Liposomal Bupivacaine vs Standard Bupivacaine for Post-Rhinoplasty Analgesia

June 30, 2026 updated by: Washington University School of Medicine

Liposomal Bupivacaine vs Standard Bupivacaine for Post-Rhinoplasty Analgesia: A Randomized Clinical Trial

The purpose of our study is to find out which pain medication is more effective in reducing pain after nose surgery(rhinoplasty). We are looking to find the best treatment to reduce discomfort and improve the healing process for patients having nose surgery.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

We are comparing two types of pain relief medications: Liposomal Bupivacaine and Standard Bupivacaine.

Participants who are undergoing rhinoplasty will be randomly assigned to receive either Liposomal Bupivacaine or Standard Bupivacaine during their surgery.

Both medications are given as nerve blocks, which means they are injected near nerves to block pain signals. After the surgery, participants will be asked to rate their pain levels over several days.

We will also monitor any side effects and how quickly participants recover from the surgery.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Matthew Wu, MD
  • Phone Number: 314-362-0524
  • Email: mjwu@wustl.edu

Study Contact Backup

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients (≥18 years) undergoing open rhinoplasty of any indication or complexity (e.g., primary, revision, functional, or cosmetic), including autologous grafting of any type (e.g., septal or costal cartilage) or cadaveric grafting.

Exclusion Criteria:

  • Chronic pain condition requiring ongoing or scheduled analgesic therapy, or any diagnosis associated with chronic pain (e.g., fibromyalgia, chronic headache/migraine, neuropathic pain, complex regional pain syndrome), long-term opioid use (≥3 months, any agent), allergy or contraindication to local anesthetics, acetaminophen, ibuprofen / NSAIDs, tramadol, ketamine, Medrol (methylprednisolone) dose pack
  • Concurrent non-nasal surgery planned

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liposomal Bupivacaine
Participants randomized to the experimental arm will receive bilateral supraorbital and infraorbital nerve blocks using liposomal bupivacaine at the end of surgery.
Drug: Liposomal Bupivacaine
Volume: 1.5 mL of 0.75% bupivacaine hydrochloride and 2.5 mL of liposomal bupivacaine
Other Names:
  • Exparel
Active Comparator: Standard Bupivacaine
The control arm will receive standard bupivacaine nerve blocks using the same injection sites and volumes appropriate for safe regional anesthesia
Drug: Standard Bupivacaine
Volume: 4 mL of 0.75% bupivacaine hydrochloride
Other Names:
  • Marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative opioid consumption
Time Frame: First 72 hours postoperatively
Cumulative opioid consumption in the first 72 post-operative hours expressed in morphine milligram equivalents (MME).
First 72 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Brief Pain Inventory
Time Frame: Postoperative day 0 through postoperative day 7
Patient-reported pain intensity and pain interference measured using the Modified Brief Pain Inventory (mBPI). Daily surveys will be used to assess pain severity and interference with function.
Postoperative day 0 through postoperative day 7
Nausea
Time Frame: Postoperative day 0 through postoperative day 7
Incidence of nausea, an opioid-related symptom assessed via daily postoperative patient self-report surveys.
Postoperative day 0 through postoperative day 7
Vomiting
Time Frame: Postoperative day 0 through postoperative day 7
Incidence of vomiting, an opioid-related symptom assessed via daily postoperative patient self-report surveys.
Postoperative day 0 through postoperative day 7
Constipation
Time Frame: Postoperative day 0 through postoperative day 7
Incidence of constipation, an opioid-related symptom assessed via daily postoperative patient self-report surveys.
Postoperative day 0 through postoperative day 7
Rash
Time Frame: Postoperative day 0 through postoperative day 7
Incidence of rash, an opioid-related symptom assessed via daily postoperative patient self-report surveys.
Postoperative day 0 through postoperative day 7
Adherence to ERAS Multimodal Analgesic Regimen
Time Frame: Postoperative day 0 through postoperative day 7
Patient adherence to the Enhanced Recovery After Surgery (ERAS) multimodal analgesic regimen, assessed using daily postoperative surveys, calculated as total number of pills taken / total number of pills prescribed x 100, with adherence defined as ≥80%.
Postoperative day 0 through postoperative day 7
Block site safety
Time Frame: Preoperative baseline and one month postoperatively
Proportion of participants with ≥1 new-onset injection-site or sensory adverse event, assessed by a 10-item binary patient-reported questionnaire at the supraorbital and infraorbital block sites. New-onset defined as negative at baseline and positive at follow-up.
Preoperative baseline and one month postoperatively
Adverse Events
Time Frame: Postoperative day 0 through one month postoperatively
Capturing any adverse events classified according to prespecified criteria described in the protocol.
Postoperative day 0 through one month postoperatively
Standardized Cosmesis and Health Nasal Outcomes Survey - Obstruction
Time Frame: Preoperative baseline and one month postoperatively

Patient-reported functional outcomes measured using the Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS). The SCHNOS includes functional (nasal obstruction and breathing-related symptoms) and aesthetic satisfaction domains.

Scores obtained preoperatively and at one month postoperatively will be compared to assess short-term postoperative changes.
Preoperative baseline and one month postoperatively
Standardized Cosmesis and Health Nasal Outcomes Survey - Cosmesis
Time Frame: Preoperative baseline and one month postoperatively

Patient-reported cosmesis outcome measured using the Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS). The SCHNOS includes functional (nasal obstruction and breathing-related symptoms) and aesthetic satisfaction domains.

Scores obtained preoperatively and at one month postoperatively will be compared to assess short-term postoperative changes.
Preoperative baseline and one month postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Matthew Wu, MD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

June 30, 2026

First Submitted That Met QC Criteria

June 30, 2026

First Posted (Actual)

July 8, 2026

Study Record Updates

Last Update Posted (Actual)

July 8, 2026

Last Update Submitted That Met QC Criteria

June 30, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202601024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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