E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Lumbar spinal stenosis |
Lumbale kanaalstenose |
|
E.1.1.1 | Medical condition in easily understood language |
Lumbar spinal stenosis |
wervelkanaalvernauwing |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10041595 |
E.1.2 | Term | Spinal stenosis lumbar |
E.1.2 | System Organ Class | 100000004859 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine whether epidural analgesia is superior to placebo, in reducing pain (measured in NRS) in patients after open lumbar decompression surgery. |
Onderzoeken of intra-operatieve epidurale pijnstilling superieur is aan een placebo in het verminderen van pijn bij patiënten die een interlaminaire decompressie ondergaan en of dit lijdt tot minder post-operatief opioïd gebruik in de eerste 48 uur na OK |
|
E.2.2 | Secondary objectives of the trial |
To determine whether epidural analgesia leads to a reduction in cumulative opioid use until 48 hours postoperatively To determine whether epidural analgesia leads to higher patient satisfaction than placebo. To determine whether epidural analgesia leads to shorter hospital stay. To determine whether epidural analgesia leads to less adverse events.
|
Onderzoeken of epidurale pijnstilling zorg voor minder morfinegebruik post-operatief, betere patiënttevredenheid, korter ziekenhuisverblijf en minder complicaties |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Indication for open interlaminar decompressive lumbar spine surgery. -Age over 18 years. -Psychosocially, mentally, and physically able to fully comply with this study protocol. -Informed consent prior to this study.
|
- indicatie voor open lumbale interlaminaire decompressie - leeftijd boven 18jaar - Psychosociaal, mentaal en fysiek in staat te voldoen aan het studieprotocol - toestemmingsverklaring getekend |
|
E.4 | Principal exclusion criteria |
-Pre-operative opiod use -Previous radiotherapy at the intended surgical level. -(Progressive) motor failure and/or anal sphincter disorders which urges instant intervention. -Active spinal infection. -Immature bone (ongoing growth). -Pregnancy. -Contra-indications for anesthesia or surgery. |
- Pre-operatief opioid gebruik - Eerdere radiotherapie in het te opereren gebied - Neurolgische uitval welke leidt tot spoedinterventie - Spinale infectie - Immatuur bot - zwangerschap - contra-indicaties anesthesie of operatie |
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E.5 End points |
E.5.1 | Primary end point(s) |
Postoperative pain scores (NRS) |
Postoperatieve pijnscores |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
recovery entry, recovery exit, 2, 4, 6, 12, 24 and 48 hours postoperative |
binnenkomst uitslaapkamer, vertrek uitslaapkamer, 2, 4, 6, 12, 24 en 48 uur postoperatief |
|
E.5.2 | Secondary end point(s) |
Total postoperative opioid consumption at 48 hours postoperatively with interim measurements at 2, 4, 6, 12 and 24 hours. Patient satisfaction (measured by QoR-40), hospital stay in days, number of adverse events. |
Totale postoperatieve opioid gebuik 48 uur postoperatie, patiënttevredenheid, duur ziekenhuisopname, aantal complicaties |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
opioid consumption: 48 hours postoperatively with interim measurements at 2, 4, 6, 12 and 24 hours. patient satisfaction: 24 hours after surgery Hospital stay in days adverse events 30 days after surgery |
Opioïd gebruik 48 uur patiënttevredenheid, 24 uur postOK ziekenhuisverblijf in dagen Complicaties eerste 30 dagen na OK |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial 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
|
30 days after last patiënt included and treated |
30 dagen na laatste inclusie |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |