Wrist Reduction Intervention: Supracondylar Technique for Radial Nerve Block vs. Hematoma Block (WRIST Block Study)

Обзор

The purpose of this study is to compare different types of local anesthesia-a supracondylar radial nerve block, a hematoma block, or a combination of the two-for reducing pain in people with a broken wrist (distal radius fracture). This is being done to find out which method provides better pain relief after the injury and during treatment in the emergency room.

Подробное описание

This study is testing different ways to provide pain relief before reducing a broken wrist. Participants will receive one of three techniques: (1) a nerve block where a doctor injects lidocaine near the radial nerve under ultrasound guidance; (2) a hematoma block where a doctor injects lidocaine into the area where the bone broke; or (3) both the nerve block and the hematoma block. Patients will be asked how much pain they feel before the numbing, after the numbing, and after the wrist is reduced.

Вмешательства

• Процедура Supracondylar radial nerve block
  Supracondylar radial nerve blocks given at the radial nerve not as the same location of the fracture site, prior to fracture reduction.
• Процедура Hematoma block
  Injection of analgesia into the hematoma that forms surrounding the wrist fracture.
• Процедура Combination of blocks
  Supracondylar radial nerve block given first, followed by hematoma block, before fracture reduction.

Первичные конечные точки

• Pain levels comparison [Срок оценки: Pain will be measured at (1) baseline, (2) after administering the assigned pain block(s), and after the (3) fracture reduction.]

Вторичные конечные точки (3)

• Amount of opioid medication needed to control pain. [Срок оценки: Opioid medication prescribing will be assessed at baseline, time of admission to the emergency room, until the patient is discharged and they are no longer active in the study.]
• Number of patients requiring conscious sedation. [Срок оценки: Patients will be monitored for need of conscious sedation from baseline, time of enrollment in the study, until discharge from the emergency room, when they are no longer active in the study.]
• Adverse Events Monitoring [Срок оценки: From baseline, time the patient is admitted and enrolled into the study, until the patient is discharged and no longer active in the study.]

Критерии участия

Критерии включения

• 18 years of age or older
• Patients admitted to the ECC with a distal radius fracture requiring closed reduction
• Patient must be willing and able to provide informed consent to the study

Критерии исключения

• Under 18 years of age
• Pregnant
• Prisoner
• Allergy to lidocaine
• Patients unable to provide informed consent and/or perform study-related activities
• Patients undergoing procedural sedation
• Patients may be excluded at the discretion of the investigator based on their clinical judgment, if the participant no longer meets criteria, and/or if the health or safety of the patient may be impacted by taking part in the study.

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

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Sarasota Memorial Health Care System — Sarasota

Публикации

• Tseng PT, Leu TH, Chen YW, Chen YP. Hematoma block or procedural sedation and analgesia, which is the most effective method of anesthesia in reduction of displaced distal radius fracture? J Orthop Surg Res. 2018 Mar 27;13(1):62. doi: 10.1186/s13018-018-0772-7. PMID 29580286
• Siebelt M, Hartholt KA, van Winden DFM, Boot F, Papathanasiou D, Verdouw BC, de Vries MR, Mathijssen NM, Kraan GA. Ultrasound-Guided Nerve Blocks as Analgesia for Nonoperative Management of Distal Radius Fractures-Two Consecutive Randomized Controlled Trials. J Orthop Trauma. 2019 Apr;33(4):e124-e130. doi: 10.1097/BOT.0000000000001388. PMID 30893220
• Oakley B, Busby C, Kulkarni S, Arnold SJ, Kulkarni SS, Ollivere BJ. Manipulation of distal radius fractures: a comparison of Bier's block vs haematoma block. Ann R Coll Surg Engl. 2023 May;105(5):434-440. doi: 10.1308/rcsann.2022.0116. Epub 2022 Oct 14. PMID 36239973
• Maia GAS, Cunha JC, Feijo CQ, Leal DM, Moreira JJ, Herrero CFPDS. Radial Nerve Supracondylar Block Versus Fracture Hematoma Block. Comparison of Their Efficacy in Cases of Fractures of the Distal Third of the Radius. Rev Bras Ortop (Sao Paulo). 2023 Aug 30;58(4):e557-e562. doi: 10.1055/s-0043-1768623. eCollection 2023 Aug. PMID 37663190
• Handoll HH, Madhok R, Dodds C. Anaesthesia for treating distal radial fracture in adults. Cochrane Database Syst Rev. 2002;2002(3):CD003320. doi: 10.1002/14651858.CD003320. PMID 12137688
• Haley CB, Beauchesne AR, Fox JC, Nelson AM. Block Time: A Multispecialty Systematic Review of Efficacy and Safety of Ultrasound-guided Upper Extremity Nerve Blocks. West J Emerg Med. 2023 Jun 30;24(4):774-785. doi: 10.5811/westjem.56058. PMID 37527380
• Gottlieb M, Cosby K. Ultrasound-guided hematoma block for distal radial and ulnar fractures. J Emerg Med. 2015 Mar;48(3):310-2. doi: 10.1016/j.jemermed.2014.09.063. Epub 2014 Dec 9. PMID 25497895
• Martinez-Arboleda JJ, Moreno M, Diaz-Solorzano JP, Mejia-Grueso A. Ultrasound-guided supracondylar radial nerve block for closed reduction of a distal radius fracture in the emergency department: Case report. Trauma Case Rep. 2024 Sep 25;54:101116. doi: 10.1016/j.tcr.2024.101116. eCollection 2024 Dec. PMID 39399762

Идентификаторы

NCT: NCT07268547 · 25-MEDI-58

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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