Pre-Operative and Post-Operative Paravertebral Block on Patients With Thoracic Outlet Syndrome.
Trial Snapshot
- Phase
- Phase 4
- Status
- Enrolling By Invitation
- Sponsor
- Mayo Clinic
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in pain level
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Paravertebral block pre procedure
Subjects will receive a preoperative paravertebral block only
Intervention: Ropivacaine (Drug)
Paravertebral block pre and post procedure
Subjects will receive one paravertebral block, administered preoperatively and one paravertebral block, administered on postoperative day 1
Intervention: Ropivacaine (Drug)
Outcomes
Primary Outcomes
Change in pain level
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
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 Outcomes
- Length of stay(Approximately 1 day)
- Change in quality of life(Time of discharge (approximately 1 day), day 1 post-op, day 3 post-op, day 7 post-op, and day 14 post-op)
Investigators
Houssam Farres, M.D.
Principal Investigator
Mayo Clinic