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NCT Number: NCT07689162

Liposomal Bupivacaine vs Standard Bupivacaine for Post-Rhinoplasty Analgesia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Bupivacaine

Drug

Volume: 4 mL of 0.75% bupivacaine hydrochloride

Other names: Marcaine

Liposomal bupivacaine

Drug

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

Other names: Exparel

Primary outcomes

  1. 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).

Secondary outcomes

  1. Modified Brief Pain Inventory - Pain Outcomes

    Time frame: Postoperative day 0 through postoperative day 7

    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.

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

    Time frame: Postoperative day 0 through postoperative day 7

    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).

  3. Nausea

    Time frame: Postoperative day 0 through postoperative day 7

    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.

  4. 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.

  5. 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.

  6. 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.

  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%.

  8. 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.

  9. Adverse Events

    Time frame: Postoperative day 0 through one month postoperatively

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

  10. Standardized Cosmesis and Health Nasal Outcomes Survey - Obstruction

    Time frame: Preoperative baseline and one month postoperatively

    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.

  11. Standardized Cosmesis and Health Nasal Outcomes Survey - Cosmesis

    Time frame: Preoperative baseline and one month postoperatively

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew Wu, MD

CONTACT

[email protected]

314-362-0524

Sara Kukuljan, BS, RN

CONTACT

[email protected]

314-362-7563

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 8, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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