Finding the Minimum Dose to Induce Sympathectomy in InfraclavicularNCT04417608
Looking for Minimum Dose to Induce Sympathectomy in Infraclavicular Brachial Plexus Block
An observational study of Finding the Minimum Dose to Induce Sympathectomy in Infraclavicular, run by Taipei Medical University WanFang Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Finding the Minimum Dose to Induce Sympathectomy in Infraclavicular
- What is being tested?
- Infraclavicular brachial plexus block
- Type of treatment
- Surgery or procedure
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 4 Jun 2020to 4 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are scheduled for upper limb surgery
Who may be able to join
- Age between 20-80 y/o, BW: 40-90 kilograms，ASA class I-III，No pre-existing neuropathy，Scheduled for upper limb surgery.
Who cannot join
- Pre-existing neuropathy (ex: polyneuropathy)
- History of allergy to xylocaine、ropivacaine、epinephrine
- Emergent surgery
- Coagulopathy
- Patient who can not express themselves
About this study
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.
- Being tested
- Infraclavicular brachial plexus block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infraclavicular brachial plexus blockProcedure or surgery
Ultrasound-guided infraclavicular brachial plexus block
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of diameter of basilic vein and brachial artery
Use ultrasound to measure the difference of diameter at different time point.
Measured: 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.
Measured: 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.
Measured: Change from baseline diameter(pre-nerve block) at 48hour
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 48hour post nerve block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start4 Jun 2020 (estimated)
- Primary completion4 Jul 2021 (estimated)
- Study completion4 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Finding the Minimum Dose to Induce Sympathectomy in InfraclavicularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, anchihhsu, Taipei Medical University WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417608
- Sponsor's protocol ID
- N202003147
- Status last verified
- Jun 2020
- First submitted
- 31 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Looking for Minimum Dose to Induce Sympathectomy in Infraclavicular Brachial Plexus Block
- ClinicalTrials.gov ID
- NCT04417608
- Acronym / sponsor ID
- N202003147
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 4 Jun 2020 (estimated)
- Primary completion
- 4 Jul 2021 (estimated)
- Study completion
- 4 Jul 2021 (estimated)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are scheduled for upper limb surgery
Key inclusion criteria (1 listed)
- Age between 20-80 y/o, BW: 40-90 kilograms，ASA class I-III，No pre-existing neuropathy，Scheduled for upper limb surgery.
Key exclusion criteria (5 listed)
- Pre-existing neuropathy (ex: polyneuropathy)
- History of allergy to xylocaine、ropivacaine、epinephrine
- Emergent surgery
- Coagulopathy
- Patient who can not express themselves
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infraclavicular brachial plexus blockUltrasound-guided infraclavicular brachial plexus block | Procedure or surgery | – |
Primary outcome
Change of diameter of basilic vein and brachial artery
Time frame: Change from baseline diameter(pre-nerve block) at 45min
Use ultrasound to measure the difference of diameter at different time point.
Change of diameter of basilic vein and brachial artery
Time frame: Change from baseline diameter(pre-nerve block) at 24hour
Use ultrasound to measure the difference of diameter at different time point.
Change of diameter of basilic vein and brachial artery
Time frame: Change from baseline diameter(pre-nerve block) at 48hour
Use ultrasound to measure the difference of diameter at different time point.
5 secondary outcomes
Sensory block of upper limb
Time frame: 45min post nerve block
Sensory block of upper limb
Time frame: 24hour post nerve block
Motor block of upper limb
Time frame: 45min post nerve block
Motor block of upper limb
Time frame: 24hour post nerve block
Motor block of upper limb
Time frame: 48hour post nerve block
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Finding the Minimum Dose to Induce Sympathectomy in Infraclavicular, run by Taipei Medical University WanFang Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of diameter of basilic vein and brachial artery (time frame: Change from baseline diameter(pre-nerve block) at 45min). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.