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Clinical Trials/NCT05544721
NCT05544721
Enrolling By Invitation
Phase 4

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

Mayo Clinic1 site in 1 country50 target enrollmentOctober 5, 2022

Overview

Phase
Phase 4
Intervention
Ropivacaine
Conditions
Thoracic Outlet Syndrome
Sponsor
Mayo Clinic
Enrollment
50
Locations
1
Primary Endpoint
Change in pain level
Status
Enrolling By Invitation
Last Updated
5 months ago

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.

Registry
clinicaltrials.gov
Start Date
October 5, 2022
End Date
August 1, 2027
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Houssam Farres, M.D.

Principal Investigator

Mayo Clinic

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.

Arms & Interventions

Paravertebral block pre procedure

Subjects will receive a preoperative paravertebral block only

Intervention: Ropivacaine

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

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)

Study Sites (1)

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