NCT04417608

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

June 4, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2021

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

1.1 years

First QC Date

May 31, 2020

Last Update Submit

June 3, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (5)

  • Sensory block of upper limb

    45min post nerve block

  • Sensory block of upper limb

    24hour post nerve block

  • Motor block of upper limb

    45min post nerve block

  • Motor block of upper limb

    24hour post nerve block

  • Motor block of upper limb

    48hour post nerve block

Interventions

Ultrasound-guided infraclavicular brachial plexus block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who are scheduled for upper limb surgery

You may qualify if:

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

You may not qualify if:

  • Pre-existing neuropathy (ex: polyneuropathy)
  • History of allergy to xylocaine、ropivacaine、epinephrine
  • Emergent surgery
  • Coagulopathy
  • Patient who can not express themselves

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 31, 2020

First Posted

June 4, 2020

Study Start

June 4, 2020

Primary Completion

July 4, 2021

Study Completion

July 4, 2021

Last Updated

June 4, 2020

Record last verified: 2020-06