Paravertebral Block for Thoracic Outlet Syndrome

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy, CRPS, Brachial plexus disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a nerve block (an injection to numb a specific area) administered both before and after surgery for Thoracic Outlet Syndrome, compared to administration only before surgery. The trial focuses on ropivacaine, a medication that manages pain. It targets individuals scheduled for surgery to remove the first rib due to Thoracic Outlet Syndrome, a condition causing pain and numbness in the shoulder and arm. Participants will learn whether receiving the nerve block twice provides better pain relief than receiving it once. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What is the safety track record for Ropivacaine?

Research has shown that ropivacaine, used for certain types of pain relief, is generally safe. Studies indicate a low risk of major complications, with serious side effects being rare. As an approved local anesthetic, ropivacaine is usually well-tolerated. Most patients do not experience severe problems, making it a reliable choice for managing pain in procedures like first rib removals. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using paravertebral blocks with ropivacaine for thoracic outlet syndrome because this approach may offer better pain control and quicker recovery. Unlike standard treatments that often involve oral pain medications or more invasive surgeries, these blocks deliver the anesthetic directly to the nerves around the spine, potentially reducing systemic side effects and enhancing precision in pain relief. Additionally, administering the block both before and after surgery, as in one of the trial arms, could provide extended pain management, improving overall patient comfort and possibly speeding up the healing process.

What evidence suggests that this trial's treatments could be effective for thoracic outlet syndrome?

Research has shown that ropivacaine, when used in specific nerve blocks near the spine, effectively manages pain for individuals undergoing chest surgeries. After surgery, a continuous drip of ropivacaine significantly reduced pain both at rest and during activities like coughing. One study found that a single shot of ropivacaine provided longer-lasting pain relief for patients undergoing lung surgery. Compared to other pain relief methods, continuous ropivacaine infusions near the spine improved pain management after chest surgeries. This trial will compare two approaches: one group will receive a paravertebral block with ropivacaine both preoperatively and on postoperative day 1, while another group will receive a preoperative paravertebral block only. This evidence supports using ropivacaine in this way to manage pain after surgery, which is the focus of the study in question. ^{1 2 5 6 7}

Who Is on the Research Team?

Houssam Farres, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with Thoracic Outlet Syndrome who are scheduled for first rib resection surgery. It's not open to those who are pregnant, have had the same surgery before, suffer from complex regional pain syndrome (CRPS), brachial plexus disorders, or have a cervical rib.

Inclusion Criteria

I am scheduled for my first surgery to remove a rib due to Thoracic Outlet Syndrome.

Exclusion Criteria

I have a cervical rib.

I have a brachial plexus disorder.

I have been diagnosed with complex regional pain syndrome.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-operative Treatment

Participants receive a paravertebral block prior to the first rib resection procedure

1 day

1 visit (in-person)

Post-operative Treatment

Participants receive a paravertebral block on postoperative day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in pain level and quality of life post-surgery

2 weeks

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Ropivacaine

Trial Overview The study is testing the effectiveness of Ropivacaine as a paravertebral block administered before and after first rib resection surgery compared to receiving it only before the procedure.

How Is the Trial Designed?

Group I: Paravertebral block pre and post procedure Active Control 1 Intervention

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

Group II: Paravertebral block pre procedure Active Control 1 Intervention

Subjects will receive a preoperative paravertebral block only

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Bilateral thoracic paravertebral block significantly reduced pain scores and sedation levels compared to patient-controlled intravenous analgesia (PCIA) in patients after off-pump coronary artery bypass grafting (OPCABG), indicating its efficacy for postoperative pain management.

This technique also resulted in fewer cardiovascular complications, such as sinus tachycardia and hypertension, and led to shorter extubation and ICU stay times, demonstrating its safety and potential to improve recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Feasibility study of bilateral thoracic paravertebral block for postoperative analgesia in patients after off-pump coronary artery bypass grafting]. Sun, LX., Cong, L., Wang, MS., et al.[2014]

Ropivacaine, when used for thoracic paravertebral block in 20 female patients, showed a rapid absorption phase similar to intravenous administration, indicating effective delivery for pain management during surgery.

The addition of epinephrine to ropivacaine significantly delayed its absorption into the bloodstream and reduced peak plasma concentrations, which may enhance safety by minimizing potential toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arterial and venous pharmacokinetics of ropivacaine with and without epinephrine after thoracic paravertebral block. Karmakar, MK., Ho, AM., Law, BK., et al.[2022]

A continuous infusion of ropivacaine via a thoracic paravertebral block significantly reduced pain scores at rest and during coughing in postoperative patients compared to a control group, indicating improved pain management.

Patients receiving the ropivacaine infusion experienced fewer side effects, such as nausea and urinary retention, while maintaining safe plasma levels of the drug, suggesting a safer alternative to traditional epidural analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paravertebral block with ropivacaine 0.5% versus systemic analgesia for pain relief after thoracotomy. Marret, E., Bazelly, B., Taylor, G., et al.[2022]

Paravertebral block combined with nonsteroidal anti-inflammatory drugs is a safe and effective method for managing post-thoracotomy pain, with only 16% of patients requiring additional pain relief with meperidine.

Patients who underwent anterior thoracotomy experienced significantly less pain than those who had posterolateral thoracotomy, and bupivacaine provided slightly better pain control compared to ropivacaine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative analysis of analgesic quality in the postoperative of thoracotomy: paravertebral block with bupivacaine 0.5% vs ropivacaine 0.2%. Fibla, JJ., Molins, L., Mier, JM., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05544721

A Study of Paravertebral Block in Thoracic Outlet Syndrome It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

2. withpower.com withpower.com/trial/paravertebral-block-for-thoracic-outlet-syndrome-d8429

Paravertebral Block for Thoracic Outlet Syndrome A continuous infusion of ropivacaine via a thoracic paravertebral block significantly reduced pain scores at rest and during coughing in postoperative patients ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8443377/

Thoracic Paravertebral Nerve Block with Ropivacaine and ... A small volume of TPVB with ropivacaine and DEX by single injection produced longer analgesia in patients undergoing video-assisted thoracoscopic lobectomy.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/15919319/

Paravertebral block with ropivacaine 0.5% versus systemic ... Conclusions: Continuous paravertebral ropivacaine 0.5% infusion improves pain control after thoracic surgery using a multimodal analgesic approach.

5. academic.oup.com academic.oup.com/ejcts/article/33/3/430/359451

paravertebral block with bupivacaine 0.5% vs ropivacaine 0.2 ... Abstract. Objectives: Paravertebral block is an effective alternative to epidural analgesia in the management of post-thoracotomy pain, however, there are.

6. rapm.bmj.com rapm.bmj.com/content/early/2023/08/17/rapm-2023-104667

Local anesthetic dosing and toxicity of adult truncal catheters Adding sufentanil to ropivacaine in continuous thoracic paravertebral block fails to improve analgesia after video-assisted thoracic surgery ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1276640/

Use of general anesthetic only vs ... Our study showed that PVBs for first rib resections result in a significant decrease in postoperative pain but no significant decrease in opioid usage.