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    Summary
    EudraCT Number:2015-000229-35
    Sponsor's Protocol Code Number:2015/01
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-03-05
    Trial 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 ConcernedIreland - HPRA
    A.2EudraCT number2015-000229-35
    A.3Full title of the trial
    A prospective randomised control trial comparing local anaesthetic subcutaneous wound injection versus local anaesthetic wound percolation in distal forearm fractures
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of post-operative pain relief for local anaesthetic (LA) 0.5% Bupivacaine is administered to a patient prior to the closure of surgical wound for a distal forearm fracture using:
    Method 1. Injection of LA subcutaneously around the wound site, prior to wound closure, while the patient is under a general anaesthetic.
    or
    Method 2. Percolation of LA directly into wound cavity, prior to wound closure, while the patient is under a general anaesthetic. No needle used
    A.4.1Sponsor's protocol code number2015/01
    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 SponsorBeaumont Hospital
    B.1.3.4CountryIreland
    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 supportBeaumont Hospital
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBeaumont Hospital
    B.5.2Functional name of contact pointLaura Ann Lambert
    B.5.3 Address:
    B.5.3.1Street AddressBeaumont Hospital
    B.5.3.2Town/ cityBeaumont
    B.5.3.3Post codeDublin 9
    B.5.3.4CountryIreland
    B.5.4Telephone number00353180930002299
    B.5.6E-maillauraannlambert@rcsi.ie
    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 Marcain Heavy Steripack, 0.5%w/v Solution for Injection
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca UK Ltd
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 nameMarcain Heavy Steripack, 0.5%w/v Solution for Injection
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Marcain Heavy Steripack, 0.5%w/v Solution for Injection
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca UK Ltd
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 nameMarcain Heavy Steripack, 0.5%w/v Solution for Injection
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfiltration
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Fracture of distal radius or ulna
    E.1.1.1Medical condition in easily understood language
    Fracture of one of the bones of the forearm near the wrist
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. Evaluation of post-operative pain scores at 3, 6 & 12 hours using the Visual Analogue Scale* and comparison of the outcomes of both treatment arms to assess for a statistical significance.

    2. Retrospective audit of opiate consumption in the 12 hours post operatively and comparison of the outcomes of both treatment arms to assess for a statistical significance.
    E.2.2Secondary objectives of the trial
    1. Completion of a psychological assessment(s) e.g STAI, pre operatively to assess predisposing personality traits and compare to the results of pain scores & opiate consumption (Primary Objectives 1&2)
    2. Retrospective analysis of cost difference and potential cost saving.
    3. Assessment of any potential risk reduction of needle stick injury.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol
    - Subjects must be male or female, aged 18 -74 years
    - Diagnosed with a distal wrist fracture of the radius or ulna requiring a single incision for open reduction and internal fixation.
    - Subjects who are judged fit to undergo a general anaesthesia for operative treatment
    - Female subjects' urine pregnancy test performed at the screening period must be negative.
    E.4Principal exclusion criteria
    - Allergy/sensitivity to Bupivacaine
    - Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study.
    - Subjects who have participated in another study and received any other investigational agent within 30 days.
    - Subjects unable to provide written informed consent and unable to have witnessed consent to a mark provided by their non-dominant hand by a person not connected to the study
    - Subjects who have any other significant disease or disorder (including uncontrolled diabetes, unstable ischemic heart disease, moderate to severe congestive heart failure, recent cerebrovascular accident) which, in the opinion of the investigator, may either put the subject at risk by participation in the study, or may influence the result of the study.
    - Subjects who have a history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements.
    - Aged greater than 74 years
    - Aged less than 18 years
    - Distal wrist fracture radius and ulna requiring > 1 incision for open reduction and internal fixation
    - Increased volume of local anaesthetic (>10mls Bupivacaine Hydrochloride 0.5%w/v Solution for Injection, advised to be administered as per the discretion of the anaesthetist or surgeon during the treatment period for the benefit of the study participant.
    - In receipt of regularly prescribed opiates for pain other than their current injury
    - Pregnant Women
    E.5 End points
    E.5.1Primary end point(s)
    1.Mean clinically important difference in pain as per VAS Scores in LA percolation arm compared to LA subcutaneous injection arm.

    2.Increased frequency of requirement for opiates in the LA percolation arm compared to the LA subcutaneous injection arm.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. At 3, 6 & 12 hours post operatively
    2. Consecutive 12 hours post operatively
    E.5.2Secondary end point(s)
    1. Reduced cost or equal direct cost of giving local anaesthetic solution
    2. Higher levels of anxiety experienced by participants across both treatment arms in patients requiring more PRN analgesia and experiencing greater pain using VAS
    3. Absolute avoidance of needle stick injury to deliver local anaesthetic.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At time of treatment
    2. Post completion of inventory & retrospective review of opiate consumption and VAS
    3. At time of treatment
    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 No
    E.6.4Safety No
    E.6.5Efficacy Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Determine the efficacy of one IMP given in two different ways. Method 1- subcutaneous injection. Method 2- Wound infiltration with local anaesthetic solution
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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
    The IMP is delivered in 2 different ways- subcutaneous injection versus wound infiltration
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    Last visit of last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 89
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    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 Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    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 state89
    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)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-07-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-03
    P. End of Trial
    P.End of Trial StatusCompleted
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