Efficacy of Liposomal Bupivacaine Post Septorhinoplasty

NCT05964868 | Enrolling By Invitation Phase 3 DMC FDA Drug

• 1 other identifier: STUDY00020710
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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 standard local anesthetic regimens.

Conditions

Rhinoplasty; Pain Management

Keywords

Narcotics; opioid; septorhinoplasty; pain

Outcome Measures

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

  6 months

Secondary Outcomes (4)

• 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

  6 months

• Difference in time to first dose of opioid rescue after surgery between placebo and test drug

  6 months

• Difference in breathing outcomes between placebo and test drug

  6 months

• Difference in adverse events/complications between placebo and test drug

  6 months

Study Arms (3)

Liposomal Bupivacaine

EXPERIMENTAL

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

Drug: Liposomal Bupivacaine

Bupivacaine with epinephrine

ACTIVE COMPARATOR

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

Saline solution

PLACEBO COMPARATOR

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

Other: Placebo - Saline solution

Interventions

Liposomal Bupivacaine DRUG

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

Liposomal Bupivacaine

0.25% bupivacaine with 1:200,000 epinephrine DRUG

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

Bupivacaine with epinephrine

Placebo - Saline solution OTHER

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

Saline solution

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \. 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)

Sponsors & Collaborators

• Jessyka Lighthall: lead

Study Sites (1)

Jessyka Lighthall

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Agnosia; Pain

Interventions

Bupivacaine; Epinephrine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Jessyka Lighthall, MD

  Penn State Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Division of Facial Plastic & Reconstructive Surgery

Model Details: This will be a randomized controlled, single-blinded study.

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 28, 2023
• Study Start: February 5, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 17, 2025

Record last verified: 2025-03

Locations

US (1)