Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT06917118
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-08
First Post:
2025-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multimodal Pain Management After Wide Awake Local Anesthesia No Tourniquet Orthopedic Hand Surgery: A Randomized Control Trial
Sponsor:
Organization:
Raw JSON
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Patients will take the questionnaire home and report pain scores in the morning and in the afternoon every day for a week.'}, {'measure': 'Patient Satisfaction', 'timeFrame': 'From enrollment to the end of treatment at 7 days', 'description': 'Patient satisfaction will be assessed using the Patient Satisfaction Questionnaire Short Form (PSQ-18)'}, {'measure': 'Total Opioid Usage', 'timeFrame': 'From enrollment to the end of treatment at 7 days', 'description': 'Will be reported in as morphine milligram equivalents (MMEs)'}], 'secondaryOutcomes': [{'measure': 'Breakthrough Pain', 'timeFrame': 'From enrollment to the end of treatment at 7 days', 'description': 'Breakthrough pain will be reported as a binary outcome (Y/N)'}, {'measure': 'Length of Treatment', 'timeFrame': 'From enrollment to the end of treatment at 7 days', 'description': 'Patients will be asked to report the number of days in which they used the provided pain control treatment'}, {'measure': 'Indication for WALANT surgery', 'timeFrame': 'From enrollment to the end of treatment at 7 days', 'description': 'We will report the indication for treatment for each patient to include in the final analysis'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['WALANT', 'Multimodal analgesia', 'Nonopioid pain management', 'VAS pain scores'], 'conditions': ['Pain Management']}, 'referencesModule': {'references': [{'pmid': '32983779', 'type': 'BACKGROUND', 'citation': 'Abdullah S, Ahmad AA, Lalonde D. Wide Awake Local Anesthesia No Tourniquet Forearm Triple Tendon Transfer in Radial Nerve Palsy. Plast Reconstr Surg Glob Open. 2020 Aug 11;8(8):e3023. doi: 10.1097/GOX.0000000000003023. eCollection 2020 Aug.'}, {'pmid': '31690136', 'type': 'BACKGROUND', 'citation': 'Burn MB, Shapiro LM, Eppler SL, Behal R, Kamal RN. Clinical Care Redesign to Improve Value for Trigger Finger Release: A Before-and-After Quality Improvement Study. Hand (N Y). 2021 Sep;16(5):624-631. doi: 10.1177/1558944719884661. Epub 2019 Nov 5.'}, {'pmid': '16182068', 'type': 'BACKGROUND', 'citation': 'Lalonde D, Bell M, Benoit P, Sparkes G, Denkler K, Chang P. A multicenter prospective study of 3,110 consecutive cases of elective epinephrine use in the fingers and hand: the Dalhousie Project clinical phase. J Hand Surg Am. 2005 Sep;30(5):1061-7. doi: 10.1016/j.jhsa.2005.05.006.'}, {'pmid': '20697319', 'type': 'BACKGROUND', 'citation': 'Chowdhry S, Seidenstricker L, Cooney DS, Hazani R, Wilhelmi BJ. Do not use epinephrine in digital blocks: myth or truth? Part II. A retrospective review of 1111 cases. Plast Reconstr Surg. 2010 Dec;126(6):2031-2034. doi: 10.1097/PRS.0b013e3181f44486.'}, {'pmid': '38260757', 'type': 'BACKGROUND', 'citation': 'Sawhney A, Thacoor A, Nagra R, Geoghegan L, Akhavani M. Wide Awake Local Anesthetic No Tourniquet in Hand and Wrist Surgery: Current Concepts, Indications, and Considerations. Plast Reconstr Surg Glob Open. 2024 Jan 22;12(1):e5526. doi: 10.1097/GOX.0000000000005526. eCollection 2024 Jan.'}, {'pmid': '33732855', 'type': 'BACKGROUND', 'citation': 'Deutsch CJ, Jones K, Dassayanake S, Milroy C. Concern about ischaemia drives a persistent and generation-spanning aversion to adrenaline in digital anaesthesia. JPRAS Open. 2021 Jan 26;28:61-63. doi: 10.1016/j.jpra.2021.01.006. eCollection 2021 Jun. No abstract available.'}, {'pmid': '32571591', 'type': 'BACKGROUND', 'citation': 'Fillingham YA, Hannon CP, Erens GA; AAHKS Anesthesia & Analgesia Clinical Practice Guideline Workgroup; Hamilton WG, Della Valle CJ. Acetaminophen in Total Joint Arthroplasty: The Clinical Practice Guidelines of the American Association of Hip and Knee Surgeons, American Society of Regional Anesthesia and Pain Medicine, American Academy of Orthopaedic Surgeons, Hip Society, and Knee Society. J Arthroplasty. 2020 Oct;35(10):2697-2699. doi: 10.1016/j.arth.2020.05.030. Epub 2020 May 26. No abstract available.'}, {'pmid': '31311667', 'type': 'BACKGROUND', 'citation': 'Padilla JA, Gabor JA, Schwarzkopf R, Davidovitch RI. A Novel Opioid-Sparing Pain Management Protocol Following Total Hip Arthroplasty: Effects on Opioid Consumption, Pain Severity, and Patient-Reported Outcomes. J Arthroplasty. 2019 Nov;34(11):2669-2675. doi: 10.1016/j.arth.2019.06.038. Epub 2019 Jun 26.'}, {'pmid': '11293556', 'type': 'BACKGROUND', 'citation': 'Gimbel JS, Brugger A, Zhao W, Verburg KM, Geis GS. Efficacy and tolerability of celecoxib versus hydrocodone/acetaminophen in the treatment of pain after ambulatory orthopedic surgery in adults. Clin Ther. 2001 Feb;23(2):228-41. doi: 10.1016/s0149-2918(01)80005-9.'}, {'pmid': '33615243', 'type': 'BACKGROUND', 'citation': 'Thompson KA, Klein D, Alaia MJ, Strauss EJ, Jazrawi LM, Campbell KA. Opioid Use Is Reduced in Patients Treated with NSAIDs After Arthroscopic Bankart Repair: A Randomized Controlled Study. Arthrosc Sports Med Rehabil. 2020 Dec 27;3(1):e15-e22. doi: 10.1016/j.asmr.2020.08.003. eCollection 2021 Feb.'}, {'pmid': '38579315', 'type': 'BACKGROUND', 'citation': 'Hess-Arcelay H, Claudio-Marcano A, Torres-Lugo NJ, Deliz-Jimenez D, Acosta-Julbe J, Hernandez G, Deliz-Jimenez D, Monge G, Ramirez N, Lojo-Sojo L. Opioid-Sparing Nonsteroid Anti-inflammatory Drugs Protocol in Patients Undergoing Intramedullary Nailing of Tibial Shaft Fractures: A Randomized Control Trial. J Am Acad Orthop Surg. 2024 Jun 15;32(12):e596-e604. doi: 10.5435/JAAOS-D-23-01014. Epub 2024 Apr 4.'}, {'pmid': '22227789', 'type': 'BACKGROUND', 'citation': 'American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.'}, {'pmid': '9322460', 'type': 'BACKGROUND', 'citation': 'Chung F, Ritchie E, Su J. Postoperative pain in ambulatory surgery. Anesth Analg. 1997 Oct;85(4):808-16. doi: 10.1097/00000539-199710000-00017.'}, {'pmid': '17543801', 'type': 'BACKGROUND', 'citation': 'Pasero C, McCaffery M. Orthopaedic postoperative pain management. J Perianesth Nurs. 2007 Jun;22(3):160-72; quiz 172-3. doi: 10.1016/j.jopan.2007.02.004.'}, {'pmid': '30075877', 'type': 'BACKGROUND', 'citation': 'Trasolini NA, McKnight BM, Dorr LD. The Opioid Crisis and the Orthopedic Surgeon. J Arthroplasty. 2018 Nov;33(11):3379-3382.e1. doi: 10.1016/j.arth.2018.07.002. Epub 2018 Jul 11.'}, {'pmid': '18418226', 'type': 'BACKGROUND', 'citation': 'Harris JD. Management of expected and unexpected opioid-related side effects. Clin J Pain. 2008 May;24 Suppl 10:S8-S13. doi: 10.1097/AJP.0b013e31816b58eb.'}, {'pmid': '36960481', 'type': 'BACKGROUND', 'citation': 'Huynh MNQ, Yuan M, Gallo L, Olaiya OR, Barkho J, McRae M. Opioid Consumption After Upper Extremity Surgery: A Systematic Review. Hand (N Y). 2024 Sep;19(6):1002-1011. doi: 10.1177/15589447231160211. Epub 2023 Mar 23.'}, {'pmid': '29215370', 'type': 'BACKGROUND', 'citation': 'Feinberg AE, Chesney TR, Srikandarajah S, Acuna SA, McLeod RS; Best Practice in Surgery Group. Opioid Use After Discharge in Postoperative Patients: A Systematic Review. Ann Surg. 2018 Jun;267(6):1056-1062. doi: 10.1097/SLA.0000000000002591.'}, {'pmid': '30270011', 'type': 'BACKGROUND', 'citation': 'Fader L, Whitaker J, Lopez M, Vivace B, Parra M, Carlson J, Zamora R. Tibia fractures and NSAIDs. Does it make a difference? A multicenter retrospective study. Injury. 2018 Dec;49(12):2290-2294. doi: 10.1016/j.injury.2018.09.024. Epub 2018 Sep 18.'}, {'pmid': '22410178', 'type': 'BACKGROUND', 'citation': 'Rodgers J, Cunningham K, Fitzgerald K, Finnerty E. Opioid consumption following outpatient upper extremity surgery. J Hand Surg Am. 2012 Apr;37(4):645-50. doi: 10.1016/j.jhsa.2012.01.035. Epub 2012 Mar 10.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of the study is to measure the efficacy of a multimodal postoperative pain regimen consisting of oral acetaminophen and naproxen compared to a traditional opioid-only pain regimen following elective wide awake local anesthesia no tourniquet (WALANT) hand surgery in a Hispanic population. The study is a randomized control trial comparing the clinical outcomes of patients undergoing elective WALANT hand surgery performed by a board-certified, fellowship-trained orthopedic hand surgeon (Dr. Christian A. Foy).\n\nThe study groups are:\n\n* Control group: standard pain control with opioids\n* Experimental group: multimodal non-opioid pain control\n\nStudy Outcomes are:\n\n* VAS pain scores (7 days),\n* Total opioid usage\n* Patient satisfaction\n* Adverse events\n\nWe hypothesize that patients receiving multimodal pain regimens will report lower opioid use, lower pain scores, and greater satisfaction than patients receiving traditional opioid-only pain management.', 'detailedDescription': 'The main objective of the study is to measure the efficacy of a multimodal postoperative pain regimen consisting of oral acetaminophen and naproxen compared to a traditional opioid-only pain regimen following elective wide awake local anesthesia no tourniquet (WALANT) hand surgery in a Hispanic population. The study is a single-blind, single-center randomized control trial comparing the clinical outcomes of patients undergoing elective WALANT hand surgery performed by a board-certified, fellowship-trained orthopedic hand surgeon (Dr. Christian A. Foy). Patients will be consecutively recruited at the center and randomized in a 1:1 ratio into the control and experimental groups. The control group will receive the standard of care for postoperative pain: 10 pills of 5mg oxycodone Q4hrs as needed. The experimental group will receive 30 pills of 500mg acetaminophen Q4hrs and 30 pills of 500mg naproxen Q4hrs until pain resolves or treatment is completed. The experimental group will also receive 5 tablets of 5mg oxycodone to take Q4hrs as needed for breakthrough pain. Postoperatively, daily pain Visual Analog Scale (VAS) scores, total opioid usage, patient satisfaction, and adverse events will be recorded. We hypothesize that patients receiving multimodal pain regimens will report lower opioid use, lower pain scores, and greater satisfaction than patients receiving traditional opioid-only pain management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 21-70 years of age undergoing outpatient hand surgery\n* Patients undergoing surgery with WALANT technique\n* Patients who provide written informed consent\n\nExclusion Criteria:\n\n* Patients aged 20 and younger, or 71 and older\n* Patient with chronic pain requiring opioid use\n* Pregnant patients\n* Patients who do not self-identify as Hispanic\n* Patients with known allergy to the medication\n* Patients with contraindications for the prescribed medications'}, 'identificationModule': {'nctId': 'NCT06917118', 'acronym': 'WALANT', 'briefTitle': 'Multimodal Pain Management After Wide Awake Local Anesthesia No Tourniquet Orthopedic Hand Surgery: A Randomized Control Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Puerto Rico'}, 'officialTitle': 'Multimodal Pain Management After Wide Awake Local Anesthesia No Tourniquet Orthopedic Hand Surgery: A Randomized Control Trial', 'orgStudyIdInfo': {'id': '2501339638'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Postoperative opioid analgesia', 'description': '10 pills of 5mg oxycodone Q4hrs as needed', 'interventionNames': ['Drug: Oxycodone 5mg taken first']}, {'type': 'EXPERIMENTAL', 'label': 'Postoperative Opioid-sparing Multimodal analgesia', 'description': '30 pills of 500mg acetaminophen Q4hrs and 30 pills of 500mg naproxen Q4hrs. Will also receive 5 tablets of 5mg oxycodone to take Q4hrs as needed for breakthrough pain', 'interventionNames': ['Drug: Acetaminophen', 'Drug: Naproxen Tablets, 500 mg', 'Drug: OxyCODONE 5 mg Oral Tablet']}], 'interventions': [{'name': 'Oxycodone 5mg taken first', 'type': 'DRUG', 'description': '10 pills of 5mg oxycodone Q4hrs as needed', 'armGroupLabels': ['Standard Postoperative opioid analgesia']}, {'name': 'Acetaminophen', 'type': 'DRUG', 'description': '30 pills of 500mg acetaminophen Q4hrs', 'armGroupLabels': ['Postoperative Opioid-sparing Multimodal analgesia']}, {'name': 'Naproxen Tablets, 500 mg', 'type': 'DRUG', 'description': '30 pills of 500mg naproxen Q4hrs', 'armGroupLabels': ['Postoperative Opioid-sparing Multimodal analgesia']}, {'name': 'OxyCODONE 5 mg Oral Tablet', 'type': 'DRUG', 'description': 'Only used for breakthrough pain', 'armGroupLabels': ['Postoperative Opioid-sparing Multimodal analgesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00935', 'city': 'San Juan', 'state': 'PR', 'country': 'Puerto Rico', 'contacts': [{'name': 'Jose I Acosta Julbe, MD', 'role': 'CONTACT', 'email': 'jose.acosta14@upr.edu', 'phone': '+1 7873794119'}], 'facility': 'Oncological Hospital', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'centralContacts': [{'name': 'Jose I Acosta Julbe, MD', 'role': 'CONTACT', 'email': 'jose.acosta14@upr.edu', 'phone': '+1 7873794119'}, {'name': 'Daniel E. Deliz Jiménez, BSc', 'role': 'CONTACT', 'email': 'daniel.deliz@upr.edu', 'phone': '+1 7872332369'}], 'overallOfficials': [{'name': 'Christian A. Foy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Puerto Rico Medical Sciences Campus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual Participant Data (IPD) will only be used internally by the study PI and primary investigators.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Puerto Rico', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Christian A. Foy', 'investigatorFullName': 'Daniel Deliz', 'investigatorAffiliation': 'University of Puerto Rico'}}}}