A Study of Paravertebral Block in Thoracic Outlet Syndrome

Phase 4

• Conditions: Thoracic Outlet Syndrome
• Interventions: Drug: Ropivacaine

• Registration Number: NCT05544721
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-14
• Study First Submitted QC: 2022-09-14
• Study First Posted: 2022-09-16
• Study Start: 2022-10-05
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paravertebral block pre procedure	Ropivacaine	Subjects will receive a preoperative paravertebral block only
Paravertebral block pre and post procedure	Ropivacaine	Subjects will receive one paravertebral block, administered preoperatively and one paravertebral block, administered on postoperative day 1

Primary Outcome Measures

Name	Time	Method
Change in pain level	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 Outcome Measures

Name	Time	Method
Length of stay	Approximately 1 day	Number of hours subjects are in the hospital following their surgical procedure
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	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

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States