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

The effect of spinal anesthesia on pain perception and sedation in healthy volunteers - the SAPP study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON38807
Enrollment
16
Registered
2013-06-12
Start date
2013-06-21
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

(chronische) neuropathische pijn chronic pain neuropathic pain

Interventions

spinal anesthesia

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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 measures (BOLD signal) pain intensity (VAS)in response to a noxious thermal stimulus reaction time after a cognitive test

Secondary

MeasureTime frame
n.v.t.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)