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The effect of spinal anesthesia on resting-state fMRI.

Spinal anesthesia-induced sedative and pronociceptive effects measured by resting-state fMRI: A study in healthy volunteers.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22755
Enrollment
12
Registered
2012-06-19
Start date
2012-06-01
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

None listed

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 plac

Sponsors

Leiden University Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Healthy male, right handed volunteers between 18 and 45 years old.

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
Resting-state fMRI.

Secondary

MeasureTime frame
1. Heat pain tests (heat probe on lower arm); 2. Sedation scoring (self test and observer test); 3. Block height.

Contacts

Public ContactAlbert Dahan

Leiden University Medical Center (LUMC), Department of Anesthesiology, P.O. Box 9600

a.dahan@lumc.nl+31 (0)71 5262301

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)