Multimodal Pain Management After Wide Awake Local Anesthesia No Tourniquet Orthopedic Hand Surgery: A Randomized Control Trial

Обзор

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). 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.

Подробное описание

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.

Вмешательства

• Препарат Oxycodone 5mg taken first
  10 pills of 5mg oxycodone Q4hrs as needed
• Препарат Acetaminophen
  30 pills of 500mg acetaminophen Q4hrs
• Препарат Naproxen Tablets, 500 mg
  30 pills of 500mg naproxen Q4hrs
• Препарат OxyCODONE 5 mg Oral Tablet
  Only used for breakthrough pain

Первичные конечные точки

• VAS Pain Scores [Срок оценки: From enrollment to the end of treatment at 7 days]
• Patient Satisfaction [Срок оценки: From enrollment to the end of treatment at 7 days]
• Total Opioid Usage [Срок оценки: From enrollment to the end of treatment at 7 days]

Вторичные конечные точки (3)

• Breakthrough Pain [Срок оценки: From enrollment to the end of treatment at 7 days]
• Length of Treatment [Срок оценки: From enrollment to the end of treatment at 7 days]
• Indication for WALANT surgery [Срок оценки: From enrollment to the end of treatment at 7 days]

Критерии участия

Критерии включения

• Patients 21-70 years of age undergoing outpatient hand surgery
• Patients undergoing surgery with WALANT technique
• Patients who provide written informed consent

Критерии исключения

• Patients aged 20 and younger, or 71 and older
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Пуэрто-Рико · 1 центр

• Oncological Hospital — San Juan

Публикации

• 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 32983779
• 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 31690136
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• 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 20697319
• 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 38260757
• 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 33732855
• 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 Art PMID 32571591
• 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 31311667

Идентификаторы

NCT: NCT06917118 · 2501339638

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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