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    Summary
    EudraCT Number:2021-005889-17
    Sponsor's Protocol Code Number:WATOS-PE
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2023-02-09
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2021-005889-17
    A.3Full title of the trial
    PAIN CONTROL WITH THE USE OF WALANT IN TOTAL TRAPEZECTOMY. RANDOMIZED CLINICAL TRIAL
    CONTROL DEL DOLOR CON EL USO DE WALANT EN LA TRAPEZECTOMIA TOTAL. ENSAYO CLÍNICO ALEATORIZADO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of WALANT anesthetic modality with general anesthesia with regional block for the treatment of rhizartosis with total trapezectomy. Randomized Clinical Trial.
    Comparación de la modalidad anestésica de WALANT con la anestesia general con bloqueo regional para el tratamiento de rizartosis con trapecectomía total. Ensayo Clínico Aleatorizado.
    A.3.2Name or abbreviated title of the trial where available
    WATOS-PE
    A.4.1Sponsor's protocol code numberWATOS-PE
    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 SponsorFundació Institut d'Investigació i Innovació Parc Taulí (I3PT)
    B.1.3.4CountrySpain
    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 supportFundació Institut d'Investigació i Innovació Parc Taulí (I3PT)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundació Institut d'Investigació i Innovació Parc Taulí (I3PT)
    B.5.2Functional name of contact pointCEIm Parc Taulí
    B.5.3 Address:
    B.5.3.1Street AddressParc Taulí 1
    B.5.3.2Town/ citySabadell
    B.5.3.3Post code08208
    B.5.3.4CountrySpain
    B.5.4Telephone number+34937458451
    B.5.6E-mailceic@tauli.cat
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameLIDOCAINE 1%
    D.3.2Product code LIDOCAINE 1%
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLIDOCAINE 1%
    D.3.9.1CAS number 73-78-9
    D.3.9.3Other descriptive nameLIDOCAINE 1%
    D.3.9.4EV Substance CodeSUB12644MIG
    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 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.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameADRENALINE TARTRATE
    D.3.2Product code ADRENALINE TARTRATE
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNADRENALINE TARTRATE PH. EUR.
    D.3.9.2Current sponsor codeADRENALINE TARTRATE
    D.3.9.3Other descriptive nameADRENALINE TARTRATE PH. EUR.
    D.3.9.4EV Substance CodeSUB176490
    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: 3
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameSODIUM BICARBONATE
    D.3.2Product code SODIUM BICARBONATE
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSODIUM BICARBONATE BP
    D.3.9.2Current sponsor codeSODIUM BICARBONATE
    D.3.9.3Other descriptive nameSODIUM BICARBONATE BP
    D.3.9.4EV Substance CodeSUB169196
    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: 4
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameMepivacaine
    D.3.2Product code Mepivacaine
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMepivacaine
    D.3.9.1CAS number 96-88-8
    D.3.9.2Current sponsor codeMepivacaine
    D.3.9.3Other descriptive nameMepivacaine
    D.3.9.4EV Substance CodeSUB14514MIG
    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: 5
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameLEVOBUPIVACAINA
    D.3.2Product code LEVOBUPIVACAINA
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLevobupivacaine hydrochloride
    D.3.9.1CAS number 27262-48-2
    D.3.9.2Current sponsor codeLevobupivacaine
    D.3.9.3Other descriptive nameLevobupivacaine hydrochloride
    D.3.9.4EV Substance CodeSUB02904MIG
    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: 6
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    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 namePROPOFOL
    D.3.2Product code PROPOFOL
    D.3.4Pharmaceutical form Emulsion for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracavernous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPropofol
    D.3.9.2Current sponsor codePropofol
    D.3.9.3Other descriptive namePropofol
    D.3.9.4EV Substance CodeSUB10116MIG
    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: 7
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameFentanyl
    D.3.2Product code Fentanyl
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFentanyl
    D.3.9.2Current sponsor codeFentanyl
    D.3.9.3Other descriptive nameFentanyl
    D.3.9.4EV Substance CodeSUB07597MIG
    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: 8
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameMIDAZOLAM
    D.3.2Product code MIDAZOLAM
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMidazolam
    D.3.9.1CAS number 59467-70-8
    D.3.9.2Current sponsor codeMidazolam
    D.3.9.3Other descriptive nameMidazolam
    D.3.9.4EV Substance CodeSUB08950MIG
    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
    Thumb trapeziometacarpal joint osteoarthritis treated by total trapeziectomy
    Rizartrosis tratada con cirugía de trapecectomía total
    E.1.1.1Medical condition in easily understood language
    osteoarthritis of the base of the thumb treated surgically with excision of the trapezium
    artrosis de la base del pulgar tratada quirúrgicamente con la escisión del trapecio
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    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
    The primary objective of the study is to evaluate pain in the first 24h after Thumb trapeziometacarpal joint osteoarthritis surgery by total trapezectomy with the use of the WALANT modality as compared to the usual anesthetic modality, which is regional block and general anesthesia.
    El objetivo principal del estudio es evaluar el dolor en las primeras 24h después de la intervención quirúrgica de rizartrosis mediante trapecectomía total con el uso de la modalidad WALANT comparado con la modalidad anestésica habitual de bloqueo regional y anestesia general.
    E.2.2Secondary objectives of the trial
    Secondary objectives are:
    - To evaluate pain control in the postoperative 48h and oral analgesia consumption.
    - To evaluate the level of patient satisfaction with the process.
    - To evaluate the clinical outcome with the Patient Rated Wrist Evaluation (PRWE) scale at 1 month, 3 months, 6 months and 12 months post-intervention.
    - To study preoperative and intraoperative prognostic factors that may influence functional outcomes.
    - To evaluate intraoperative and postoperative complications.
    Los objetivos secundarios son:
    - Evaluar el control del dolor en las 48h postoperatorias y el consumo de analgesia oral.
    - Evaluar el nivel de satisfacción del proceso por parte del paciente.
    - Evaluar el resultado clínico con la escala PRWE (Patient Rated Wrist Evaluation) al 1er mes, a los 3 meses, a los 6 y a los 12 meses post-intervención.
    - Estudiar factores pronósticos prequirúrgicos e intraquirúrgicos que puedan influir en los resultados funcionales
    - Evaluar las complicaciones intraquirúrgicas y post-quirúrgicas
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients over 18 years of age.
    - Clinical and radiological diagnosis of trapeziometacarpal arthropathy.
    - Surgical indication of total trapeziometacarpal arthropathy to be performed in the outpatient operating room.
    - Patients or their legal representatives accept the informed consent.
    - Pacientes mayores de 18 años.
    - Diagnóstico clínico y radiológico de artropatía trapeziometacarpiana.
    - Indicación quirúrgica de trapecectomía total que se realize en quirófano ambulatorio.
    - Pacientes o representantes legales de este acepten el consentimiento informado.
    E.4Principal exclusion criteria
    - Allergy to local anesthetics and vasoconstrictor agents.
    - Concomitant surgery on the same hand or wrist.
    - Need for hospitalization after surgery.
    - Patient with high demand that requires another type of intervention other than a total trapezectomy.
    - Pregnancy or breast-feeding
    - Patients who, at the investigator's discretion, are not good candidates for the study (e.g., inability to comply with the follow-up program, comorbidity, poor physical or mental health in general, drug abuse problems or alcohol....).
    - Alergia a anestésicos locales y agentes vasoconstrictores.
    - Intervención quirúrgica concomitante en la misma mano o muñeca
    - Necesidad de ingreso tras la intervención quirúrgica.
    - Paciente con alta demanda que requiera otro tipo de intervención diferente a una trapezectomía total.
    - Embarazo o en periodo de lactancia
    - Pacientes que, a criterio del investigador, no sean buenos candidatos para el estudio (ej. Incapacidad para cumplir el programa de seguimiento, comorbilidad, mala salud física o mental en general, problemas de abuso de drogas o alcohol....).
    E.5 End points
    E.5.1Primary end point(s)
    - Pain on VAS scale (0-10, where 0 is no pain and 10 is the maximum level of pain) 24h after the surgical procedure. By telephone. Collected by one of the investigators (outside the hand surgery department) who will act as a blinded evaluator. The mean will be used as the central estimator and the standard deviation.
    • Dolor en escala EVA (0-10, dónde 0 es nada de dolor y 10 es el máximo nivel de dolor) a las 24h del procedimiento quirúrgico. Vía telefónica. Recogida por uno de los investigadores (ajeno al departamento de cirugía de la mano) que actuará como evaluador ciego. Se utilizará la media como estimador central y la desviación estándar.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24h
    24h
    E.5.2Secondary end point(s)
    - Pain on VAS scale at 48h after the surgical procedure. By telephone.
    - Number of analgesic pills taken in the first 24h.
    - Number of analgesic pills taken between 24 and 48h.
    - Side effects derived from the elastomeric pump and/or analgesic medication.
    - PRWE (Patient Rated Wrist Evaluation) scales at 1 month, 3 months, 6 months and 1 year. This questionnaire includes sections on pain and function evaluation in specific activities of the anatomical region of the hand and daily activities.
    - Presence of intraoperative and wound complications.
    - Re-admissions to the emergency department for evaluation related to the surgical procedure and/or poor pain control.
    • Dolor en escala EVA a las 48h del procedimiento quirúrgico. Vía telefónica.
    • Número de pastillas analgésicas tomadas en las primeras 24h.
    • Número de pastillas analgésicas tomadas entre las 24 y 48h
    • Efectos secundarios derivados de la bomba elastomérica y/o medicación analgésica.
    • Escalas PRWE (Patient Rated Wrist Evaluation) al mes, a los 3 meses, a los 6 meses y al año. Este cuestionario incluye apartados de evaluación de dolor y función en actividades específicas de la región anatómica de la mano y actividades cuotidianas.
    • Presencia de complicaciones intraoperatorias y de la herida.
    • Re admisiones en urgencias por evaluación relacionada con el procedimiento quirúrgico y/o por mal control del dolor.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - 48Hours
    - 3 months after surgery
    - 6 months after surgery
    - 12 months after surgery
    - 48 horas
    - 3 meses después de la cirugía
    - 6 meses después de la cirugía
    - 12 meses después de la cirugía
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    a
    a
    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) Yes
    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 No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 Yes
    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
    LVLS
    LVLS
    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
    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: 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.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
    Ninguno
    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 Decision2023-05-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-13
    P. End of Trial
    P.End of Trial StatusCompleted
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