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

50 Participants Needed

Trial Summary

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 data supports the effectiveness of the drug Ropivacaine, Naropin for treating Thoracic Outlet Syndrome?

Research shows that Ropivacaine, used in paravertebral blocks, is effective in reducing pain after thoracic surgeries, suggesting it may help with pain management in Thoracic Outlet Syndrome as well. ^{1 2 3 4 5}

Is the paravertebral block using ropivacaine generally safe for humans?

Ropivacaine is generally considered safe for use in paravertebral blocks, with studies showing a low risk of major complications, such as local anesthetic systemic toxicity, occurring in about 1 in 2390 cases. However, there have been rare reports of central nervous system toxicity when used in other types of nerve blocks. ^{1 6 7 8 9}

How does the paravertebral block treatment differ from other treatments for thoracic outlet syndrome?

The paravertebral block treatment is unique because it involves injecting a local anesthetic into the paravertebral space, which can block nerves at multiple levels on one side of the body. This method is different from systemic pain relief options and can provide targeted pain control, potentially reducing the need for opioids and their associated side effects. ^{2 3 10 11 12}

What is the purpose of this trial?

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.

Research Team

Houssam Farres, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. China pubmed.ncbi.nlm.nih.gov

[Application of thoracic paravertebral nerve block in video-assisted thoracosopic surgery: a randomized controlled trial]. [2020]

2. Japan pubmed.ncbi.nlm.nih.gov

A single paravertebral injection via a needle vs. a catheter for the spreading to multiple intercostal levels: a randomized controlled trial. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Paravertebral block with ropivacaine 0.5% versus systemic analgesia for pain relief after thoracotomy. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of the Paravertebral Block on Chronic Postsurgical Pain After Thoracic Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2023]

5. China pubmed.ncbi.nlm.nih.gov

[Feasibility study of bilateral thoracic paravertebral block for postoperative analgesia in patients after off-pump coronary artery bypass grafting]. [2014]

6. United States pubmed.ncbi.nlm.nih.gov

Arterial and venous pharmacokinetics of ropivacaine with and without epinephrine after thoracic paravertebral block. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Thoracic Paravertebral Nerve Blocks in Pediatric Patients: Safety and Clinical Experience. [2018]

8. Spain pubmed.ncbi.nlm.nih.gov

[Convulsions induced by ropivacaine after brachial plexus block]. [2018]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of Dexmedetomidine Versus Nalbuphine as an Adjuvant on Paravertebral Block to Manage Postoperative Pain After Mastectomies. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Transient C5 Sensory and Motor Blockade After a Unilateral T4 Paravertebral Block: A Case Report. [2022]

11. Germany 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%. [2022]

12. Brazil pubmed.ncbi.nlm.nih.gov

[Addition of dexmedetomidine to bupivacaine in ultrasonography-guided paravertebral blockade potentiates postoperative pain relief among patients undergoing thoracotomy]. [2022]