iposomal bupivacaine in knee replacement surgery

Phase 3

Completed

• Conditions: Elective orthopaedic surgery; Musculoskeletal Diseases

• Registration Number: ISRCTN54191675
• Lead Sponsor: niversity of Leeds

Brief Summary

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31842977 protocol (added 18/12/2019) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35385072/ (added 07/04/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-14
• Study Completion: 2021-02-28
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 533

Inclusion Criteria

Current participant inclusion criteria as of 11/01/2019:
1. Unilateral primary knee replacement, including both total knee replacement (TKR) and unicompartmental knee replacement (UKR), for end-stage osteoarthritis
2. American Society of Anaesthesiologists (ASA) Grade I to III
3. Participant is willing and able to consent for themselves
4. Male or female, aged 18 years or above
5. In the Investigator’s opinion, is able and willing to comply with all trial requirements

Previous participant inclusion criteria as of 26/10/2018:
1. Unilateral primary knee replacement, including both total knee replacement (TKR) or unicompartmental knee replacement (UKR), for end stage osteoarthritis
2. Willing and able consent for themselves
3. Male or female, aged 18 years or above
4. In the Investigator’s opinion, is able and willing to comply with all trial requirements.

Previous participant inclusion criteria:
1. Participant is willing and able consent for themselves
2. Male or Female, aged 18 years or above
3. End stage osteoarthritis of the knee
4. In the Investigator’s opinion, is able and willing to comply with all trial requirements

Exclusion Criteria

Current participant exclusion criteria as of 11/01/2019:
1. Allergy or intolerance to amide-type local anaesthetics
2. Objective evidence of nerve damage in the affected lower limb
3. Rheumatoid arthritis
4. 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 results of the trial, or the participant’s ability to participate in the trial
5. Participants who have participated in another research trial involving an investigational product in the past 6 months
6. Participants who have significant cognitive impairment or language issues
7. Contra-lateral knee replacement within the trial or within 12 months prior to randomization

Previous participant exclusion criteria as of 26/10/2018:
1. American Society of Anaesthesiologists (ASA) Grade III or above
2. Allergy or intolerance to amide type local anaesthetics
3. Objective evidence of nerve damage in the affected lower limb
4. Rheumatoid arthritis
5. 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 results of the trial, or the participant’s ability to participate in the trial
6. Participants who have participated in another research trial involving an investigational product in the past 6 months
7. Participants who have significant cognitive impairment or language issues
8. Contra-lateral knee replacement within the trial or within 12 months prior to randomisation

Previous participant exclusion criteria:
1. American Society of Anaesthesiologists (ASA) Grade III or above
2. Allergy or intolerance to amide type local anaesthetics
3. Objective evidence of nerve damage in the affected lower limb
4. Rheumatoid arthritis
5. 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.
6. Participants who have participated in another research trial involving an investigational product in the past 6 months
7. Participants who have significant cognitive impairment or language issues
8. Contra-lateral knee replacement (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
• Study Design: Not specified