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

224 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Bilateral paravertebral block with 0.25% ropivacaine with 1:400,000 epinephrine for post-cardiac surgery pain?

Research suggests that paravertebral block, which involves injecting pain-relieving medication near the spine, can be an effective alternative to other pain control methods like epidurals for surgeries such as thoracotomy (chest surgery). However, studies specifically on cardiac surgery show mixed results, with some concerns about potential side effects and the need for further research to determine the best dosage and safety. ^{1 2 3 4 5}

Is the paravertebral block with ropivacaine safe for humans?

A study found that using high doses of ropivacaine in paravertebral blocks for cardiac surgery could lead to potentially toxic levels in the blood, which might cause mental state changes after surgery. One patient experienced local anesthetic toxicity, suggesting that lower doses should be used to ensure safety. ^{1 2 4 6 7}

How does the paravertebral block treatment for post-cardiac surgery pain differ from other treatments?

The paravertebral block treatment for post-cardiac surgery pain is unique because it uses a simple technique that avoids the potential complications associated with epidural catheters, and it involves the administration of ropivacaine with epinephrine directly near the spine to block pain signals, which can be more targeted than systemic pain relief methods. ^{1 2 3 4 5}

What is the purpose of this trial?

This study aims to evaluate the efficacy of bilateral, paravertebral blockade (intervention) against sham blocks (control) placed prior to sternotomy in improving quality of recovery following cardiac surgery. Primary outcome: The hypothesis is that bilateral single-shot PVB at the thoracic spinal segmental levels T3/4, compared with sham blocks, improve the Quality of Recovery-15 (QoR-15) score at 24 hours following cardiac surgery by a minimally clinically important difference of 8.0 or greater. Secondary outcomes: The hypothesis is that the intervention will reduce pain scores, opioid requirements, and related side effects; improve respiratory mechanics; and facilitate a better first night's rest/sleep in the first 24-48 hours compared to sham blocks.

Research Team

Terri Sun, M.D.

Principal Investigator

University of British Columbia

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. 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]

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

Local anaesthetic toxicity after bilateral thoracic paravertebral block in patients undergoing coronary artery bypass surgery. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

Bilateral Paravertebral Block versus Thoracic Epidural Analgesia for Pain Control Post-Cardiac Surgery: A Randomized Controlled Trial. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

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

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. India pubmed.ncbi.nlm.nih.gov

Continuous paravertebral infusion of ropivacaine with or without fentanyl for pain relief in unilateral multiple fractured ribs. [2021]