Effects Of Intra-Operative Intra-Articular Cocktail Injection In Patella Open Reduction And Internal Fixation

Официальное название

Effects Of Intra-Operative Intra-Articular Cocktail Injection In Patella Open Reduction And Internal Fixation (ORIF): A Single Centre, Double Blinded, Randomised Control Trial

Обзор

The objective of this study is to demonstrate the safety and efficacy of an intra-articular analgesics cocktail injection for post-operative patella fracture fixation patients, by comparing post-operative pain relief and functional recovery among study subjects who received the injection and those who did not receive the injection. Secondary objective is to demonstrate the health economic effects of intra-articular analgesics cocktail injection by reducing length of hospital stay and reducing bed-stay related complications.

Подробное описание

This is a single-centre, double-blinded, randomised control trial that evaluates the efficacy of intra-articular analgesics cocktail injection in post-operative pain relief and functional recovery for fractured patella fixation patients. The recruited study subjects will be randomised to the two study groups respectively in a 1:1 randomisation ratio.

Patella is the largest sesamoid bone in the human body, it acts as the fulcrum of our knee extensor apparatus and is important during the gait cycle. Patella fracture commonly occurs after a fall on a flexed knee. Treatment can be conservative or surgical with open reduction and internal fixation. Patients often experience significant pain around the knee post-operatively, limiting their walking ability and hindering their rehabilitation. As a result, total hospital stay will be prolonged, leading to hospital stay-related morbidity and additional healthcare economic burden.

Previous studies have shown that the use of an analgesic cocktail injection in arthroplasty cases can significantly reduce early postoperative pain and provide better early motion. The cocktail regime is as follows for a unilateral joint:

Ketoralac 15mg Ropivacaine 1% 15ml 0.9% Normal Saline 35ml Adrenaline 1:1000 0.5ml Stacort-A Triamcinolone Acetonide 40mg Total Cocktail Volume \~50ml

After fracture fixation, patients in the intervention group will receive an intra-articular injection of the above analgesic cocktail, while patients in the control group will not receive an injection.

Herein this study, the investigators hope to demonstrate the safety and efficacy of an intra-articular analgesics cocktail injection for post-operative patella fracture fixation patients.

Вмешательства

• Препарат Ketorolac 15mg
  An intra-articular cocktail injection ( Ketoralac 15mg, Ropivacaine 1% 15ml, 0.9% Normal Saline 35ml, Adrenaline 1:1000 0.5ml, Stacort-A Triamcinolone Acetonide 40mg) will be injected into the surgical site after fracture fixation surgery.
• Препарат Triamcinolone Acetonide 40mg
  An intra-articular cocktail injection ( Ketoralac 15mg, Ropivacaine 1% 15ml, 0.9% Normal Saline 35ml, Adrenaline 1:1000 0.5ml, Stacort-A Triamcinolone Acetonide 40mg) will be injected into the surgical site after fracture fixation surgery.
• Препарат Ropivacaine HCL 1% 15ml
  An intra-articular cocktail injection ( Ketoralac 15mg, Ropivacaine 1% 15ml, 0.9% Normal Saline 35ml, Adrenaline 1:1000 0.5ml, Stacort-A Triamcinolone Acetonide 40mg) will be injected into the surgical site after fracture fixation surgery.
• Препарат 0.9 % Normal Saline 35ml
  An intra-articular cocktail injection ( Ketoralac 15mg, Ropivacaine 1% 15ml, 0.9% Normal Saline 35ml, Adrenaline 1:1000 0.5ml, Stacort-A Triamcinolone Acetonide 40mg) will be injected into the surgical site after fracture fixation surgery.
• Препарат Adrenaline 1:1000 0.5ml
  An intra-articular cocktail injection ( Ketoralac 15mg, Ropivacaine 1% 15ml, 0.9% Normal Saline 35ml, Adrenaline 1:1000 0.5ml, Stacort-A Triamcinolone Acetonide 40mg) will be injected into the surgical site after fracture fixation surgery.

Первичные конечные точки

• Pain as measured by Numerical Patient Reported Scale (NRPS) [Срок оценки: Pre-op, Post-op Day 1 to 3]
• Maximum Active Knee Flexion [Срок оценки: At post-op Day 1 to 3]
• Oral analgesics consumed [Срок оценки: Post-operative 2 weeks period]
• Tegner Lysholm Knee Score [Срок оценки: Post-op Day 14]
• Knee Injury and Osteoarthritis Outcome Score (KOOS) [Срок оценки: Post-op Day 14]
• 9-item Quality of Recovery Score (QoR-9 Score) [Срок оценки: Post-op Day 1 to 3]

Вторичные конечные точки (3)

• Length of hospital stay [Срок оценки: Through study completion, an average of 1 year]
• Time to radiological bony union [Срок оценки: Through study completion, an average of 1 year]
• Incidence of Complications [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

• acute patella fracture requiring open reduction and internal fixation;
• able to consent to surgery;
• pre-morbid able to ambulate

Критерии исключения

• open fracture;
• polytrauma;
• previous knee arthroplasty;
• history of chronic pain,
• insulin-dependent diabetes mellitus, or peptic ulcer disease;
• chronic users of glucocorticoids, immunosuppressants, or immune-modulating agents, or of strong opioids (e.g.: morphine, fentanyl, hydromorphone, methadone, oxycodone, or meperidine);
• hepatitis B or C carrier;
• renal impairment (creatinine \[Cr\], >200 mmol/L)

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

Гонконг · 1 центр

• Queen Mary Hospital, The University of Hong Kong — Гонконг

Публикации

• Baid M, Narula S, Manara JR, Blakeney W. Evolution in the Management of Patella Fractures. J Clin Med. 2024 Feb 29;13(5):1426. doi: 10.3390/jcm13051426. PMID 38592262
• Petrie J, Sassoon A, Langford J. Complications of patellar fracture repair: treatment and results. J Knee Surg. 2013 Oct;26(5):309-12. doi: 10.1055/s-0033-1353990. Epub 2013 Aug 16. PMID 23955187

Идентификаторы

NCT: NCT07006168 · UW 24-611

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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