Major lower limb amputation, including above- below- and through knee amputation, for complications of chronic diseases, including peripheral arterial disease and diabetes. Circulatory System
Conditions
Interventions
All participants recruited into the trial are scheduled to undergo either an above knee, below knee, or through knee amputation for complications of peripheral vascular disease or diabetes. The interv
Sponsors
Cardiff University
Eligibility
Sex/Gender
All
Inclusion 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 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
Exclusion criteria
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 10. Previously enrolled in PLACEMENT (excluding PLACEMENT feasibility trial) for a prior MLLA Previous participant exclusion criteria: 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 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 10. Previously enrolled in PLACEMENT (excluding PLACEMENT feasibility trial) for a prior MLLA
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from pain, defined as the proportion of time points with self-reported pain =3 using an 11-point Numeric Rating Scale (NRS, range 0 to 10) assessed twice daily for the first five postoperative days. | — |
Secondary
| Measure | Time frame |
|---|---|
| (Up to 5 days) 1. Participant satisfaction related to pain management during the preceding 24 h, assessed pre-operatively and once daily postoperatively for up to five days using a 4-point Likert scale 2. Opioid use assessed once daily postoperatively for five days, converted to morphine equivalents using the University of Alberta Multidisciplinary Pain Centre Opioid Conversion Guide 3. Opioid side effects (frequency and severity of symptoms) assessed once daily postoperatively for five days (At discharge) 4. Morbidity, assessed using Clavien-Dindo grading at discharge 5. Length of hospital stay (At 30 days) 6. Surgical site infection rates classified as per the 2008 CDC/NHSN document assessed at 30 days (At 90 days) 7. Days alive and out of hospital assessed at 90 days (DAOH-90) (At 3 to 6 months) 8. Chronic residual limb pain assessed at 3 and 6 months 9. Phantom limb pain assessed at 3 and 6 months 10. Length of hospital stay assessed at 3 and 6 months 11. Residual limb surgery assessed at 30 days, 3 months, and 6 months 12. Health-related QoL assessed using EQ-5D-5L at 3 months and 6 months 13. Participant reported anxiety and depression assessed using HADS at 3 months and 6 months 14. Prosthesis fitting assessed as rate and time to fitting using SIGAM at 3 and 6 months 15. Assessment of health care resource usage during the first 6 months postoperatively 16. Mortality assessed at 6 months. | — |
Countries
United Kingdom, Wales
Outcome results
None listed