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Pain, PostoperativePhase 2NCT07689162

Liposomal Bupivacaine vs Standard Bupivacaine for Post-Rhinoplasty Analgesia

A Phase 2 study testing Standard Bupivacaine and Liposomal Bupivacaine in people with Pain, Postoperative, run by Washington University School of Medicine at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Postoperative
What is being tested?
Standard Bupivacaine and Liposomal Bupivacaine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteUnited States
Study dates
1 Aug 2026to Jul 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Matthew Wu, MD contact

314-362-0524

mjwu@wustl.edu

Sara Kukuljan, BS, RN contact

314-362-7563

kukuljas@wustl.edu

United States1 site, 1 recruiting
  • Washington University

    St Louis, Missouri, 63110

    Sara Kukuljan, BS, RN, 314-362-7563, kukuljas@wustl.edu

    Recruiting

Other trials in United States

About this study

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

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

Read the detailed description

The investigators 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.

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

Being tested
Standard Bupivacaine, Liposomal Bupivacaine
Keywords
Otolaryngology, Rhinoplasty, Bupivacaine, Liposomal Bupivacaine
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard BupivacaineDrug

    Also called Marcaine

    Volume: 4 mL of 0.75% bupivacaine hydrochloride

  • Liposomal BupivacaineDrug

    Also called Exparel

    Volume: 1.5 mL of 0.75% bupivacaine hydrochloride and 2.5 mL of liposomal bupivacaine

Study groups in NCT07689162
Study groupRoleWhat they receive
Liposomal BupivacaineExperimentalParticipants randomized to the experimental arm will receive bilateral supraorbital and infraorbital nerve blocks using liposomal bupivacaine at the end of surgery.
Receives: Drug: Liposomal Bupivacaine
Standard BupivacaineActive comparatorThe control arm will receive standard bupivacaine nerve blocks using the same injection sites and volumes appropriate for safe regional anesthesia
Receives: Drug: Standard Bupivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative opioid consumption

    Cumulative opioid consumption in the first 72 post-operative hours expressed in morphine milligram equivalents (MME).

    Measured: First 72 hours postoperatively

Secondary outcomes (11)
  1. Modified Brief Pain Inventory - Pain Outcomes

    Patient-reported pain intensity and pain interference measured using the Modified Brief Pain Inventory (mBPI). Pain intensity is assessed with 3 items (average, current, and worst pain over the last 24 hours) and pain interference with 3 items (general activity, mood, and sleep). Each item is rated on a 0 to 10 numeric rating scale (0 = no pain / does not interfere; 10 = worst pain imaginable / completely interferes). Higher scores indicate a worse outcome.

    Measured: Postoperative day 0 through postoperative day 7

  2. Modified Brief Pain Inventory - Pain relief from analgesic medication

    Patient-reported relief from pain medication, measured using the corresponding item of the Modified Brief Pain Inventory (mBPI). The item is rated on a 0 to 10 numeric rating scale (0 = no relief; 10 = complete relief). Higher scores indicate a better outcome (greater pain relief).

    Measured: Postoperative day 0 through postoperative day 7

  3. Nausea

    Incidence of nausea, an opioid-related symptom, defined as the percentage of participants reporting any nausea on daily postoperative self-report surveys. Nausea is captured on a 0 to 10 rating and dichotomized as present (score ≥ 1) or absent (score 0) for this outcome. Reported as the percentage of participants (0% to 100%); a higher percentage indicates a worse outcome.

    Measured: Postoperative day 0 through postoperative day 7

  4. Vomiting

    Incidence of vomiting, an opioid-related symptom assessed via daily postoperative patient self-report surveys.

    Measured: Postoperative day 0 through postoperative day 7

  5. Constipation

    Incidence of constipation, an opioid-related symptom assessed via daily postoperative patient self-report surveys.

    Measured: Postoperative day 0 through postoperative day 7

  6. Rash

    Incidence of rash, an opioid-related symptom assessed via daily postoperative patient self-report surveys.

    Measured: Postoperative day 0 through postoperative day 7

  7. Adherence to ERAS Multimodal Analgesic Regimen

    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%.

    Measured: Postoperative day 0 through postoperative day 7

  8. Block site safety

    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.

    Measured: Preoperative baseline and one month postoperatively

  9. Adverse Events

    Capturing any adverse events classified according to prespecified criteria described in the protocol.

    Measured: Postoperative day 0 through one month postoperatively

  10. Standardized Cosmesis and Health Nasal Outcomes Survey - Obstruction

    Patient-reported nasal obstruction measured using the obstruction domain of the Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS-O). The obstruction domain score is normalized to a 0 to 100 scale, where higher scores indicate a worse outcome (greater nasal obstruction). Scores obtained preoperatively and at one month postoperatively will be compared to assess short-term postoperative changes.

    Measured: Preoperative baseline and one month postoperatively

  11. Standardized Cosmesis and Health Nasal Outcomes Survey - Cosmesis

    Patient-reported cosmesis measured using the cosmesis domain of the Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS-C). The cosmesis domain score is normalized to a 0 to 100 scale, where higher scores indicate a worse outcome (greater dissatisfaction with nasal appearance). Scores obtained preoperatively and at one month postoperatively will be compared to assess short-term postoperative changes.

    Measured: Preoperative baseline and one month postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2026
  2. Study start1 Aug 2026
  3. Primary completionJun 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is a single-site, prospective, randomized, single-blinded clinical trial
Masking
Single blind
Who is masked
Participant
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07689162
Sponsor's protocol ID
202601024
Status last verified
Aug 2026
First submitted
30 Jun 2026
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Justicz N, Gadkaree SK, Yamasaki A, Lindsay RW. Defining Typical Acetaminophen and Narcotic Usage in the Postoperative Rhinoplasty Patient. Laryngoscope. 2021 Jan;131(1):48-53. doi: 10.1002/lary.28531. Epub 2020 Feb 7.

    PubMed 32031696
  • Sclafani AP, Kim M, Kjaer K, Kacker A, Tabaee A. Postoperative pain and analgesic requirements after septoplasty and rhinoplasty. Laryngoscope. 2019 Sep;129(9):2020-2025. doi: 10.1002/lary.27913. Epub 2019 Mar 7.

    PubMed 30843623
  • Ilfeld BM, Viscusi ER, Hadzic A, Minkowitz HS, Morren MD, Lookabaugh J, Joshi GP. Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):572-82. doi: 10.1097/AAP.0000000000000283.

    PubMed 26204387
  • Alameddine KO, Richards BA, Vyas K, Chaudhry A, Millesi E, Hamilton GS, Bite U. Evaluating the Efficacy of Liposomal Bupivacaine in Postoperative Pain Management for Rhinoplasty: A Retrospective Study. Aesthetic Plast Surg. 2024 May;48(9):1722-1727. doi: 10.1007/s00266-023-03656-w. Epub 2023 Sep 29.

    PubMed 37775576
  • Ye Q, Asherman J, Stevenson M, Brownson E, Katre NV. DepoFoam technology: a vehicle for controlled delivery of protein and peptide drugs. J Control Release. 2000 Feb 14;64(1-3):155-66. doi: 10.1016/s0168-3659(99)00146-7.

    PubMed 10640654
  • Richard BM, Rickert DE, Newton PE, Ott LR, Haan D, Brubaker AN, Cole PI, Ross PE, Rebelatto MC, Nelson KG. Safety Evaluation of EXPAREL (DepoFoam Bupivacaine) Administered by Repeated Subcutaneous Injection in Rabbits and Dogs: Species Comparison. J Drug Deliv. 2011;2011:467429. doi: 10.1155/2011/467429. Epub 2011 Oct 5.

    PubMed 22013534
  • McAlvin JB, Padera RF, Shankarappa SA, Reznor G, Kwon AH, Chiang HH, Yang J, Kohane DS. Multivesicular liposomal bupivacaine at the sciatic nerve. Biomaterials. 2014 May;35(15):4557-64. doi: 10.1016/j.biomaterials.2014.02.015. Epub 2014 Mar 6.

    PubMed 24612918
  • Teunkens A, Vermeulen K, Van Gerven E, Fieuws S, Van de Velde M, Rex S. Comparison of 2-Chloroprocaine, Bupivacaine, and Lidocaine for Spinal Anesthesia in Patients Undergoing Knee Arthroscopy in an Outpatient Setting: A Double-Blind Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):576-83. doi: 10.1097/AAP.0000000000000420.

    PubMed 27281722
  • Marchand GJ, Masoud AT, Ware K, King A, Ruther S, Brazil G, Cieminski K, Calteux N, Coriell C, Ulibarri H, Parise J, Arroyo A, Chen YC, Pierson M, Rafie R, Sainz K. A Systematic Review and Meta-Analysis of the Effect of Intraoperative Bupivacaine in Gynaecologic Surgery After 24 Hours or 9 Half-Lives. J Obstet Gynaecol Can. 2021 Nov;43(11):1279-1287. doi: 10.1016/j.jogc.2021.06.010. Epub 2021 Jul 19.

    PubMed 34293514
  • Safa B, Flynn B, McHardy PG, Kiss A, Haslam L, Henry PD, Kaustov L, Choi S. Comparison of the Analgesic Duration of 0.5% Bupivacaine With 1:200,000 Epinephrine Versus 0.5% Ropivacaine Versus 1% Ropivacaine for Low-Volume Ultrasound-Guided Interscalene Brachial Plexus Block: A Randomized Controlled Trial. Anesth Analg. 2021 Apr 1;132(4):1129-1137. doi: 10.1213/ANE.0000000000005373.

    PubMed 33464760
  • The Efficacy of Liposomal Bupivacaine in the Management of Post-operative Pain Following Septorhinoplasty: a Single-blinded, Prospective Clinical Trial. National Library of Medicine (US). https://clinicaltrials.gov/study/NCT05964868

  • Dasta J, Ramamoorthy S, Patou G, Sinatra R. Bupivacaine liposome injectable suspension compared with bupivacaine HCl for the reduction of opioid burden in the postsurgical setting. Curr Med Res Opin. 2012 Oct;28(10):1609-15. doi: 10.1185/03007995.2012.721760. Epub 2012 Sep 3.

    PubMed 22900785
  • FDA. EXPAREL- bupivacaine injection, suspension, liposomal. FDA2024

  • FDA. MARCAINE - bupivacaine hydrochloride injection, solution. 2012.

  • Rosenberg PH, Veering BT, Urmey WF. Maximum recommended doses of local anesthetics: a multifactorial concept. Reg Anesth Pain Med. 2004 Nov-Dec;29(6):564-75; discussion 524. doi: 10.1016/j.rapm.2004.08.003.

    PubMed 15635516

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Standard Bupivacaine and Liposomal Bupivacaine in people with Pain, Postoperative, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Matthew Wu, MD (314-362-0524, mjwu@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative opioid consumption (time frame: First 72 hours postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07689162, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.

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