A Phase 3 interventional study of Liposomal Bupivacaine and 0.25% bupivacaine with 1:200,000 epinephrine in Rhinoplasty and Pain Management, sponsored by Jessyka Lighthall. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-03.
Sponsored by Jessyka Lighthall · Phase 3, Interventional, and Treatment
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.
Hypothesis: Patients receiving postoperative liposomal bupivacaine (EXPAREL®) at the surgical site after their septorhinoplasty will have better postoperative pain control and require fewer narcotics by means of a lower MME compared to the placebo group and the group that receives postoperative 0.25% bupivacaine with 1:200,000 epinephrine.
This a prospective randomized controlled, single-blind study evaluating the efficacy of EXPAREL® versus plain bupivacaine HCl and placebo after perinasal injections during septorhinoplasty procedures. Seventy-two total patients undergoing septorhinoplasty will be randomly distributed into three groups (20 patients per group) with various postoperative local anesthesia regimens. All groups will be given standard oral postoperative pain regimens as prescribed by the primary surgeon, typically consisting of alternating doses of 1000 mg acetaminophen and 800 mg ibuprofen with oxycodone 5 mg every 6 hours as needed for breakthrough pain. All three groups will receive the same treatment at the beginning of surgery with pre-incisional local surgical site injections with perinasal blocks of 1% lidocaine with 1:100,000 epinephrine. Group one (study group) will receive a five mL injection of EXPAREL® postoperatively, group two will receive a five mL injection of 0.25% bupivacaine with 1:200,000 epinephrine postoperatively, and group three will receive a five mL injection of saline along the surgical site, all in a ring block fashion (see illustration). This ring block involves nerve blocks to nasal branches of the supratrochlear, infraorbital, and infratrochlear nerves. This will also be injected into the floor of the nasal cavity to block branches of the nasopalatine nerve. The remainder of the ring block targets local infiltration surrounding the nose and injections are over bone. Although there is a potential risk of diffusion to adjacent cartilage, this risk is predicted to be low. Their use of postoperative pain medications will then be documented in the immediate postoperative period in the post-anesthesia care unit (PACU) as well as the following week postoperatively, every day, for three times a day. All groups will be required to fill electronic pain journals through RedCap (a HIPPA compliant server) to record consumption of pain medications and pain levels as reported by visual analog pain scales, the Wong-Baker FACES pain rating scale, and modified McGill pain questionnaire, all of which are validated tools for pain assessment. Patients will be subsequently followed over the course of six months postoperatively with these validated measures, use of pain medication, and by clinical exam of the nose/injection site including both external and internal nasal exam, palpation of the nose and cartilage grafts, evaluation static and dynamic function of the nose, and the presence of any adverse outcomes including but not limited to cartilage graft loss, septal perforation, synechiae formation, infection, and persistent or worsening nasal obstruction.
1,190 studies on the registry are indexed under Agnosia; 508 are open to participants now.
This study's planned enrollment of 72 is close to the median of 78 across 1,024 interventional studies indexed under Agnosia.
Browse Agnosia studies →This is the only study on the registry with Jessyka Lighthall as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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)
This group will receive a one time 5 mL injection of liposomal bupivacaine post-operatively at the surgical site.
Drug: Liposomal Bupivacaine
This group will receive a one-time 5 mL injection of 0.25% bupivacaine with 1:200,000 epinephrine post-operatively at the surgical site.
Drug: 0.25% bupivacaine with 1:200,000 epinephrine
This group will receive a one-time 5 mL injection of saline post-operatively at the surgical site.
Other: Placebo - Saline solution
Patients will receive post-operative liposomal bupivacaine (EXPAREL®) at the surgical site at the completion of their septorhinoplasty.
Non-liposomal encapsulated bupivacaine at the surgical site at the completion of septorhinoplasty.
This group will receive a one-time 5 mL injection of saline post-operatively at the surgical site.
Differences in postoperative milligram morphine equivalents (MME) used between placebo and liposomal bupivacaine
Convert amount of opioid ingested to MMEs as an objective measure of post-operative narcotic use
Time frame: 6 months
Different in patient reported outcome measure of subjective pain scores based on a validated visual analog pain scale (subjective measure) between placebo and test drug
Validated universal pain assessment tool: Wong-Baker pain scale pain questionnaire. Min 0 = no pain to 10 = maximum pain
Time frame: 6 months
Difference in time to first dose of opioid rescue after surgery between placebo and test drug
measure the time from leaving surgery to when the first dose of opioid is taken
Time frame: 6 months
Difference in breathing outcomes between placebo and test drug
NOSE questionnaire minimum 0 no obstruction to 100 complete obstruction
Time frame: 6 months
Difference in adverse events/complications between placebo and test drug
Assess for general adverse events and post-operative complications
Time frame: 6 months
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.