ISRCTN72547749
Active, not recruiting
Phase 3
Perineural Local Anaesthetic Catheter aftEr Major lowEr limb amputatioN Trial (PLACEMENT)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Cardiff University
- Enrollment
- 650
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Current participant inclusion criteria as of 02/07/2024:
- •1\. Aged 18 years or older
- •2\. Undergoing elective or emergency MLLA (BKA, TKA, or AKA) for complications of PAD, diabetes, or acute or chronic infection
- •3\. Able to assess pain using NRS
- •4\. Life expectancy of greater than two weeks
- •5\. (For people of childbearing potential) Willing to undergo a preoperative pregnancy test and agree to either use a highly effective method of contraception or abstain from sexual intercourse for 7 days after MLLA.
- •6\. (For male participants with female sexual partners who are considered to be of childbearing potential)\* Willing to agree to use a condom or abstain from sexual intercourse for seven days after MLLA
- •Previous participant inclusion criteria:
- •1\. Aged 18 years or older
- •2\. Undergoing elective or emergency MLLA (BKA, TKA, or AKA) for complications of PAD and/or diabetes
Exclusion Criteria
- •Current participant exclusion criteria as of 02/07/2024:
- •1\. Undergoing MLLA for trauma or cancer
- •2\. Undergoing digital, metatarsal, tarsal amputation, disarticulation of the hip or hindquarter amputation
- •3\. Undergoing simultaneous bilateral amputations
- •4\. Undergoing MLLA revision (excluding previous guillotine amputation)
- •5\. Allergy or intolerance to the PNC or local anaesthetic agents, or chronically taking class 1B anti\-arrhythmic agents or local anaesthetic agents, for example in the form of transdermal patches.
- •6\. Expected to be sedated for more than 24 hours postoperatively
- •7\. Unable to provide consent due to incapacity (as defined by the Mental Capacity Act 2005\)
- •8\. Vulnerable or protected adults.
- •9\. People who are currently pregnant or breastfeeding
Outcomes
Primary Outcomes
Not specified
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