A Study of Paravertebral Block in Thoracic Outlet Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Pre-Operative and Post-Operative Paravertebral Block on Patients With Thoracic Outlet Syndrome.

Conditions
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Thoracic Outlet Syndrome

Intervention / Treatment
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* Drug: Ropivacaine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paravertebral block pre procedure<br>Subjects will receive a preoperative paravertebral block only | Drug: Ropivacaine<br>* 0.5% 3-4 mL per level, with levels T1 and T2 will be used as the block injectate<br>|
| Active Comparator: Paravertebral block pre and post procedure<br>Subjects will receive one paravertebral block, administered preoperatively and one paravertebral block, administered on postoperative day 1 | Drug: Ropivacaine<br>* 0.5% 3-4 mL per level, with levels T1 and T2 will be used as the block injectate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Time of discharge (approximately 1 day), day 1 post-op, day 3 post-op, day 7 post-op, and day 14 post-op | 
| Length of stay | Number of hours subjects are in the hospital following their surgical procedure | Approximately 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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First rib resection procedure