Comparison of Epidural Analgesia With Intra-Articular Infiltration Analgesia

Официальное название

Comparison of Epidural Analgesia With Intra-Articular Infiltration Analgesia for Postoperative Total Knee Arthroplasty Analgesia: A Prospective, Randomized Controlled Trial

Обзор

The results of combining infiltrative analgesia applied by orthopedists with epidural analgesia applied by anesthesiologists after knee replacement surgery will be compared. It aims to compare epidural analgesia with the maximum reduction of postoperative pain in patients, as well as in terms of both analgesic and complications. The study will include patients who have undergone knee replacement surgery for six months. In the study, we will compare the results of painkillers applied to the patient from the waist or knee after the waist numbing anesthesia, which includes some of the routinely applied protocols of your knee replacement surgery. It is a condition that will be monitored after surgery. The study aims to reduce maximum pain with two painkiller methods applied in small amounts or together. No interventional application will be made to the patient who will undergo surgery other than routine application. After the surgery, you will be asked verbally about your pain level and side effects at certain hours after the surgery and the amount of painkillers used and the amount of painkillers will be determined according to the follow-up hours (1st, 2nd, 6th, 12th, 24th and 48th hours after the surgery). In addition to these, complications will also be monitored. The results of patients who can be fully followed up at the end of 6 months will be presented as a scientific study.

Вмешательства

• Другое Recording the amount of medication and the number of complications according to observational follow-up
  Observational monitoring of patients and recording data for 24 hours

Первичные конечные точки

• Amount of local anesthetic used for epidural analgesia [Срок оценки: 6 months]
• Differences between the two groups in terms of complications and need for additional analgesia [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Age range 18-75
• Those who underwent surgery with combined spinal anesthesia
• Drugs administered with combined spinal anesthesia and intra-articular infiltration analgesia

Критерии исключения

• Those who do not want to participate in the study
• Those who underwent surgery under general anesthesia
• Patients outside the specified age range
• Patients with inadequate follow-up results (patient, drug and device related)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Berninger MT, Friederichs J, Leidinger W, Augat P, Buhren V, Fulghum C, Reng W. Effect of local infiltration analgesia, peripheral nerve blocks, general and spinal anesthesia on early functional recovery and pain control in total knee arthroplasty. BMC Musculoskelet Disord. 2018 Jul 18;19(1):232. doi: 10.1186/s12891-018-2154-z. PMID 30021587
• Liu X, Zhang H, Zhang H, Guo M, Gao Y, Du C. Local infiltration vs epidural analgesia for postoperative pain control after total knee or hip arthroplasty: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2020 Oct 30;99(44):e22674. doi: 10.1097/MD.0000000000022674. PMID 33126306

Идентификаторы

NCT: NCT06872528 · NamikKU-AGultekin-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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