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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04417608
Other study ID # N202003147
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 4, 2020
Est. completion date July 4, 2021

Study information

Verified date June 2020
Source Taipei Medical University WanFang Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

For patients who undergoing hemodialysis, it is important to have good AV fistula. One third of AV fistula usually fail during early stage. It is helpful to use nerve block to dilate the blood vessels and enhance the prognosis. But 0.2% Ropivacaine usually cause muscle weakness in present studies. The investigators hope to find the lowest concentration to provide sympathectomy without muscle weakness. Because the patients with hemodialysis usually have multiple co-morbidity, thus we choose patients with forearm fracture at the first place. With this result, the investigators can design further study for patients with hemodialysis. The investigators prefer proximal approach because brachial plexus run together in the cosctoclavicular space and show lower incidence of incomplete work.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 66
Est. completion date July 4, 2021
Est. primary completion date July 4, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Age between 20-80 y/o, BW: 40-90 kilograms,ASA class I-III,No pre-existing neuropathy,Scheduled for upper limb surgery.

Exclusion Criteria:

1. Pre-existing neuropathy (ex: polyneuropathy)

2. History of allergy to xylocaine?ropivacaine?epinephrine

3. Emergent surgery

4. Coagulopathy

5. Patient who can not express themselves

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Infraclavicular brachial plexus block
Ultrasound-guided infraclavicular brachial plexus block

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University WanFang Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Change of diameter of basilic vein and brachial artery Use ultrasound to measure the difference of diameter at different time point. Change from baseline diameter(pre-nerve block) at 45min
Primary Change of diameter of basilic vein and brachial artery Use ultrasound to measure the difference of diameter at different time point. Change from baseline diameter(pre-nerve block) at 24hour
Primary Change of diameter of basilic vein and brachial artery Use ultrasound to measure the difference of diameter at different time point. Change from baseline diameter(pre-nerve block) at 48hour
Secondary Sensory block of upper limb A validated 3-point scale was used: 0 = no block (patient has normal sensation), 1 = patient can feel cold, but the sensation is reduced compared with the unblocked side, and 2 = complete anesthesia. 45min post nerve block
Secondary Sensory block of upper limb A validated 3-point scale was used: 0 = no block (patient has normal sensation), 1 = patient can feel cold, but the sensation is reduced compared with the unblocked side, and 2 = complete anesthesia. 24hour post nerve block
Secondary Motor block of upper limb A validated 3-point scale was used: 0 = no block (patient has normal power), 1 = patient can feel weakness with the unblocked side, and 2 = complete anesthesia. 45min post nerve block
Secondary Motor block of upper limb A validated 3-point scale was used: 0 = no block (patient has normal power), 1 = patient can feel weakness with the unblocked side, and 2 = complete anesthesia. 24hour post nerve block
Secondary Motor block of upper limb A validated 3-point scale was used: 0 = no block (patient has normal power), 1 = patient can feel weakness with the unblocked side, and 2 = complete anesthesia. 48hour post nerve block