Back to resultsA Study of Paravertebral Block in Thoracic Outlet Syndrome
Primary Purpose
Thoracic Outlet Syndrome
Status
Enrolling by invitation
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine
Sponsored by
About this trial
This is an interventional supportive care trial for Thoracic Outlet Syndrome focused on measuring First rib resection procedure
Eligibility Criteria
Inclusion Criteria:
- All Thoracic Outlet Syndrome patients scheduled for first rib resection surgery.
Exclusion Criteria:
- Patients who are pregnant.
- Patients with prior first rib resection on side of presentation.
- Patients with complex regional pain syndrome (CRPS).
- Patients with brachial plexus disorder.
- Patients with cervical rib.
Sites / Locations
- Mayo Clinic in Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Paravertebral block pre procedure
Paravertebral block pre and post procedure
Arm Description
Subjects will receive a preoperative paravertebral block only
Subjects will receive one paravertebral block, administered preoperatively and one paravertebral block, administered on postoperative day 1
Outcomes
Primary Outcome Measures
Change in pain level
Measured using the pain visual analog scale (VAS). The VAS line will be 100 mm long with each end marked with "no pain" on the left, and "worst possible pain" on the right; participant identify their pain level by indicating a point on the line between each end and this point is measured from the "No pain" end, and the number of millimeters is reported as the pain score.
Secondary Outcome Measures
Change in quality of life
Measured using the Short Form (SF-36) Health Survey; The SF-36 Health Survey is a 36-item, participant-reported survey that measures patient health and disability. Possible scores range from 0 to 100, with 0 indicating maximum disability, and 100 indicating no disability
Length of stay
Number of hours subjects are in the hospital following their surgical procedure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05544721
Brief Title
A Study of Paravertebral Block in Thoracic Outlet Syndrome
Official Title
Pre-Operative and Post-Operative Paravertebral Block on Patients With Thoracic Outlet Syndrome.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 5, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This research is being done to evaluate the effects of receiving only a paravertebral block prior to first rib resection procedure versus receiving the block both pre and post procedure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Outlet Syndrome
Keywords
First rib resection procedure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Paravertebral block pre procedure
Arm Type
Active Comparator
Arm Description
Subjects will receive a preoperative paravertebral block only
Arm Title
Paravertebral block pre and post procedure
Arm Type
Active Comparator
Arm Description
Subjects will receive one paravertebral block, administered preoperatively and one paravertebral block, administered on postoperative day 1
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
0.5% 3-4 mL per level, with levels T1 and T2 will be used as the block injectate
Primary Outcome Measure Information:
Title
Change in pain level
Description
Measured using the pain visual analog scale (VAS). The VAS line will be 100 mm long with each end marked with "no pain" on the left, and "worst possible pain" on the right; participant identify their pain level by indicating a point on the line between each end and this point is measured from the "No pain" end, and the number of millimeters is reported as the pain score.
Time Frame
Time of discharge (approximately 1 day), day 1 post-op, day 3 post-op, day 7 post-op, and day 14 post-op
Secondary Outcome Measure Information:
Title
Change in quality of life
Description
Measured using the Short Form (SF-36) Health Survey; The SF-36 Health Survey is a 36-item, participant-reported survey that measures patient health and disability. Possible scores range from 0 to 100, with 0 indicating maximum disability, and 100 indicating no disability
Time Frame
Time of discharge (approximately 1 day), day 1 post-op, day 3 post-op, day 7 post-op, and day 14 post-op
Title
Length of stay
Description
Number of hours subjects are in the hospital following their surgical procedure
Time Frame
Approximately 1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- All Thoracic Outlet Syndrome patients scheduled for first rib resection surgery.
Exclusion Criteria:
Patients who are pregnant.
Patients with prior first rib resection on side of presentation.
Patients with complex regional pain syndrome (CRPS).
Patients with brachial plexus disorder.
Patients with cervical rib.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Houssam Farres, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Study of Paravertebral Block in Thoracic Outlet Syndrome
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