The Efficacy of Liposomal Bupivacaine in the Management of Post-operative Pain Following Septorhinoplasty: A Single-blinded, Prospective Clinical Trial

STUDY00020710

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 standard local anesthetic regimens.

2024-02-05

2024-10-01

2024-12-01

Early phase I

72

Inclusion Criteria: 1. Subject must be undergoing rhinoplasty or septorhinoplasty surgery 2. Male or female subjects greater than or equal to 18 years of age 3. Written informed consent must be obtained Exclusion Criteria: 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)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This will be a randomized controlled, single-blinded study.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'The patient, surgeons, and research team will be blinded to the group that the subject was randomized to. The pharmacy will prepare equivalent drugs for each study group to visually appear similar so that blinding can be maintained. In the event if the patient experiences a concerning or an adverse reaction, the patient, the surgeons and the research team will be immediately unblinded from the study. If unblinding is required, the pharmacy will be notified and then will provide, from the randomization list, information as to which study group the patient was assigned.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 72, 'type': 'ESTIMATED'}}

2024-02-13