A Study of Paravertebral Block in Thoracic Outlet Syndrome

NCT05544721 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: 22-006685
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Outlet Syndrome

Keywords

First rib resection procedure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• Length of stay

  Approximately 1 day

Study Arms (2)

Paravertebral block pre procedure

ACTIVE COMPARATOR

Subjects will receive a preoperative paravertebral block only

Drug: Ropivacaine

Paravertebral block pre and post procedure

ACTIVE COMPARATOR

Subjects will receive one paravertebral block, administered preoperatively and one paravertebral block, administered on postoperative day 1

Drug: Ropivacaine

Interventions

Ropivacaine DRUG

0.5% 3-4 mL per level, with levels T1 and T2 will be used as the block injectate

Paravertebral block pre and post procedure; Paravertebral block pre procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- All Thoracic Outlet Syndrome patients scheduled for first rib resection surgery.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Thoracic Outlet Syndrome

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Nerve Compression Syndromes; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Houssam Farres, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 16, 2022
• Study Start: October 5, 2022
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)