Status:
ENROLLING_BY_INVITATION
Efficacy of Liposomal Bupivacaine Post Septorhinoplasty
Lead Sponsor:
Jessyka Lighthall
Conditions:
Rhinoplasty
Pain Management
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief Summary
The objective of this study is to determine if there is a difference in post-operative pain after septorhinoplasty when long-acting liposomal bupivacaine is used for local anesthesia compared to other...
Detailed Description
Hypothesis: Patients receiving postoperative liposomal bupivacaine (EXPAREL®) at the surgical site after their septorhinoplasty will have better postoperative pain control and require fewer narcotics ...
Eligibility Criteria
Inclusion
- Subject must be undergoing rhinoplasty or septorhinoplasty surgery
- Male or female subjects greater than or equal to 18 years of age
- Written informed consent must be obtained
Exclusion
- 2\. The subject is a pregnant or lactating 3. Patients have a cognitive impairment 4. Patient is a prisoner 5. Patients with hypersensitivity to local anesthetics and pain medications used in the study 6. Patients weighing less than 48 kg 7. Patients preoperatively taking narcotics for chronic pain 8. Patients with pre-existing painful conditions (complex regional pain syndrome, fibromyalgia, neuropathy) 9. Patients with liver dysfunction 10. Patients with increased creatinine (over 1.5 mg/dl) 11. Patients who have undergone autologous costal cartilage grafting with their rhinoplasty 12. Morbid obesity (BMI \>40)
Key Trial Info
Start Date :
February 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05964868
Start Date
February 5 2024
End Date
July 1 2027
Last Update
March 17 2025
Active Locations (1)
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1
Jessyka Lighthall
Hershey, Pennsylvania, United States, 17033