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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal Bupivacaine | Experimental | Participants randomized to the experimental arm will receive bilateral supraorbital and infraorbital nerve blocks using liposomal bupivacaine at the end of surgery. |
|
| Standard Bupivacaine | Active Comparator | The control arm will receive standard bupivacaine nerve blocks using the same injection sites and volumes appropriate for safe regional anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Bupivacaine | Drug | Volume: 4 mL of 0.75% bupivacaine hydrochloride |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative opioid consumption | Cumulative opioid consumption in the first 72 post-operative hours expressed in morphine milligram equivalents (MME). | First 72 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew Wu, MD | Contact | 314-362-0524 | mjwu@wustl.edu | |
| Sara Kukuljan, BS, RN | Contact | 314-362-7563 | kukuljas@wustl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Matthew Wu, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32031696 | Background | 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. | |
| 30843623 | Background | 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. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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This study is a single-site, prospective, randomized, single-blinded clinical trial
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single-blinded
| Liposomal Bupivacaine | Drug | Volume: 1.5 mL of 0.75% bupivacaine hydrochloride and 2.5 mL of liposomal bupivacaine |
|
|
| Postoperative day 0 through postoperative day 7 |
| 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). | Postoperative day 0 through postoperative day 7 |
| 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. | Postoperative day 0 through postoperative day 7 |
| Vomiting | Incidence of vomiting, an opioid-related symptom assessed via daily postoperative patient self-report surveys. | Postoperative day 0 through postoperative day 7 |
| Constipation | Incidence of constipation, an opioid-related symptom assessed via daily postoperative patient self-report surveys. | Postoperative day 0 through postoperative day 7 |
| Rash | 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 | 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 | 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 | 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 | 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. | Preoperative baseline and one month postoperatively |
| 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. | Preoperative baseline and one month postoperatively |
| 26204387 | Background | 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. |
| 37775576 | Background | 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. |
| 10640654 | Background | 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. |
| 22013534 | Background | 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. |
| 24612918 | Background | 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. |
| 27281722 | Background | 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. |
| 34293514 | Background | 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. |
| 33464760 | Background | 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. |
| Background | 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 |
| 22900785 | Background | 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. |
| Background | FDA. EXPAREL- bupivacaine injection, suspension, liposomal. FDA2024 |
| Background | FDA. MARCAINE - bupivacaine hydrochloride injection, solution. 2012. |
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| 17585363 | Background | 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. |
| 27355574 | Background | Shin KJ, Shin HJ, Lee SH, Song WC, Koh KS, Gil YC. Emerging Points of the Supraorbital and Supratrochlear Nerves in the Supraorbital Margin With Reference to the Lacrimal Caruncle: Implications for Regional Nerve Block in Upper Eyelid and Dermatologic Surgery. Dermatol Surg. 2016 Aug;42(8):992-8. doi: 10.1097/DSS.0000000000000818. |
| 33372949 | Background | 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. |
| 32739962 | Background | Nedeljkovic SS, Kett A, Vallejo MC, Horn JL, Carvalho B, Bao X, Cole NM, Renfro L, Gadsden JC, Song J, Yang J, Habib AS. Transversus Abdominis Plane Block With Liposomal Bupivacaine for Pain After Cesarean Delivery in a Multicenter, Randomized, Double-Blind, Controlled Trial. Anesth Analg. 2020 Dec;131(6):1830-1839. doi: 10.1213/ANE.0000000000005075. |
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| 28727583 | Background | Buys MJ, Murphy MF, Warrick CM, Pace NL, Gililland JM, Pelt CE, Bankhead BR, Patzkowsky JL, Johnson KB. Serum Bupivacaine Concentration After Periarticular Injection With a Mixture of Liposomal Bupivacaine and Bupivacaine HCl During Total Knee Arthroplasty. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):582-587. doi: 10.1097/AAP.0000000000000636. |
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| 30821824 | Background | Hah JM, Cramer E, Hilmoe H, Schmidt P, McCue R, Trafton J, Clay D, Sharifzadeh Y, Ruchelli G, Goodman S, Huddleston J, Maloney WJ, Dirbas FM, Shrager J, Costouros JG, Curtin C, Mackey SC, Carroll I. Factors Associated With Acute Pain Estimation, Postoperative Pain Resolution, Opioid Cessation, and Recovery: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2019 Mar 1;2(3):e190168. doi: 10.1001/jamanetworkopen.2019.0168. |
| 28880988 | Background | 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. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |