No registrations found.
ID
Source
Brief title
Health condition
- spinal anesthesia
- deafferentiation
Sponsors and support
Intervention
Outcome measures
Primary outcome
Resting-state fMRI.
Secondary outcome
1. Heat pain tests (heat probe on lower arm);
2. Sedation scoring (self test and observer test);
3. Block height.
Background summary
The influence of spinal injection on brain connectivity is not known. In this placebo-controlled randomized study healthy male right-handed volunteers will be injected wiht 3 mL bupivacaine 0.5% in the spinal space. Next resting-state fMRI will be obtained 1 and 2 hours after infection. The effect of deafferentiation on pain and sedation will be tested using heat pain tests and sedation self scoring and the Observer’s Assessment of Alertness/Sedation Scale (OAA/S).
Study objective
1. The deafferentiation during spinal anesthesia changes the connectivity in resting-state networks in healthy volunteers;
2. The deafferentiation during spinal anesthesia changes pain perception and has sedetive effects.
Study design
1. Resting state fMRI: At baseline and at 1 and 2 hours after spinal infusion;
2. Heat pain tests: At baseline and at timepoint 15,30,45,90,105,150 minutes after spinal infusion;
3. Sedation scoring: At baseline and at timepoint 15,30,45,90,105,150 minutes after spinal infusion;
4. Block height: At baseline and at 10,20,30,45,90,105,150 minutes after spinal infusion.
Intervention
Spinal anesthesia at the level of L3-L4 with 3 mL bupivacaine 0.5% after local anesthesia with lidocaine 1%. Placebo will exist of local anesthesia with lidocaine after which a punction will take place to mimic the spinal punction.
The spinal anesthesia will last 4-5 hours. fMRi and arterial spin labeling will be performed 1 and 2 hours after anesthesia. Betweens these scans, heat pain tests will be performed on the forearm to evaluate the effect of spinal anesthesia on pain perception in areas not affected by the anesthesia.
Department of Anesthesiology,
P.O. Box 9600
Albert Dahan
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262301
a.dahan@lumc.nl
Department of Anesthesiology,
P.O. Box 9600
Albert Dahan
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262301
a.dahan@lumc.nl
Inclusion criteria
Healthy male, right handed volunteers between 18 and 45 years old.
Exclusion criteria
1. Obesity (BMI > 30);
2. Significant history of any cardiac or vascular disorder, asthma or other pulmonary disease, major gastrointestinal abnormalities, peptic ulceration, hepatic, neurological, psychiatric, haematological (including bleeding disorders), endocrine, renal, or major genitourinary disease;
3. History of illness, condition or medication use that, in the opinion of the investigator, might interfere with optimal participation, confound the results of the study or pose additional risk in administering spinal anesthesia to the subject;
4. History of chronic alcohol or illicit drug use;
5. Metal medical devices like pacemakers, knee or hip prosthesis, ear implants, vessel clips, subcutaneous insulin pumps or carries metal particles (e.g. metal splinter in the eye) inside the body;
6. Claustrophobia;
7. Allergy to study medications;
8. Not able to maintain a regular diurnal rhythm.
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 | NL3330 |
| NTR-old | NTR3491 |
| Other | METC LUMC : P11-221 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |