|- candidate number||12914|
|- NTR Number||NTR3491|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-jun-2012|
|- Secondary IDs||P11-221 METC LUMC|
|- Public Title||The effect of spinal anesthesia on resting-state fMRI.|
|- Scientific Title||Spinal anesthesia-induced sedative and pronociceptive effects measured by resting-state fMRI: A study in healthy volunteers.|
|- hypothesis||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.
|- Healt Condition(s) or Problem(s) studied||Spinal anesthesia, Deafferentiation|
|- 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;
7. Allergy to study medications;
8. Not able to maintain a regular diurnal rhythm.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2012|
|- planned closingdate||1-okt-2012|
|- Target number of participants||12|
|- Interventions||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.
|- 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.
|- Timepoints||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.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. Albert Dahan|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. Albert Dahan|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|Leiden University Medical Center (LUMC)|
|- Brief 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 Observerís Assessment of Alertness/Sedation Scale (OAA/S).|
|- Main changes (audit trail)|
|- RECORD||19-jun-2012 - 6-jul-2012|