A Study of Paravertebral Block in Thoracic Outlet Syndrome

Sponsor

Mayo Clinic (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05544721

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thoracic Outlet Syndrome	Drug: Ropivacaine	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Paravertebral block pre procedure Subjects will receive a preoperative paravertebral block only	Drug: Ropivacaine 0.5% 3-4 mL per level, with levels T1 and T2 will be used as the block injectate
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 0.5% 3-4 mL per level, with levels T1 and T2 will be used as the block injectate

Arm

Intervention/Treatment

Active Comparator: Paravertebral block pre procedure

Subjects will receive a preoperative paravertebral block only

Drug: Ropivacaine

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

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

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

Outcome Measures

Primary Outcome Measures

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

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
Length of stay [Approximately 1 day]
Number of hours subjects are in the hospital following their surgical procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Florida	Jacksonville	Florida	United States	32224

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Houssam Farres, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Houssam Farres, M.D., Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT05544721

Other Study ID Numbers:

22-006685

First Posted:

Sep 16, 2022

Last Update Posted:

Sep 16, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Houssam Farres, M.D., Principal Investigator, Mayo Clinic

First rib resection procedure

Additional relevant MeSH terms:

Thoracic Outlet Syndrome

Syndrome

Ropivacaine

Study Results

No Results Posted as of Sep 16, 2022