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    Summary
    EudraCT Number:2017-005200-96
    Sponsor's Protocol Code Number:ZUH-LAP-HEMI-TQL
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-01-15
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2017-005200-96
    A.3Full title of the trial
    Improving perioperative pain management for laparoscopic surgery due to colon cancer using the ultrasound-guided Transmuscular Quadratus Lumborum block. A double blind, randomized, placebo controlled trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Improving pain management for minimal invasive surgery due to colon cancer using an ultrasound-guided nerve block.
    A.4.1Sponsor's protocol code numberZUH-LAP-HEMI-TQL
    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 SponsorAssociate Professor, Consultant Jens Børglum
    B.1.3.4CountryDenmark
    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 supportDepartment of Anaesthesiology, Zealand University Hospital, Roskilde
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Anaesthesiology, Zealand University Hospital, Roskilde
    B.5.2Functional name of contact pointJens Børglum
    B.5.3 Address:
    B.5.3.1Street AddressSygehusvej 10
    B.5.3.2Town/ cityRoskilde
    B.5.3.3Post code4000
    B.5.3.4CountryDenmark
    B.5.4Telephone number4530700120
    B.5.6E-mailjedn@regionsjaelland.dk
    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 Ropivacain
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfiltration
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRopivacain
    D.3.9.3Other descriptive nameROPIVACAINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB04264MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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 placeboInfiltration
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Postoperative pain following laparoscopic hemicolectomy or sigmoidectomy due to coloncancer
    E.1.1.1Medical condition in easily understood language
    Postoperative pain after minimal invasive surgery due to colon cancer.
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10009951
    E.1.2Term Colon cancer NOS
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10078463
    E.1.2Term Laparoscopic partial colectomy
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10054711
    E.1.2Term Postoperative pain
    E.1.2System Organ Class 100000004863
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    We wish to conduct a randomized, controlled and double blind study, comparing the effect of the TQL-block vs. placebo. Our aim with this study is to investigate the efficacy of the TQL block vs. placebo in patients undergoing laparoscopic surgery due to colon cancer. Our hypothesis is, that the bilateral TQL block will significantly reduce the opioid consumption during the first 24 postoperative hours and significantly reduce the Numerical Rating Scale (NRS) pain score (0-10) and opioid related side effects. We will furthermore obtain blood samples in the perioperative period. We will analyse them to characterize the differences in the immunologic stress response to colorectal surgery between the groups.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age > 18
    • Scheduled for laparoscopic hemicolectomy or sigmoidectomy due to colon cancer
    • Have received thorough information, oral and written, and signed the “Informed Consent” form on participation in the trial
    • ASA 1-3
    E.4Principal exclusion criteria
    • Inability to cooperate
    • Inability to speak and understand Danish
    • Allergy to local anaesthetics or opioids
    • Daily intake of opioids (evaluated by the investigators)
    • Local infection at the site of injection or systemic infection
    • Difficulty visualisation of muscular and fascial structures in ultrasound visualisation necessary to the block administration
    • Pregnant* or breastfeeding
    • Daily use of oral or intravenous steroids
    • Known immune deficiency (evaluated by the investigators)
    • Other simultaneous or previous cancer diagnosis (except non-melanoma skin cancer)
    E.5 End points
    E.5.1Primary end point(s)
    Total morphine consumption in the first 24 hours postoperatively (data from PCA pump and patient medical record).
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 hours post surgery
    E.5.2Secondary end point(s)
    • Pain intensity (NRS 0-10) in the study period at 24 hours postoperatively. Pain scores a registered upon arrival at the PACU at T0 and again 30 min, 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 hours postoperative. Pain intensity will be registered during mobilization (sitting up) and at rest. In addition, NRS score will be recorded electronically on all morphine administrations, since all patients must enter their NRS score on the PCA pump display prior to administration of the PCA boluses.
    • Morphine consumption at 6, 12, 18 postoperative hours.
    • Duration of block (time to first opioid).
    • The degree of morphine-related side effects (PONV, itching, fatigue, etc.).
    • Time from surgery to first mobilization.
    • Quality of Recovery – 15 questionnaire at four time points (day -1, 1,2 and at the time of pathology results) the patients are asked to fill in the validated Quality of Recovery Questionnaire QoR-15(36). The QoR-15 questionnaire results in a score of 0–150. These outcome measures will be correlated with changes in immunologic outcome measures in the perioperative period.
    • Surgical complications classified using the Clavien-Dindo classification within the first 30 days after surgery

    To characterize the immunological response to surgery we obtain blood samples for analysis on postoperative day -1, 1, 2 and at the visit on day 10-14, where pathology results are given according to the study plan described in figure 2. We will perform the following analyses:
    • Whole blood gene expression profiling
    • Peripheral blood mononuclear cells (PBMC)
    • Cytokine assays
    E.5.2.1Timepoint(s) of evaluation of this end point
    From admittance the day before surgery, when the first blood sample is drawn and until 30 days post surgery.
    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 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 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 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 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
    30 days post surgery for the last subject included in the trail
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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: 14
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 Yes
    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 state64
    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 Decision2018-03-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-01-03
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