EUCTR2016-003544-37-GB
Active, not recruiting
Phase 1
Perineural Local Anaesthetic Catheter aftEr Major lowEr limb amputatioN Trial (PLACEMENT) - PLACEMENT
ConditionsAnalgesia for lower limb amputation for peripheral vascular disease (PVD)MedDRA version: 19.1Level: SOCClassification code 10042613Term: Surgical and medical proceduresSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 19.1Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 19.1Level: SOCClassification code 10018065Term: General disorders and administration site conditionsSystem Organ Class: 10018065 - General disorders and administration site conditionsMedDRA version: 19.1Level: SOCClassification code 10022117Term: Injury, poisoning and procedural complicationsSystem Organ Class: 10022117 - Injury, poisoning and procedural complicationsTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
DrugsChirocaine
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Analgesia for lower limb amputation for peripheral vascular disease (PVD)
- Sponsor
- Aneurin Bevan University Health Board
- Enrollment
- 50
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The following patients are suitable for inclusion into the study:
- •patients aged 18 years or older
- •undergoing elective or emergency major lower limb amputations (BKA, or AKA) for complications of PVD
- •able to assess pain using a VRS
- •those with a life expectancy of greater than two weeks
- •(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.
- •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 10
Exclusion Criteria
- •The following patients are not suitable for inclusion into the study:
- •patients undergoing digital, metatarsal, tarsal amputation, disarticulation of the hip or hindquarter amputation
- •patients undergoing simultaneous bilateral amputations
- •patients undergoing through knee amputation (TKA)
- •patients who are unable to provide consent due to incapacity (as defined by Mental Capacity Act 2005\)
- •vulnerable or protected adults
- •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.
- •pregnant females
- •patients expected to be managed in the intensive care unit (ICU) postoperatively and be sedated for more than 24 hours
- •patients undergoing a subsequent amputation who have already been enrolled to participate in the PLACEMENT trial.
Outcomes
Primary Outcomes
Not specified
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