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Enrolling by invitationNCT05964868Updated Apr 3, 2026

Efficacy of Liposomal Bupivacaine Post Septorhinoplasty

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

Phase
Phase 3
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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 standard local anesthetic regimens.

Read the 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 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.

02

Conditions studied

  • Rhinoplasty
  • Pain Management

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Keywords

  • Narcotics
  • opioid
  • septorhinoplasty
  • pain
03

In context

Agnosia

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 →

Lead sponsor

This is the only study on the registry with Jessyka Lighthall as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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)

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
72 participants (estimated)

Study arms

  • Experimental
    Liposomal Bupivacaine

    This group will receive a one time 5 mL injection of liposomal bupivacaine post-operatively at the surgical site.

    Drug: Liposomal Bupivacaine

  • Active comparator
    Bupivacaine with epinephrine

    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

  • Placebo comparator
    Saline solution

    This group will receive a one-time 5 mL injection of saline post-operatively at the surgical site.

    Other: Placebo - Saline solution

Interventions

  • DrugLiposomal Bupivacaine

    Patients will receive post-operative liposomal bupivacaine (EXPAREL®) at the surgical site at the completion of their septorhinoplasty.

  • Drug0.25% bupivacaine with 1:200,000 epinephrine

    Non-liposomal encapsulated bupivacaine at the surgical site at the completion of septorhinoplasty.

  • OtherPlacebo - Saline solution

    This group will receive a one-time 5 mL injection of saline post-operatively at the surgical site.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Difference in breathing outcomes between placebo and test drug

    NOSE questionnaire minimum 0 no obstruction to 100 complete obstruction

    Time frame: 6 months

  4. Difference in adverse events/complications between placebo and test drug

    Assess for general adverse events and post-operative complications

    Time frame: 6 months

07

Study locations

1 site
  • Jessyka Lighthall
    Hershey, Pennsylvania 17033, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05964868
Lead sponsor
Jessyka Lighthall
Responsible party
Jessyka Lighthall (Chief, Division of Facial Plastic & Reconstructive Surgery, Milton S. Hershey Medical Center) — Sponsor-investigator
First posted
Jul 28, 2023
Start date
Feb 5, 2024
Primary completion
Dec 2026 (estimated)
Completion
Jul 2027 (estimated)
Last update
Apr 3, 2026

Study contacts

Jessyka Lighthall, MD
principal investigator · Penn State Health

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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