No registrations found.
ID
Source
Brief title
Health condition
The Ehlers-Danlos syndrome is a group of rare genetic disorders caused by a defect in collagen synthesis. Several patients from the EDS patient organisation claimed that for them regional and local anesthesia did not work properly. Up to now there is no proof or explenation for this phenomenon.
Sponsors and support
Intervention
Outcome measures
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.
Background summary
N/A
Study objective
Locoregional anesthesia does not work as well in patients with the Ehlers-Danlos syndrome as in people who do not have this syndrome.
Study design
N/A
Intervention
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%.
P.O. Box 85500,
Heidelberglaan 100
J.C. Mier
Utrecht 3584 CX
The Netherlands
+31 (0)30 2509111
jmier@umcutrecht.nl
P.O. Box 85500,
Heidelberglaan 100
J.C. Mier
Utrecht 3584 CX
The Netherlands
+31 (0)30 2509111
jmier@umcutrecht.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL780 |
| NTR-old | NTR791 |
| Other | : N/A |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |