Comparative Analgesic Effect After Total Knee Arthroplasty Between Intraosseous and Peri-articular Injection

Официальное название

Comparative Analgesic Effect After Total Knee Arthroplasty Between Intraosseous Multimodal Analgesic Agent Injection Versus Periarticular Injection - A Randomized Control Trial

Обзор

The goal of this RCT is to compare analgesic effect after total knee arthroplasty between intraosseous multimodal analgesic agent injection versus periarticular injection. The main question\[s\] it aims to answer are: Does Intraosseous multimodal analgesic cocktail injection have more post-operative analgesic effect than Peri-articular injection in patients who have done TKA (P)? Participants will randomized to intraosseous injection group or peri-articular injection group and will record the 100-mm VAS pain scores for 2 weeks after TKA. Researchers will compare to peri-articular injection group to see pain and functional outcomes after TKA.

Подробное описание

Intra-operatively, you will be randomly assigned to receive intraosseous multimodal analgesic agent injection or peri-articular multimodal analgesic agent injection along with other standard medications. In the intraosseous injection group: Participants received combinations of 0.5% bupivacaine 100 mg + 0.1% adrenaline 0.6 mg + Morphine 5mg + Ketorolac 30 mg (totally 22 ml) which divided by 12 ml inject into intramedullary canal before bone plug impaction to close the canal and 10 ml inject into metaphysis of tibia before cementation and implantation. In the peri-articualr injection group: Participants received combinations of the same drug and mix with normal saline solution for totally 75 ml which divided by 25 ml inject into medial gutter and 25 ml inject into lateral gutter before cementation and implantation. And the last 25 ml of multimodal analgesic drugs were injected into quadriceps.

Вмешательства

• Процедура Intraosseous Morphine
  Participants received combinations of 0.5% bupivacaine 100 mg + 0.1% adrenaline 0.6 mg + Morphine 5mg + Ketorolac 30 mg (totally 22 ml) which divided by 12 ml inject into intramedullary canal before bone plug impaction to close the canal and 10 ml inject into metaphysis of tibia before cementation and implantation
• Процедура Periarticular Injection
  Participants received combinations of 0.5% bupivacaine 100 mg + 0.1% adrenaline 0.6 mg + Morphine 5mg + Ketorolac 30 mg and mix with normal saline solution for totally 75 ml which divided by 25 ml inject into medial gutter and 25 ml inject into lateral gutter before cementation and implantation. And the last 25 ml of multimodal analgesic drugs were injected into quadriceps.

Первичные конечные точки

• pain scores [Срок оценки: at 4, 6 hours and every 6 hours after surgery for 2 days, then daily for 2 weeks after surgery.]

Вторичные конечные точки (9)

• Morphine consumption [Срок оценки: 2 weeks]
• number of vomit events [Срок оценки: at first 48 hours before discharge and after discharge for 2 weeks after surgery]
• Number of other Events of Morphine side effect [Срок оценки: 2 weeks after surgery]
• ROM [Срок оценки: before surgery and 24, 48hours and 2 weeks after surgery]
• Timed up and go test [Срок оценки: at 48 hours and 2 weeks after surgery]
• Length of stays in hospital [Срок оценки: up to 72 hours]
• Time to walk [Срок оценки: up to 48 hours]
• Operative time [Срок оценки: up to 2 hours]
• Number of other complication [Срок оценки: 2 weeks]

Критерии участия

Критерии включения

• 50 - 80 yrs of age ASA classification: 1-3 Unilateral TKA

Критерии исключения

• Secondary OA knee Previous knee surgery Can't undertaken spinal block and adductor canal block Renal insuf. (Crcl < 30 ml/min) History of convulsive disorder Abnormal liver function BMI > 35 Kg/M2 Allergy to study drugs History of coronary disease Hb < 10 (g/dl) Can't understand 100mm-VAS assessment Refuse to recruit in the study, or refuse follow up Using opioid in 5 days before surgery Unstable vital sign History current VTE Using anti-platelet or anti-coagulation medicine Severe deformity

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

Таиланд · 1 центр

• Thammasat University Hospital — Khlong Luang

Публикации

• McNamara CA, Laurita J, Lambert BS, Sullivan TC, Clyburn TA, Incavo SJ, Park KJ. A multimodal intraosseous infusion of morphine and ketorolac decreases early postoperative pain and opioid consumption following total knee arthroplasty. Knee. 2023 Aug;43:129-135. doi: 10.1016/j.knee.2023.06.002. Epub 2023 Jul 1. PMID 37399631
• Lamplot JD, Wagner ER, Manning DW. Multimodal pain management in total knee arthroplasty: a prospective randomized controlled trial. J Arthroplasty. 2014 Feb;29(2):329-34. doi: 10.1016/j.arth.2013.06.005. Epub 2013 Jul 11. PMID 23850410
• Brozovich AA, Incavo SJ, Lambert BS, Sullivan TC, Wininger AE, Clyburn TA, Taraballi F, Park KJ. Intraosseous Morphine Decreases Postoperative Pain and Pain Medication Use in Total Knee Arthroplasty: A Double-Blind, Randomized Controlled Trial. J Arthroplasty. 2022 Jun;37(6S):S139-S146. doi: 10.1016/j.arth.2021.10.009. Epub 2022 Mar 7. PMID 35272897

Идентификаторы

NCT: NCT06800846 · TUH Intraosseous injection TKA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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