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

The effect of spinal anesthesia on pain perception and sedation in healthy volunteers

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26547
Enrollment
16
Registered
2013-07-18
Start date
2013-06-21
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pain processing endogenous pain modulation sedation verwerken van pijnprikkels endogene pijnstilling sedatie

Interventions

We will perform fMRI scans and experimental pain tests prior to and after spinal anesthesia at the level of L4/5.

Sponsors

LUMC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Healthy male volunteers, aged 18 to 45 years, right-handed

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
fMRI analysis, BOLD response.

Secondary

MeasureTime frame
experimental heat pain, performed with the Pathway (Medoc Ltd, Ramat Yishai, Israel), a device that is able to heat a probe to a predefined temperature.

Contacts

Public ContactL.C.J. Oudejans

Afdeling anesthesiologie P5-46 Albinusdreef 2

L.C.J.Oudejans@lumc.nl+31 (0)71 5262301

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)