Spine disease
Conditions
Interventions
Trade Name: Canemes 1 mg Kapseln
Pharmaceutical Form: Capsule
INN or Proposed INN: Nabilone
CAS Number: 510022 - 71-
Other descriptive name: Nabilone
Concentration unit: mg milligram(s)
Concentration
Sponsors
OA Dr. Philipp Becker c/o Abteilung für Wirbelsäulenchirurgie, Orthopädisches Spital Speising GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent • Indication for a spinal fusion surgery • Suspected availability within the max.120 day period of study participation • No identification of any exclusion criterion Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
Exclusion criteria: 1) Non-completion of the 18th year of life 2) Detention (for a court or administrative order), accommodation (under Unterbringungsgesetz) or (already made or in the) appointment of a trustee 3) Limited contractual capability 4) Military service 5) Pregnancy and not excluded pregnancy (women of childbearing potential) 6) Risk of the occurrence of pregnancy during the study participation (in women the absence of at least one of the following criteria: onset of menopause more than 2 years ago, postmenopausal sterilization, surgical sterilization, use of a reliable method of contraception for the duration of the study with hormones, intrauterine device (coil) or diaphragm / condom + spermicide) 7) Lactation 8) HADS-Anxiety> 8 9) HADS-Depression> 8 10) Treatment with a cannabinoid or consumption of cannabis or analogous substances within the past 6 months 11) Contraindication for nabilone 12) Start of opioid therapy in the last week 13) (except for the investigational drug:) Foreseeable treatment with cannabinoids or consumption of cannabis or analogous substances during study participation 14) Absolute contraindication for the use of postoperative medication required to be applied (Mexalen®, Tradolan®, Dipidolor® and Zofran Zydis®) 15) Unsatisfactory treatability of pain resulting from multiple contraindications for the use of analgesics and analgesics classes 16) Foreseeable compliance problems 17) Concomitant disease with the potential for a relevant short-term improvement or worsening of pain and mental state 18) Participation in another study with insurance cover 19) Running processes for early retirement / long-term sick leave 20) (Except for the surgery-related hospitalization:) planned hospital stay within the next four months (incl. stays preceding surgery at other Departments of the Orthopedic Hospital Speising)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Gaining first insights into the effects of pre-, peri- and postoperative cannabinoid intake on the physical and psychological coping with surgery as well as on the pain perception of patients with severely reduced quality of life;Secondary Objective: Gaining first insights into the effects of pre-, peri- and postoperative cannabinoid intake on the physical and psychological coping with surgery as well as on the pain perception of patients with severely reduced quality of life;Primary end point(s): Prior-ranking endpoints: • Change in HADS anxiety (U1 to U2, U1 to U7, U1 to U8) [-] • Change in HADS depression (U1 to U2, U1 to U7, U1 to U8) [-] • Change in SF36 mental sum score (U1 to U2, U1 to U7, U1 to U8) [-] • Change in SF36 physical sum score (U1 to U2, U1 to U7, U1 to U8) [-] • Change in Oswestry Disability Questionnaire Low Back Pain (U1 to U2, U1 to U7, U1 to U8) [-] • Change in FABQ (U1 to U2, U1 to U7, U1 to U8) [-] • Change in FABQ-subscore work (U1 to U2, U1 to U7, U1 to U8) [-] • Change in FABQ-subscore physical activity (U1 to U2, U1 to U7, U1 to U8) [-] • Change in pinprick pain threshold (U1 to U2, U1 to U3, U1 to U5, U1 to U7, U1 to U8) [mN];Timepoint(s) of evaluation of this end point: U1 = First examination in the morning of the surgery preparation day U2 = Examination in the morning of the day before the surgery U3 = Examination in the morning of postop. day 2 U4 = Examination in the morning of postop. day 5 U5 = Examination in the morning of dismissal day (not before postop. day 6) U6 = Examination (telephone call) in the morning of postop. day 21 U7 = Examination in the morning of postop. day 42 U8 = Last examination in the morning of postop. day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): further selected endpoints: • HADS anxiety at U2, U7 and U8) [-] • HADS depression at U2, U7 and U8) [-] • SF36 mental sum score at U2, U7 and U8) [-] • SF36 physical sum score at U2, U7 and U8) [-] • Oswestry Disability Questionnaire Low Back Pain at U2, U7 and U8) [-] • FABQ at U2, U7 and U8) [-] • FABQ-subscore work at U2, U7 and U8) [-] • FABQ-subscore physical activity at U2, U7 and U8) [-] • Pinprick pain threshold at U2, U3, U4, U5, U7 and U8 [mN] • analgesics consumption from end of surgery until U4, from end of surgery until U5, from U5 until U7 and from U5 until U8 [ standard] • duration of hospitalization [days] • ICU length of stay [days] • Items 1-n of the questionnaire on personal attitude at U7;Timepoint(s) of evaluation of this end point: see E 5.1.1 | — |
Countries
Austria
Contacts
Public ContactPatientinnen- und Patientenanwalt
Wiener Pflege-, Patientinnen- und Patientenanwaltschaft
Outcome results
None listed