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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03606915
Other study ID # B-ER-104-070
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 10, 2015
Est. completion date December 31, 2019

Study information

Verified date February 2020
Source National Cheng-Kung University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Measure the cytokines, transforming or neurotrophic factors in CSF and plasma as the pain markers and as a new therapeutic target for pain control.


Description:

The research protocol was approved by the Institutional Review Board (IRB) for the Protection of Human Subjects at National Cheng Kung University Hospital (NCKUH/B-ER-104-070). The study procedures were performed according to the rules of IRB and fully explained to the participants. Blood and CSF samples were collected and compared the difference in no pain group, acute pain group, and chronic pain group.


Recruitment information / eligibility

Status Completed
Enrollment 131
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years to 90 Years
Eligibility Inclusion Criteria:

- . Patients undergo spinal anesthesia

- . Over 20 years of age

- Patients who are competent to understand the study and provide written informed consent.

Exclusion Criteria:

- Patients have the contraindication for spinal anesthesia (refuse spinal anesthesia, coagulopathy, severe aortic stenosis)

- Refuse participated in this study or pre-existent neurological disease.

- Patients with advanced tumor staging (stage 3 or 4).

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
pain evaluation
collect CSF during spinal anesthesia

Locations

Country Name City State
Taiwan National Cheng Kung University Tainan

Sponsors (1)

Lead Sponsor Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary cytokine measurement in cerebrospinal fluid cytokine measurement ( via ELISA) in cerebrospinal fluid through study completion, an average of 1 year
Primary cytokine measurement in blood cytokine measurement (via ELISA) in blood through study completion, an average of 1 year
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