Liposomal Bupivacaine vs Standard Bupivacaine for Post-Rhinoplasty Analgesia
2026년 8월 17일 업데이트: Washington University School of Medicine
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.
연구 개요
상태
상태
모병
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
45
단계
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Matthew Wu, MD
- 전화번호: 314-362-0524
- 이메일: mjwu@wustl.edu
연구 연락처 백업
- 이름: Sara Kukuljan, BS, RN
- 전화번호: 314-362-7563
- 이메일: kukuljas@wustl.edu
연구 장소
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Missouri
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St Louis, Missouri, 미국, 63110
- 모병
- Washington University
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연락하다:
- Sara Kukuljan, BS, RN
- 전화번호: 314-362-7563
- 이메일: kukuljas@wustl.edu
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: Liposomal Bupivacaine
Participants randomized to the experimental arm will receive bilateral supraorbital and infraorbital nerve blocks using liposomal bupivacaine at the end of surgery.
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Volume: 1.5 mL of 0.75% bupivacaine hydrochloride and 2.5 mL of liposomal bupivacaine
다른 이름들:
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활성 비교기: Standard Bupivacaine
The control arm will receive standard bupivacaine nerve blocks using the same injection sites and volumes appropriate for safe regional anesthesia
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Volume: 4 mL of 0.75% bupivacaine hydrochloride
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cumulative opioid consumption
기간: First 72 hours postoperatively
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Cumulative opioid consumption in the first 72 post-operative hours expressed in morphine milligram equivalents (MME).
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First 72 hours postoperatively
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Vomiting
기간: Postoperative day 0 through postoperative day 7
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Incidence of vomiting, an opioid-related symptom assessed via daily postoperative patient self-report surveys.
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Postoperative day 0 through postoperative day 7
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Constipation
기간: Postoperative day 0 through postoperative day 7
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Incidence of constipation, an opioid-related symptom assessed via daily postoperative patient self-report surveys.
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Postoperative day 0 through postoperative day 7
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Rash
기간: Postoperative day 0 through postoperative day 7
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Incidence of rash, an opioid-related symptom assessed via daily postoperative patient self-report surveys.
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Postoperative day 0 through postoperative day 7
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Adherence to ERAS Multimodal Analgesic Regimen
기간: Postoperative day 0 through postoperative day 7
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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%.
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Postoperative day 0 through postoperative day 7
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Block site safety
기간: Preoperative baseline and one month postoperatively
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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.
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Preoperative baseline and one month postoperatively
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Adverse Events
기간: Postoperative day 0 through one month postoperatively
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Capturing any adverse events classified according to prespecified criteria described in the protocol.
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Postoperative day 0 through one month postoperatively
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Modified Brief Pain Inventory - Pain Outcomes
기간: Postoperative day 0 through postoperative day 7
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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.
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Postoperative day 0 through postoperative day 7
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Modified Brief Pain Inventory - Pain relief from analgesic medication
기간: Postoperative day 0 through postoperative day 7
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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).
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Postoperative day 0 through postoperative day 7
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Nausea
기간: Postoperative day 0 through postoperative day 7
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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.
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Postoperative day 0 through postoperative day 7
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Standardized Cosmesis and Health Nasal Outcomes Survey - Obstruction
기간: Preoperative baseline and one month postoperatively
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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.
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Preoperative baseline and one month postoperatively
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Standardized Cosmesis and Health Nasal Outcomes Survey - Cosmesis
기간: Preoperative baseline and one month postoperatively
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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.
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Preoperative baseline and one month postoperatively
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 수석 연구원: Matthew Wu, MD, Washington University School of Medicine
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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- Ilfeld BM, Eisenach JC, Gabriel RA. Clinical Effectiveness of Liposomal Bupivacaine Administered by Infiltration or Peripheral Nerve Block to Treat Postoperative Pain. Anesthesiology. 2021 Feb 1;134(2):283-344. doi: 10.1097/ALN.0000000000003630.
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- 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.
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- 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.
- 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.
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- Moubayed SP, Ioannidis JPA, Saltychev M, Most SP. The 10-Item Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) for Functional and Cosmetic Rhinoplasty. JAMA Facial Plast Surg. 2018 Jan 1;20(1):37-42. doi: 10.1001/jamafacial.2017.1083.
- 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.
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- 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.
- 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.
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- Hu KS, Kwak J, Koh KS, Abe S, Fontaine C, Kim HJ. Topographic distribution area of the infraorbital nerve. Surg Radiol Anat. 2007 Jul;29(5):383-8. doi: 10.1007/s00276-007-0227-z. Epub 2007 Jun 22.
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2026년 8월 1일
기본 완료 (추정된)
기본 완료
2027년 6월 1일
연구 완료 (추정된)
연구 완료
2027년 7월 1일
연구 등록 날짜
최초 제출
최초 제출
2026년 6월 30일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 6월 30일
처음 게시됨 (실제)
처음 게시됨
2026년 7월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 8월 18일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 17일
마지막으로 확인됨
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 202601024
개별 참가자 데이터(IPD) 계획
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아니요
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예
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아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .