Major lower limb amputation Circulatory System
Conditions
Interventions
All patients recruited into the study have been scheduled to receive either an above knee or below knee amputation for complications of peripheral vascular disease. The treatment arm will receive a p
a non-coring needle with a slight curve at its tip which causes a catheter passed through the needle to exit at approximately 45 degrees which is used to place the catheter in the correct location. T
Sponsors
Aneurin Bevan University Health Board
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 years or older 2. Undergoing elective or emergency major lower limb amputations (BKA, or AKA) for complications of PVD 3. Able to assess pain using a VRS 4. Those with a life expectancy of greater than two weeks 5. (For women of childbearing potential) willing to undergo a pregnancy test before the trial and agree to either use a highly effective method of contraception or abstain from sexual intercourse until at least seven days after their amputation
Exclusion criteria
Exclusion criteria: 1. Patients undergoing digital, metatarsal, tarsal amputation, disarticulation of the hip or hindquarter amputation 2. Patients undergoing simultaneous bilateral amputations 3. Patients undergoing through knee amputation (TKA) 4. Patients who are unable to provide consent due to incapacity (as defined by Mental Capacity Act 2005) 5. Vulnerable or protected adults 6. Patients with an allergy or intolerance to any of the substances in the PNC, or local anaesthetic agents, or chronically taking class IB anti-arrhythmic agents or local anaesthetic agents, for example in the form of transdermal patches. 7. Pregnant females 8. Patients expected to be managed in the intensive care unit (ICU) postoperatively and be sedated for more than 24 hours 9. Patients undergoing a subsequent amputation who have already been enrolled to participate in the PLACEMENT trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain experienced over the first 5 days after surgery, as assessed using a Verbal Rating Scale (VRS), which will be captured 3 times a day | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain, assessed by the Overall Benefit of Analgesia Score (OBAS) pre-operatively and once daily post-operatively for five days 2. Pain, assessed by the Self-completed Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) pre-operatively and on postoperative day five 3. Opioid use, measured pre-operatively and once daily postoperatively for five days, converted to morphine equivalents using the University of Alberta Multidisciplinary Pain Centre Opioid Conversion Guide 4. Pain, assessed by OBAS, S-LANSS and the Modified Groningen Phantom Limb Pain questionnaire at six week and six month follow-up 5. Quality of life, assessed pre-operatively and at 6 week and 6 month follow-up using EQ-5D and HADS. 6. Surgical site infection rates, classified as per the 2008 CDC/NHSN document 7. Rate of successful identification of the nerve and successful placement of the PNC (the latter in the intervention group only) 8. Assessment of resource usage during the first 6 months postoperatively | — |
Countries
United Kingdom, Wales
Outcome results
None listed