| - candidate number | 2283 |
| - NTR Number | NTR791 |
| - ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| - Date ISRCTN created | |
| - date ISRCTN requested | |
| - Date Registered NTR | 10-okt-2006 |
| - Secondary IDs | N/A |
| - Public Title | The Ehlers-Danlos syndrome and regional anesthesia. |
| - Scientific Title | The Ehlers-Danlos syndrome and regional anesthesia. |
| - ACRONYM | N/A |
| - hypothesis | Locoregional anesthesia does not work as well in patients with the Ehlers-Danlos syndrome as in people who do not have this syndrome. |
| - Healt Condition(s) or Problem(s) studied | |
| - Inclusion criteria | For the Ehlers-Danlos group: 1. people with all types of Ehlers-Danlos except type IV, proven by a geneticist or a comparably qualified person; 2. 18 to 65 years old; 3. informed consent. For the control group: All subjects are matched with a patient from the Ehlers-Danlos group for age and sexe. |
| - Exclusion criteria | For Ehlers-Danlos patients: 1. Type IV Ehlers-Danlos; 2. co-existing disease which increases the risk of locoregional anesthesia, according to prudent daily clinical practice; 3. hereditary acquired or drug induced bleeding disorders; 4. periferal mononeuropathy, polyneuropathy, multiple sclerosis or other relevant neurologic disorder. |
| - mec approval received | no |
| - multicenter trial | no |
| - randomised | no |
| - group | Parallel |
| - Type | 2 or more arms, non-randomized |
| - Studytype | intervention |
| - planned startdate | 1-nov-2006 |
| - planned closingdate | 1-nov-2007 |
| - Target number of participants | 50 |
| - Interventions | 1. An ulnar nerve block on the non-dominant arm with 3 ml lidocaine 2%; 2. application of 1.5 gram EMLA-cream on the dorsal side of the contralateral hand, covered with foil; 3. three times a fieldblock of 3 by 3 cm by means of three subcutaneous injections on the dorsal side of the thorax; one with lidocaine 1%, one lidocaine 2% and one with NaCl 0.9%. |
| - Primary outcome | Analgesia in the region of the ulnar nerve within 60 minutes after application of an ulnar nerve block.This will be demonstrated by increasing stimuli from a neurostimulator. If the subject does not regard 20 mA as painful there is of an adequate block. |
| - Secondary outcome | 1. Analgesia from the subcutanous injections and the topical application of EMLA cream; 2. Time of onset of analgesia; 3. Time of end of analgesia; 4. Duration of analgesia. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | stopped: trial finished |
| - CONTACT FOR PUBLIC QUERIES | Drs. J.C. Mier |
| - CONTACT for SCIENTIFIC QUERIES | Dr. A.J.M. Wijck, van |
| - Sponsor/Initiator | |
| - Funding (Source(s) of Monetary or Material Support) | |
| - Publications | N/A |
| - Brief summary | N/A |
| - Main changes (audit trail) | |
| - RECORD | 10-okt-2006 - 13-jan-2010 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl