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    Summary
    EudraCT Number:2013-001160-38
    Sponsor's Protocol Code Number:lidocaineplif
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-07-29
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2013-001160-38
    A.3Full title of the trial
    Impact of intravenous lidocaine infusion on postoperative analgesia for one or two level posterior lumbar interbody fusion surgery
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    a study to evaluate the effect on pain after surgery of the back after addition of an extra pain killer during operation
    A.4.1Sponsor's protocol code numberlidocaineplif
    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 SponsorZNA Middelheim
    B.1.3.4CountryBelgium
    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 supportZNA Middelheim
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationZNA Middelheim
    B.5.2Functional name of contact pointMarie Van Remoortere
    B.5.3 Address:
    B.5.3.1Street AddressLindendreef 1
    B.5.3.2Town/ cityAntwerp
    B.5.3.3Post code2020
    B.5.3.4CountryBelgium
    B.5.4Telephone number323280 31 96
    B.5.6E-mailmarie.van.remoortere@gmail.be
    D. IMP Identification
    D.IMP: 1
    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 Linisol 2%
    D.2.1.1.2Name of the Marketing Authorisation holderbraun
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    Intravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlidocaine
    D.3.9.1CAS number 6108-05-0
    D.3.9.3Other descriptive nameLIDOCAINE HYDROCHLORIDE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB02922MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    D.8.3Pharmaceutical form of the placeboInjection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The postoperative pain intensity after posterior interbody fusion surgery is often intense and difficult to treat with IV morphine and paracetamol alone. Besides, the use of opioids is often associated with important side effects. The aim of this research project is to evaluate the impact of a lidocaine infusion during surgery and during the first 4 postoperative hours on postoperative pain intensity and morphine consumption for one or two level posterior interbody fusion
    E.1.1.1Medical condition in easily understood language
    Do patients who undergo fusion surgery of the lower back have less pain after surgery when an extra pain killer is added during surgery.
    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 16.0
    E.1.2Level PT
    E.1.2Classification code 10050505
    E.1.2Term Spinal fusion surgery
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10050237
    E.1.2Term Operative spinal fusion
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10041575
    E.1.2Term Spinal fusion
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary endpoints
    - Postoperative pain intensity
    - Postoperative opioid consumption
    E.2.2Secondary objectives of the trial
    Secondary endpoints:
    - Patient satisfaction on the 3rd postoperative day
    - Incidence of side-effects postoperatively
    - Amount of days until the patient can walk 50 meters independently
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General inclusion criteria for the study
    - Physical status ASA I-II (Table 1), aged between 18 and 75 years
    - indications for surgery: degenerative anterolysthesis with or without spinal stenosis, degenerative disc disease with or without spinal stenosis and spondylosis with or without lysthesis
    E.4Principal exclusion criteria
    Primary exclusion criteria
    - ASA III-IV
    - Known allergy to local anesthetics
    - History of drug or alcohol abuse
    - Hepatic failure (defined as a history of cirrhosis or fulminant hepatic failure)
    - Chronic renal failure (defined as serum creatinine >2mg/dl)
    - Pregnancy
    - Breast feeding
    - Psychiatric disorder
    E.5 End points
    E.5.1Primary end point(s)
    - Postoperative pain intensity (NRS)
    - Postoperative opioid consumption (cumulative dose in mg/24h)
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Preoperative pain scores (NRS) are registered for leg and back pain.
    Postoperatively, NRS will be noted at 30 minutes, 1, 4 and 6 hours after arrival at the PACU (day 0). On the following postoperative days (day 1 -3), NRS will be measured 3 times daily.
    - The postoperative morphine consumption will be registered every 24 hours and will be expressed as a cumulative dose.
    E.5.2Secondary end point(s)
    - Patient satisfaction on the 3rd postoperative day
    - Incidence of side-effects postoperatively
    - Amount of days until the patient can walk 50 meters independently
    E.5.2.1Timepoint(s) of evaluation of this end point
    - For assessment of the satisfaction about the postoperative pain management: NRS, identifying 10 as ‘extremely satisfied’ and 0 as ‘very dissatisfied’. Will be measured at the 3th postoperative day by asking the patient one question: “How satisfied are you about the pain management of the last 3 days”?

    - The side effects will be scored as follows: For the opioid related side effects, the Opioid Related Symptom Distress Scale (ORSDS) questionnaire will be filled in once daily from day 1 until the 3th postoperative day. On the day of surgery, sedation will be scored by the nurses at the same time points as the pain scoring (at 30 minutes, 1, 4 and 6 hours after surgery) using the POSS scale
    The incidence of cardiovascular side effects are noted daily (yes/no) and specified.

    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 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 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) 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 Yes
    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 Yes
    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 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
    last patient
    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 months
    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: 84
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 Yes
    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 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 state84
    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)
    not different from normal treatment
    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 Decision2013-09-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2025-01-30
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