Multimodal Pain Management After Wide Awake Local Anesthesia No Tourniquet Orthopedic Hand Surgery: A Randomized Control Trial
NCT ID: NCT06917118
Last Updated: 2025-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2025-05-01
2025-12-01
Brief Summary
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The study groups are:
* Control group: standard pain control with opioids
* Experimental group: multimodal non-opioid pain control
Study Outcomes are:
* VAS pain scores (7 days),
* Total opioid usage
* Patient satisfaction
* Adverse events
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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Standard Postoperative opioid analgesia
10 pills of 5mg oxycodone Q4hrs as needed
Oxycodone 5mg taken first
10 pills of 5mg oxycodone Q4hrs as needed
Postoperative Opioid-sparing Multimodal analgesia
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
Acetaminophen
30 pills of 500mg acetaminophen Q4hrs
Naproxen Tablets, 500 mg
30 pills of 500mg naproxen Q4hrs
OxyCODONE 5 mg Oral Tablet
Only used for breakthrough pain
Interventions
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Oxycodone 5mg taken first
10 pills of 5mg oxycodone Q4hrs as needed
Acetaminophen
30 pills of 500mg acetaminophen Q4hrs
Naproxen Tablets, 500 mg
30 pills of 500mg naproxen Q4hrs
OxyCODONE 5 mg Oral Tablet
Only used for breakthrough pain
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing surgery with WALANT technique
* Patients who provide written informed consent
Exclusion Criteria
* Patient with chronic pain requiring opioid use
* Pregnant patients
* Patients who do not self-identify as Hispanic
* Patients with known allergy to the medication
* Patients with contraindications for the prescribed medications
21 Years
70 Years
ALL
No
Sponsors
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University of Puerto Rico
OTHER
Responsible Party
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Daniel Deliz
Dr. Christian A. Foy
Principal Investigators
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Christian A. Foy, MD
Role: PRINCIPAL_INVESTIGATOR
University of Puerto Rico Medical Sciences Campus
Locations
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Oncological Hospital
San Juan, PR, Puerto Rico
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2501339638
Identifier Type: -
Identifier Source: org_study_id
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