 1-3.
Not a fit: Patients with chronic pain conditions, ongoing opioid use, or those requiring additional surgeries will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce post-operative pain and reliance on opioids for patients undergoing septorhinoplasty.
How similar studies have performed: Previous studies have shown that nerve blocks can effectively reduce post-operative pain in similar surgical contexts, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient presenting for open or endoscopic septorhinoplasty * Age 18-80 * Normal oral food and water intake before surgery * ASA physical classification 1-3 Exclusion Criteria: * Refusal to consent * Patients without a cellular phone or who are unable to accept text messages * Allergy to opioid narcotics * ASA physical classification of 4 or higher * Patient requires other surgery in addition to septorhinoplasty * Age \> 80 or \<18 * Any underlying chronic pain condition or ongoing opioid use over the preceding 3 months * Presence of any other factor which, at the discretion of any member of the study team, makes the patient a poor candidate for block placement. * Presence of any other factor which, at the discretion of any member of the study team, makes the patient a poor candidate for research participation. * Pregnant women
Where this trial is running
Gainesville, Florida
- UF Health of University of Florida — Gainesville, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Jeffrey D Johnson, MD — University of Florida
- Study coordinator: Jeffrey D Johnson, MD
- Email: jeffrey.johnson@ent.ufl.edu
- Phone: 352-273-5199
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: Deviated Nasal Septum, Post-op pain, septorhinoplasty, deviated septum