Trial of locally injected pain medication for post-operative recovery after knee replacement surgery

Phase 1

Conditions: ocal anaesthetic for patients undergoing knee replacement surgery for arthritis
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2016-003154-32-GB

Lead Sponsor: niversity of Leeds

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 500

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To see how well a new local anaesthetic (pain killer), liposomal bupivacaine, works when compared to a standard pain killer, bupivacaine hydrochloride, that is routinely injected at the time of knee replacement surgery. ;Secondary Objective: To assess other aspects of patient recovery both in short and long term recovery using a range of patient-reported and objective outcome measures.<br>To evaluate the cost effectiveness of liposomal bupivacaine compared with the current standard of care.<br><br><br>;Primary end point(s): Quality of Recovery 40 Score at 72 hours. <br><br>Cumulative daily pain score at rest using VAS 0 to 72 hours.<br><br><br>;Timepoint(s) of evaluation of this end point: 72 hours following surgery (known as day 0, 1, 2 and 3)

Secondary Outcome Measures