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The Ehlers-Danlos syndrome and regional anesthesia.


- candidate number2283
- NTR NumberNTR791
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-okt-2006
- Secondary IDsN/A 
- Public TitleThe Ehlers-Danlos syndrome and regional anesthesia.
- Scientific TitleThe Ehlers-Danlos syndrome and regional anesthesia.
- ACRONYMN/A
- hypothesisLocoregional 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 criteriaFor 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 criteriaFor 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 receivedno
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-nov-2006
- planned closingdate1-nov-2007
- Target number of participants50
- Interventions1. 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 outcomeAnalgesia 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 outcome1. 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.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDrs. J.C. Mier
- CONTACT for SCIENTIFIC QUERIESDr. A.J.M. Wijck, van
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD10-okt-2006 - 13-jan-2010


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