Paravertebral Block for Post Cardiac Surgery Pain

Overseen By Terri Sun, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Must not be taking: Anticoagulants, Non-ASA antiplatelets

Disqualifiers: Chronic pain, Opioid use, Liver failure, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special pain relief method for individuals undergoing heart surgery. Researchers aim to determine if a pain block, known as a paravertebral block (a type of regional anesthesia), reduces pain more effectively than a sham block. They hope this method will result in less pain, reduced need for painkillers, and improved sleep after surgery. English-speaking adults scheduled for planned heart surgery involving a chest incision may qualify for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative pain management strategies that could enhance recovery experiences for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that patients on certain blood thinners or anti-platelet medications must stop them for a specific time before participating. It's best to discuss your current medications with the trial team.

What prior data suggests that this protocol is safe for cardiac surgery patients?

Research shows that ropivacaine in paravertebral blocks is generally safe and well-tolerated. Studies suggest that thoracic paravertebral blocks, like the one used in this trial, effectively relieve pain with fewer side effects than other pain management methods.

Ropivacaine, a local anesthetic, carries a low risk of serious side effects when used in this type of block. Most side effects, if they occur, are mild and may include temporary numbness or soreness at the injection site.

Adding epinephrine to ropivacaine can extend pain relief and reduce the chance of the anesthetic spreading to other areas. Overall, this combination aims to provide effective pain relief with a good safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the paravertebral block technique for post-cardiac surgery pain because it offers a targeted and potentially more effective approach than traditional pain relief methods like opioids. Unlike opioids, which can lead to dependency and have various side effects, this technique involves the administration of 0.25% ropivacaine with epinephrine directly into the paravertebral space, providing localized pain relief. This method could result in fewer complications and a quicker recovery, addressing a critical need for safer pain management options in cardiac surgery patients.

What evidence suggests that this paravertebral block is effective for post cardiac surgery pain?

In this trial, participants will receive either a bilateral paravertebral block (PVB) with 0.25% ropivacaine or a bilateral sham block with normal saline. Research has shown that a bilateral PVB with 0.25% ropivacaine effectively reduces pain after heart surgery. Studies have found that this method provides better pain relief than other options, such as thoracic epidurals. PVB is safe and reduces the need for opioids, which are strong painkillers with potential side effects. It also helps patients breathe easier and sleep better after surgery. Overall, PVB with ropivacaine offers a promising way to improve recovery after heart surgery. ^{1 6 7 8 9}

Who Is on the Research Team?

Terri Sun, M.D.

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

This trial is for adults over 19 years old scheduled for elective cardiac surgery who are English-speaking, at high risk (Euroscore II >=8%), and expected to need post-op ventilation for more than a day. It's not for those with chronic pain or opioid use, psychiatric disorders, severe organ failure, allergies to study meds, extreme weights, or certain blood conditions.

Inclusion Criteria

Your Euroscore II is more than 8%, indicating a high risk for the study.

I have had 3 or more major surgeries.

I require a procedure involving cooling and stopping my blood circulation.

Exclusion Criteria

You have a known blood clotting problem before surgery.

I have severe spine curvature or have had spine or chest surgery.

Your blood clotting tests are abnormal without taking any blood thinning medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Bilateral paravertebral blockade or sham block is administered prior to sternotomy during cardiac surgery

1 day

1 visit (in-person)

Immediate Post-operative Care

Patients are monitored in the CSICU, extubated within 4-6 hours, and receive pain management for the first 24-48 hours

2 days

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness, including QoR-15 scores at 24 hours, 48 hours, and 12 weeks post-surgery

12 weeks

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Bilateral paravertebral block with 0.25% ropivacaine with 1:400,000 epinephrine
• Bilateral sham block with normal saline

Trial Overview The study tests if a paravertebral block using ropivacaine before chest opening can improve recovery quality after heart surgery compared to sham blocks with saline. It looks at recovery scores after 24 hours and also examines pain levels, opioid needs, respiratory function, and sleep within the first two days.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

Bilateral, single level, paravertebral blockade with 0.25% ropivicaine

Group II: Control Group Placebo Group 1 Intervention

Bilateral, single level, subcutaneous sham block with normal saline

Bilateral paravertebral block with 0.25% ropivacaine with 1:400,000 epinephrine is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Paravertebral Block for:

• Pain management for cardiothoracic surgery
• Analgesia for thoracic surgery

Approved in United States as Paravertebral Block for:

• Pain management for cardiothoracic surgery
• Analgesia for thoracic surgery

Approved in Canada as Paravertebral Block for:

• Pain management for cardiothoracic surgery
• Analgesia for thoracic surgery

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Canadian Anesthesiologists' Society

Collaborator

Trials

19

Recruited

3,000+

Providence Health & Services

Collaborator

Trials

131

Recruited

827,000+

Published Research Related to This Trial

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]

Ultrasound-guided bilateral thoracic paravertebral block is a safe and effective method for managing pain after cardiac surgery, showing similar pain control to thoracic epidural block, but with some advantages.

Patients receiving paravertebral block had shorter ICU stays and lower rates of urinary retention and vomiting compared to those with epidural analgesia, indicating potential benefits in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral Paravertebral Block versus Thoracic Epidural Analgesia for Pain Control Post-Cardiac Surgery: A Randomized Controlled Trial. El Shora, HA., El Beleehy, AA., Abdelwahab, AA., et al.[2020]

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]

In a pilot study of 8 patients undergoing coronary artery bypass surgery, the use of bilateral thoracic paravertebral block (BTPB) with ropivacaine did not eliminate the need for supplemental opioids, indicating limited efficacy in pain management.

The study found that the doses of ropivacaine used were potentially toxic, leading to high plasma concentrations and one case of local anaesthetic toxicity, prompting the early termination of the study and a recommendation for lower doses in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local anaesthetic toxicity after bilateral thoracic paravertebral block in patients undergoing coronary artery bypass surgery. Ho, AM., Karmakar, MK., Ng, SK., et al.[2019]

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]

Continuous thoracic paravertebral block using ropivacaine with adrenaline provides effective analgesia for patients with multiple fractured ribs, with no signs of local anesthetic toxicity observed in the study of 30 adults.

The addition of fentanyl to the ropivacaine infusion allows for a lower concentration of ropivacaine without compromising pain relief or increasing side effects, suggesting a safer and effective pain management strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous paravertebral infusion of ropivacaine with or without fentanyl for pain relief in unilateral multiple fractured ribs. Mohta, M., Ophrii, EL., Sethi, AK., et al.[2021]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1053077025007487

Original Article The Effect of Thoracic Paravertebral Block ... To evaluate the effect of bilateral single-shot thoracic paravertebral block (PVB) on postoperative analgesia in patients undergoing coronary ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30114712/

Bilateral Paravertebral Block versus Thoracic Epidural ... This randomized parallel controlled trial demonstrates that ultrasound-guided paravertebral block is safe and effective method for relieving post-cardiac ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10600725/

Effectiveness of Surgeon-Performed Paravertebral Block ... Effectiveness of surgeon-performed paravertebral block analgesia for minimally invasive thoracic surgery: a randomized clinical trial.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06008821

Paravertebral Block for Improvement of Quality of Recovery ... This study aims to evaluate the efficacy of bilateral, paravertebral blockade (intervention) against sham blocks (control) placed prior to sternotomy in ...

5. cts.springeropen.com cts.springeropen.com/articles/10.1186/s43057-020-00027-y

Continuous paravertebral block by intraoperative direct ... Thoracic paravertebral block provides a comparable pain relief to epidural analgesia, with less side effects due to its unilateral effect.

6. withpower.com withpower.com/trial/paravertebral-block-for-post-cardiac-surgery-pain-cc379

Paravertebral Block for Post Cardiac Surgery Pain This study aims to evaluate the efficacy of bilateral, paravertebral blockade (intervention) against sham blocks (control) placed prior to sternotomy in ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S105307700600098X

Paravertebral Ropivacaine, 0.3%, and Bupivacaine, 0.25% ... Objective: This study was designed to determine whether ropivacaine plus fentanyl was as effective as bupivacaine plus fentanyl in a continuous thoracic ...

8. academic.oup.com academic.oup.com/icvts/article/18/5/626/670074

Analgesic efficacy and safety of thoracic paravertebral and ... We conclude that thoracic PVB may be as effective as thoracic epidural analgesia for post-thoracotomy pain relief and is also associated with fewer ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT01735851

Comparison of Bilateral Thoracic Paravertebral Block to ... Additional nurse administered boluses of 5-10mL of ropivacaine 0.2% via the paravetebral catheters will be permitted every 6 hourly to the side of maximal pain.