Supra Inguinal Fascia Iliaca Block as Rescue Analgesia Following Total Hip Arthroplasty

Обзор

Hip replacement surgery is one of the most commonly performed surgical procedures in France, with approximately 150,000 procedures per year. Postoperative recovery has significantly improved in recent years, enabling faster rehabilitation. Although generally considered moderately painful, hip replacement surgery can, in some difficult-to-predict cases, lead to severe postoperative pain, requiring high doses of morphine, which may cause side effects and delay recovery. In other surgical procedures, regional anesthesia (nerve blocks) has been successfully used for pain relief. However, its effectiveness after hip replacement surgery has not yet been fully proven. A recent regional anesthesia technique-the Supra-Inguinal Fascia Iliaca Block (SIFIB)-which numbs a significant portion of the nerves around the hip, has recently been developed. When performed in all patients undergoing hip arthroplasty, the benefit of this technique could not be demonstrated. In addition, this technique may lead to transcient muscle blockade, wich also can delay recovery. In order to limit the use of nerve blocks to painful patients, we designed this study where the nerve block is performed only in patients experiencing significant paint after surgery. In conclusion, this study aims to assess the benefits of performing a rescue SIFIB in the recovery room for patients who experience significant postoperative pain after hip replacement surgery. The evaluation will focus on pain relief and ability to walk. No new treatment is being tested. The technique uses a commonly administered local anesthetic to numb the nerves.

Вмешательства

• Процедура Ultrasound guided supra inguinal fascia iliaca block
  The ultrasound probe is placed in a cephalo-caudal orientation, over the inguinal ligament, lateral to the femoral nerve. The iliacus muscle, which is covered caudally by the sartorius muscle and cephalically by the internal oblique muscle, is visualized in depth. Between these two muscles, an area is identified where the iliacus muscle is covered only by subcutaneous tissue. The needle is introduced in a cranio-caudal direction, and the injection is initiated in this area, beneath the fascia il
• Процедура Placebo Injection
  Five milliliters of saline are injected subcutaneously under ultrasound guidance
• Процедура Surgical and anesthetic protocol
  All patients receive standard general anesthesia: * Induction of anesthesia by sufentanil, ketamine, propofol and tracrium if needed, * Maintenance of anesthesia by sevoflurane and sufentanil if needed, * Prevention of PONV by dexamethasone and droperidol, * Post-operative analgesia by paracetamol, ketoprofene, nefopam, as indicated. Total hip arthroplasty is performed by anterior or postero-lateral approach, depending on surgeon preference. In the post-anesthesia care unit, if numerical pain

Первичные конечные точки

• Composite outcome [Срок оценки: 2 hours post operatively]

Вторичные конечные точки (4)

• Morphine consumption [Срок оценки: 24 hours post operatively]
• Pain evaluation [Срок оценки: 6, 12 and 24 hours post operatively]
• Length of hospital stay [Срок оценки: An average of 2 to 3 days up to 1 week]
• Patient satisfaction [Срок оценки: Day 1]

Критерии участия

Критерии включения

• patient scheduled for a primary total hip arthroplasty under general anesthesia,
• written informed consent.

Non inclusion criteria:

• contra indication to ropivacaine
• vulnerable person

Критерии исключения

• per-operative complication making wheight-bearing and walking contra-indicated.
• patient without significant pain post-operatively.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Institut Mutualiste Montsouris — Paris

Публикации

• Desmet M, Vermeylen K, Van Herreweghe I, Carlier L, Soetens F, Lambrecht S, Croes K, Pottel H, Van de Velde M. A Longitudinal Supra-Inguinal Fascia Iliaca Compartment Block Reduces Morphine Consumption After Total Hip Arthroplasty. Reg Anesth Pain Med. 2017 May/Jun;42(3):327-333. doi: 10.1097/AAP.0000000000000543. PMID 28059869
• Zhang XY, Ma JB. The efficacy of fascia iliaca compartment block for pain control after total hip arthroplasty: a meta-analysis. J Orthop Surg Res. 2019 Jan 25;14(1):33. doi: 10.1186/s13018-018-1053-1. PMID 30683117
• Changjun C, Xin Z, Yue L, Liyile C, Pengde K. Key Elements of Enhanced Recovery after Total Joint Arthroplasty: A Reanalysis of the Enhanced Recovery after Surgery Guidelines. Orthop Surg. 2023 Mar;15(3):671-678. doi: 10.1111/os.13623. Epub 2023 Jan 3. PMID 36597677
• Bloc S, Alfonsi P, Belbachir A, Beaussier M, Bouvet L, Campard S, Campion S, Cazenave L, Diemunsch P, Di Maria S, Dufour G, Fabri S, Fletcher D, Garnier M, Godier A, Grillo P, Huet O, Joosten A, Lasocki S, Le Guen M, Le Sache F, Macquer I, Marquis C, de Montblanc J, Maurice-Szamburski A, Nguyen YL, Ruscio L, Zieleskiewicz L, Caillard A, Weiss E. Guidelines on perioperative optimization protocol fo PMID 37295649
• Anger M, Valovska T, Beloeil H, Lirk P, Joshi GP, Van de Velde M, Raeder J; PROSPECT Working Group* and the European Society of Regional Anaesthesia and Pain Therapy. PROSPECT guideline for total hip arthroplasty: a systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2021 Aug;76(8):1082-1097. doi: 10.1111/anae.15498. Epub 2021 May 20. PMID 34015859
• Memtsoudis SG, Cozowicz C, Bekeris J, Bekere D, Liu J, Soffin EM, Mariano ER, Johnson RL, Go G, Hargett MJ, Lee BH, Wendel P, Brouillette M, Kim SJ, Baaklini L, Wetmore DS, Hong G, Goto R, Jivanelli B, Athanassoglou V, Argyra E, Barrington MJ, Borgeat A, De Andres J, El-Boghdadly K, Elkassabany NM, Gautier P, Gerner P, Gonzalez Della Valle A, Goytizolo E, Guo Z, Hogg R, Kehlet H, Kessler P, Kopp S PMID 34433647
• Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3. PMID 23392233

Идентификаторы

NCT: NCT06982625 · ANESTH-03-2024 · 2024-A02290-47

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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