chronic pain in terminal cancer
Conditions
Interventions
In this study a video endoscope will be added to the cordotomy in two consecutive parts.
Study part A: Just like with the regular cordotomy technique a cannula will be inserted in the spinal space un
Sponsors
UMC Groningen, Dept. of Anaesthesiology
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age = 18 years old ; 2. Unilateral (refractory) cancer related pain below dermatome C5; 3. Numeric Rating Scale (NRS) = 4; 4. Pharmacological therapy offers no or insufficient relief (anymore) and/or has too many side effects; 5. Life expectancy maximum 1 – 2 years; 6. Understanding of the Dutch language .
Exclusion criteria
Exclusion criteria: 1. Cordotomy in medical history; 2. Bilateral pain of equal etiology; 3. Coagulation disorder or increased bleeding tendency; 4. Increased intracranial pressure; 5. Known allergy to iodine (because contrast medium administration (Lipiodol)); 6. Unable to lie still on the operating table (~ 45-60 minutes); 7. Unable to communicate adequately during procedure; 8. Absolute contraindications MR imaging. 9. Enrolled in any other clinical study within the duration of the current study; 10. Incapable of giving consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure will be safety measured by (S)AE, side effects and complications documentation. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes include feasibility of the video endoscope (identification of anatomical structures and technical equipment), feasibility regarding preoperative MRI (identification of anatomical structures), effectiveness regarding pain relief (NRS and BPI), effectiveness regarding QoL (EORTC QLQ-C15-PAL, PGIC and HADS) and postoperative assessment of the thermolesion (MRI report). | — |
Contacts
Public ContactT.F. Buisman
Universitair Medisch Centrum Groningen
Outcome results
None listed