ClinicalTrials.gg
Enrolling by invitationNCT05544721Updated Nov 14, 2025

A Study of Paravertebral Block in Thoracic Outlet Syndrome

A Phase 4 interventional study of Ropivacaine in Thoracic Outlet Syndrome, sponsored by Mayo Clinic. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-14.

Sponsored by Mayo Clinic · Phase 4, Interventional, and Supportive care

Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Thoracic Outlet Syndrome

Keywords

  • First rib resection procedure
03

In context

Thoracic Outlet Syndrome

33 studies on the registry are indexed under Thoracic Outlet Syndrome; 11 are open to participants now.

This study's planned enrollment of 50 is close to the median of 50 across 17 interventional studies indexed under Thoracic Outlet Syndrome.

Browse Thoracic Outlet Syndrome studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.

Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    Paravertebral block pre procedure

    Subjects will receive a preoperative paravertebral block only

    Drug: Ropivacaine

  • Active comparator
    Paravertebral block pre and post procedure

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

    Drug: Ropivacaine

Interventions

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

06

What researchers measure

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 frame: 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

  1. 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 frame: Time of discharge (approximately 1 day), day 1 post-op, day 3 post-op, day 7 post-op, and day 14 post-op

  2. Length of stay

    Number of hours subjects are in the hospital following their surgical procedure

    Time frame: Approximately 1 day

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2022 (actual). Primary completion is estimated for Aug 2027, 58 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 14, 2022
First posted
Sep 16, 2022
StartActual
Oct 5, 2022
Primary completionEst.
Aug 2027
CompletionEst.
Aug 2027
Last update
Nov 14, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05544721
Lead sponsor
Mayo Clinic
Responsible party
Houssam Farres, M.D. (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Sep 16, 2022
Start date
Oct 5, 2022
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Nov 14, 2025

Study contacts

Houssam Farres, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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Studies of the drug tested here: Ropivacaine

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