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Het effect van de ruggenprik op pijn perceptie en sedatie in gezonde vrijwilligers


- candidate number15153
- NTR NumberNTR4071
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-jul-2013
- Secondary IDsP13.070 
- Public TitleHet effect van de ruggenprik op pijn perceptie en sedatie in gezonde vrijwilligers
- Scientific TitleThe effect of spinal anesthesia on pain perception and sedation in healthy volunteers
- ACRONYMSAPP
- hypothesisSpinal anesthesia induces several alterations in normal brain processes. Firstly, loss of afferent information increases pain sensitivity. In our previous study on the effects of spinal anesthesia (P11.221) we showed that subjects felt more pain upon heat stimulation during spinal anesthesia. This increase in pain sensitivity was explained by alterations in the endogenous pain modulation system, which is an important regulator of pain perception. Secondly, clinical evidence suggests that the loss of afferent information from the spinal cord has significant effects on the maintenance of the arousal state. For example, spinal anesthesia coincides with the development of a decrease in the necessary dose of intravenous or inhalational anesthesia to reach a defined level of sedation. Furthermore, an increased level of sedation has been shown in healthy volunteers with spinal anesthesia. The aim of the current study is to extend and specify the results seen in our previous study within specific pain processing brain areas with task-related fMRI data, and to evaluate experimental pain sensitivity and sedation after spinal anesthesia.
- Healt Condition(s) or Problem(s) studiedSedation, Endogenous pain modulation, Pain processing
- Inclusion criteriaHealthy male volunteers, aged 18 to 45 years, right-handed
- Exclusion criteria- Obesity (BMI > 30);
- Significant history of any cardiac or vascular disorder, asthma or other pulmonary disease, major gastrointestinal abnormalities, peptic ulceration, hepatic, neurological, psychiatric, hematological (including bleeding disorders), endocrine, renal, or major genitourinary disease;
- 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;
- History of chronic alcohol or illicit drug use;
- 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;
- Claustrophobia;
- Allergy to study medications;
- Not able to maintain a regular diurnal rhythm.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 21-jun-2013
- planned closingdate21-feb-2014
- Target number of participants16
- InterventionsWe will perform fMRI scans and experimental pain tests prior to and after spinal anesthesia at the level of L4/5.
- Primary outcomefMRI analysis, BOLD response.
- Secondary outcomeexperimental heat pain, performed with the Pathway (Medoc Ltd, Ramat Yishai, Israel), a device that is able to heat a probe to a predefined temperature.
- Timepointspre and post spinal scans (day 1 or 2) and control condition scans (day 1 or 2).
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES L.C.J. Oudejans
- CONTACT for SCIENTIFIC QUERIES L.C.J. Oudejans
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summarySpinal anesthesia induces several alterations in normal brain processes. Firstly, loss of afferent information increases pain sensitivity. Secondly, clinical evidence suggests that the loss of afferent information from the spinal cord has significant effects on the maintenance of the arousal state.

In this study the effects of deafferentation on pain perception and sedation will be further investigated by 1) performing task-related functional MRI and 2) performing behavioral pain tests to evaluate endogenous pain modulation.

Task-related fMRI: To determine the specific effects of deafferentation, two task-related fMRI scans will be performed to (1) detect the specific process of altered pain perception in the brain; and (2) measure reaction time as marker for sedation and identify alterations in brain regions involved in this process.

Endogenous pain modulation: A disbalance between pain facilitation and pain inhibition alters pain sensitivity and plays an important role in the chronification of pain. To evaluate the effect of deafferentation on the endogenous pain modulation system two experimental expressions of this system will be investigated known as the “Conditioned pain modulation” and “Offset analgesia” paradigm [10].

Aims:
(1) To assess the effect of deafferentation on pain processing in the brain by task-fMRI
(2) To assess the effect of deafferentation on reaction time (sedation) by task-fMRI
(3) To assess the effect of deafferentation on endogenous pain modulation
- Main changes (audit trail)
- RECORD18-jul-2013 - 22-jul-2013


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