A Study of Paravertebral Block in Thoracic Outlet Syndrome

Thoracic Outlet Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05544721
• Other study ID #: 22-006685
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: October 5, 2022
• Est. completion date: August 2024

Study information

• Verified date: November 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Syndrome
• Thoracic Outlet Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Length of stay	Number of hours subjects are in the hospital following their surgical procedure	Approximately 1 day

External Links

•   Mayo Clinic Clinical Trials