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    Summary
    EudraCT Number:2016-003544-37
    Sponsor's Protocol Code Number:ABUHB/01/0816/1
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-04-10
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2016-003544-37
    A.3Full title of the trial
    Perineural Local Anaesthetic Catheter aftEr Major lowEr limb amputatioN Trial (PLACEMENT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PERINEURAL LOCAL ANAESTHETIC CATHETER AFTER MAJOR LOWER LIMB AMPUTATION TRIAL
    A.3.2Name or abbreviated title of the trial where available
    PLACEMENT
    A.4.1Sponsor's protocol code numberABUHB/01/0816/1
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN85710690
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAneurin Bevan University Health Board
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportResearch for Patient and Public Benefit (RfPPB), Health and Care Research Wales
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAneurin Bevan University Health Board
    B.5.2Functional name of contact pointChristopher Twine
    B.5.3 Address:
    B.5.3.1Street AddressVascular Institute, Royal Gwent Hospital
    B.5.3.2Town/ cityCardiff Road, Newport
    B.5.3.3Post codeNP20 2UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01633 234234
    B.5.6E-mailchristopher.twine@wales.nhs.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Chirocaine
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameChirocaine
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPPerineural use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLevobupivacaine hydrochloride
    D.3.9.1CAS number 27262-47-1
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Analgesia for lower limb amputation for peripheral vascular disease (PVD)
    E.1.1.1Medical condition in easily understood language
    Pain relief for lower leg amputation
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level SOC
    E.1.2Classification code 10042613
    E.1.2Term Surgical and medical procedures
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level SOC
    E.1.2Classification code 10021881
    E.1.2Term Infections and infestations
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level SOC
    E.1.2Classification code 10018065
    E.1.2Term General disorders and administration site conditions
    E.1.2System Organ Class 10018065 - General disorders and administration site conditions
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level SOC
    E.1.2Classification code 10022117
    E.1.2Term Injury, poisoning and procedural complications
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The principal research question is whether it is feasible to run a pragmatic randomised controlled trial to investigate the effect of a PNC use plus usual care compared to usual care alone on post-operative pain.
    E.2.2Secondary objectives of the trial
    Secondary objectives include:
    • estimate an effect size for the difference in pain scores between groups for powering a future Randomised Clinical Trial (RCT)
    • identify barriers to patient recruitment and site set up
    • identify the proportion of eligible participants who consent to the study
    • identify the proportion of patients who supply primary outcome data
    • identify what frequency of pain score measurements, and using which tool, are most suited to identify pain in this cohort of patients
    • identify the proportion of patients reaching follow up to evaluate Phantom Limb Pain and Chronic Stump Pain levels
    • identify which secondary outcomes are important to include, and how best to assess them
    • identify important outcomes for patients and doctors (Core Outcome Sets: COS) for amputation research
    • develop a deeper understanding of overall patient experience relating to pain, and pain management
    • develop a suitable framework for a full health economic evaluation in a future RCT
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    E.4Principal 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
    E.5 End points
    E.5.1Primary end point(s)
    Our primary outcome will be pain experienced over the first 5 postoperative days, as assessed using a Verbal Rating Scale with range 0 to 10, which will be captured 3 times a day.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 times per day for the first 5 days after operation for lower limb amputation.
    E.5.2Secondary end point(s)
    Secondary outcomes are:
    • Pain assessed by the Overall Benefit of Analgesia Score (OBAS) pre-operatively and once daily post-operatively for five days.
    • Pain assessed by the Self-completed Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) pre-operatively and on post-operative day five.
    • Opioid use measured pre-operatively and once daily post-operatively for five days, converted to morphine equivalents using the University of Alberta Multidisciplinary Pain Centre Opioid Conversion Guide.
    • Pain assessed by S-LANSS and the Groningen PLP questionnaire at six week and six month follow-up.
    • Quality of life assessed pre-operatively and at 6 week and 6 month follow-up using EQ-5D and HADS.
    • Surgical site infection rates classified as per the 2008 CDC/NHSN document.
    • Rate of successful identification of the nerve and successful placement of the PNC (the latter in the intervention group only).
    • Assessment of resource usage during the first 6 months post-operatively.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Various timepoints ranging from pre-operative, daily post-operative, at day 5 post-operative, 6 weeks and 6 months.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Usual care
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The date of last data capture defines the end of the trial. This will be the date of the last data capture for the 6 month follow-up appointment with the last recruited subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The intervention is short term by its very nature, so there is no problem of its potential 'withdrawal' from participants following cessation of the study.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Cardiff University
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-11-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-08-31
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