Looking for Minimum Dose to Induce Sympathectomy in Infraclavicular Brachial Plexus Block

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.

Study Overview

• Status: Unknown
• Conditions: Finding the Minimum Dose to Induce Sympathectomy in Infraclavicular
• Intervention / Treatment: Procedure: Infraclavicular brachial plexus block

• Study Type: Observational
• Enrollment (Anticipated): 66

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who are scheduled for upper limb surgery

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Taipei Medical University WanFang Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 4, 2020
• Primary Completion (Anticipated): July 4, 2021
• Study Completion (Anticipated): July 4, 2021

Study Registration Dates

• First Submitted: May 31, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 3, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: N202003147

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No