SPAARK: Study of Peri-Articular Anaesthetic for Replacement of the Knee.The clinical and cost effectiveness of peri-articular liposomal bupivacaine compared with bupivacaine hydrochloride alone for post-operative recovery after knee replacement surgery: A multi-centre, patient-blinded, randomised controlled trial. - Liposomal bupivacaine in knee replacement surgery

niversity of Leeds0 个研究点目标入组 500 人开始时间: 2017年4月26日最近更新: 2024年9月9日

适应症

试验速览

暂无简介。

•Unilateral primary knee replacement, including both total knee replacement (TKR) or unicompartmental knee replacement (UKR), for end stage osteoarthritis
•American Society of Anaesthesiologists (ASA) Grade I to III
•Participant is willing and able consent for themselves
•Male or female, aged 18 years or above.
•In the Investigator’s opinion, is able and willing to comply with all trial requirements.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 250
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 250

•Allergy or intolerance to amide type local anaesthetics
•Objective evidence of nerve damage in the affected lower limb.
•Rheumatoid arthritis
•Any other significant disease, disorder or condition which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial.
•Participants who have participated in another research trial involving an investigational product in the past 6 months.
•Participants who have significant cognitive impairment or language issues
•Contra-lateral knee replacement within the trial or within 12 months prior to randomisation
•(If the patient is receiving staged bilateral knees, they may still participate in the trial but data will only be included from the first knee)

发起方

niversity of Leeds