PERINEURAL LOCAL ANAESTHETIC CATHETER AFTER MAJOR LOWER LIMB AMPUTATION TRIA

Phase 1

• Conditions: Analgesia 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 procedures; MedDRA version: 19.1Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 19.1Level: SOCClassification code 10018065Term: General disorders and administration site conditionsSystem Organ Class: 10018065 - General disorders and administration site conditions; MedDRA version: 19.1Level: SOCClassification code 10022117Term: Injury, poisoning and procedural complicationsSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2016-003544-37-GB
• Lead Sponsor: Aneurin Bevan University Health Board

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-10
• Study Completion: 2018-08-31
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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.

Patients who met the inclusion criteria but who subsequently are not suitable for randomisation include:
• patients where a planned major amputation was not performed (due to either anaesthetic or surgical difficulties)
• patients where a major amputation was performed but the appropriate nerve was not identified
• patients who, due to instability in the intra-operative period, require admission to the ICU postoperatively and are most likely to be sedated for more than 24 hours
• patients who, due to instability in the intra-operative period, are not expected to survive more than two weeks

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified