Regional Anesthesia SuccessNCT04720079
Paravertebral Block With Brachial Plexus Block for Upper Arm Arteriovenous Fistula Surgery
A study testing Subcutaneous infiltration of intercostobrachial nerve and T2 paravertebral nerve block in people with Regional Anesthesia Success, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The primary goal of this quality improvement project is to find the optimal surgical conditions for patients undergoing upper arm arteriovenous graft surgery. Currently, there are two anesthetic techniques used in clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Regional Anesthesia Success
- What is being tested?
- Subcutaneous infiltration of intercostobrachial nerve and T2 paravertebral nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2020to 15 Feb 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (>18 years) undergoing upper limb arteriovenous fistula surgery at UNC Chapel Hill hospital
Who cannot join
- Contraindication to regional anesthesia
- Significant peripheral neuropathy or neurological disorder of the upper extremity
- Cognitive or psychiatric condition that will interfere with patient assessment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: The Effectiveness of Thoracic Paravertebral Block in Improving the Anesthetic Effects of Regional Anesthesia for Upper Extremity Arteriovenous Fistula Surgery
The primary goal of this quality improvement project is to find the optimal surgical conditions for patients undergoing upper arm arteriovenous graft surgery. Currently, there are two anesthetic techniques used in clinical practice. The goal is to standardize future practice and improve the care of patients postoperatively. The two techniques used in conjunction with a brachial plexus block are paravertebral nerve block and subcutaneous infiltration.
Read the detailed description
This study is designed to test the null hypothesis that paravertebral nerve block or subcutaneous infiltration provide similar operating conditions when combined with supraclavicular nerve block for upper arm arteriovenous fistula surgery. The results will help determine which approach to use and guide future research in this area.
- Conditions
- Regional Anesthesia Success
- Being tested
- Subcutaneous infiltration of intercostobrachial nerve, T2 paravertebral nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous infiltration of intercostobrachial nerveProcedure or surgery
Preoperative subcutaneous infiltration of intercostobrachial nerve with 10ml of 0.5% ropivacaine
T2 paravertebral nerve blockProcedure or surgery
Preoperative ultrasound guided T2 paravertebral nerve block with 10ml of 0.5% ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| Intercostobrachial nerve Infiltration | Active comparator | Preoperative infiltration of intercostobrachial nerve with 10ml of ropivacaine 0.5% Receives: Procedure: Subcutaneous infiltration of intercostobrachial nerve |
| Ultrasound guided T2 paravertebral block | Active comparator | Preoperative ultrasound guided T2 paravertebral nerve block with 10ml of ropivacaine 0.5% Receives: Procedure: T2 paravertebral nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Successful Regional Anesthesia
Success is considered a regional anesthetic without rescue analgesic medications (including surgeon administered local anesthetic) or conversion to general anesthesia
Measured: By end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start15 Nov 2020
- Primary completion15 Feb 2022
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional Anesthesia SuccessStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stuart A Grant, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720079
- Sponsor's protocol ID
- 20-2303
- Status last verified
- Nov 2021
- First submitted
- 14 Jan 2021
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Thoracic Paravertebral Block in Improving the Anesthetic Effects of Regional Anesthesia for Upper Extremity Arteriovenous Fistula Surgery
- ClinicalTrials.gov ID
- NCT04720079
- Acronym / sponsor ID
- 20-2303
- Conditions
- Regional Anesthesia Success
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 22 Jan 2021 (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.
The primary goal of this quality improvement project is to find the optimal surgical conditions for patients undergoing upper arm arteriovenous graft surgery. Currently, there are two anesthetic techniques used in clinical practice. The goal is to standardize future practice and improve the care of patients postoperatively. The two techniques used in conjunction with a brachial plexus block are paravertebral nerve block and subcutaneous infiltration.
Detailed description
This study is designed to test the null hypothesis that paravertebral nerve block or subcutaneous infiltration provide similar operating conditions when combined with supraclavicular nerve block for upper arm arteriovenous fistula surgery. The results will help determine which approach to use and guide future research in this area.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intercostobrachial nerve Infiltration | Active comparator | Procedure: Subcutaneous infiltration of intercostobrachial nervePreoperative infiltration of intercostobrachial nerve with 10ml of ropivacaine 0.5% |
| Ultrasound guided T2 paravertebral block | Active comparator | Procedure: T2 paravertebral nerve blockPreoperative ultrasound guided T2 paravertebral nerve block with 10ml of ropivacaine 0.5% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (>18 years) undergoing upper limb arteriovenous fistula surgery at UNC Chapel Hill hospital
Key exclusion criteria (3 listed)
- Contraindication to regional anesthesia
- Significant peripheral neuropathy or neurological disorder of the upper extremity
- Cognitive or psychiatric condition that will interfere with patient assessment
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 |
|---|---|---|
| Subcutaneous infiltration of intercostobrachial nervePreoperative subcutaneous infiltration of intercostobrachial nerve with 10ml of 0.5% ropivacaine | Procedure or surgery | Intercostobrachial nerve Infiltration |
| T2 paravertebral nerve blockPreoperative ultrasound guided T2 paravertebral nerve block with 10ml of 0.5% ropivacaine | Procedure or surgery | Ultrasound guided T2 paravertebral block |
Primary outcome
Number of Participants with Successful Regional Anesthesia
Time frame: By end of surgery
Success is considered a regional anesthetic without rescue analgesic medications (including surgeon administered local anesthetic) or conversion to general anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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.
Stuart A Grant principal investigator
UNC Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subcutaneous infiltration of intercostobrachial nerve and T2 paravertebral nerve block in people with Regional Anesthesia Success, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants with Successful Regional Anesthesia (time frame: By end of surgery). 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 13 May 2022.