Intercostal Plane Block for Post Cardiac Surgery Pain

(EPOCH Trial)

Recruiting at 3 trial locations

Overseen By Ahmad Alli, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Unity Health Toronto

Must not be taking: Opioids, Illicit drugs

Disqualifiers: Redo sternotomy, Emergency procedures, Clinical instability, Weight < 50kg, Active infection, Pregnancy, Chronic opioid use, Allergies, Cognitive impairment, Investigational drug/device, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 72 hours

340 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to manage pain after heart surgery, aiming to reduce opioid use. Patients will receive an intercostal plane block, where the numbing medicine ropivacaine is delivered near the chest wall to ease pain. Researchers will compare this to a placebo to determine if it reduces opioid use after surgery. Suitable candidates are those who have undergone heart surgery involving a median sternotomy (through the breastbone). As an unphased trial, this study allows patients to contribute to innovative pain management research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using opioids or narcotics regularly, you may not be eligible to participate.

What prior data suggests that this method is safe for reducing opioid usage after cardiac surgery?

Research shows that using ropivacaine in the intercostal plane block is generally safe and well-tolerated for managing pain after surgeries like heart operations. Studies have found that this method can effectively reduce the need for opioids, which are strong painkillers with serious side effects.

In past cases, patients who received ropivacaine in similar ways experienced good pain relief with few side effects. While any medication can have some side effects, ropivacaine is considered safe for managing pain after surgery.

Additionally, the FDA has already approved ropivacaine for other uses, which adds confidence to its safety. This suggests that, for most people, the treatment should not cause significant problems, though individual responses can vary. Always consider discussing any concerns with the trial team or your healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the intermittent superficial parasternal intercostal plane block using 0.2% ropivacaine for post cardiac surgery pain because it offers a targeted approach to pain management. Unlike traditional systemic painkillers, which can affect the entire body, this method uses a local delivery system via ultrasound-guided catheter placement to directly block pain in the chest area. This localized technique not only aims to provide more effective pain relief right where it's needed but also minimizes the risk of systemic side effects, which are common with oral pain medications. Additionally, the use of 0.2% ropivacaine, an anesthetic, in this manner could potentially provide longer-lasting pain control with intermittent dosing.

What evidence suggests that this treatment might be an effective treatment for post cardiac surgery pain?

Research has shown that a specific type of pain relief, called a superficial parasternal intercostal plane block with ropivacaine, can help manage pain after heart surgery. Studies have found that this method reduces the need for opioids by providing better pain relief. Specifically, patients who received this block used less pain medication over 48 hours compared to those who did not. This technique targets nerves near the chest to block pain, helping patients feel more comfortable and recover more smoothly after surgery. These findings suggest it could be a promising option for reducing the need for strong painkillers after heart surgery. ^{1 2 3 4 5}

Who Is on the Research Team?

Ahmad Alli, MD

Principal Investigator

Unity Health Toronto

Are You a Good Fit for This Trial?

This trial is for adults having heart surgery through a cut down the middle of their chest (median sternotomy). It's not for those who've had this type of surgery before, are in unstable condition, weigh less than 50kg, are pregnant or nursing, use opioids long-term or have chronic pain disorders. People with allergies to certain anesthetics or unable to follow the study rules can't join either.

Inclusion Criteria

I am an adult scheduled for heart surgery through a chest bone cut.

Exclusion Criteria

I weigh less than 50kg.

You are allergic to certain types of anesthesia or any part of the study treatment.

I have had heart surgery either by reopening the chest or through less invasive methods.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intermittent superficial parasternal intercostal plane blocks with either 0.2% ropivacaine or 0.9% saline

72 hours

Daily monitoring for 3 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain assessment and opioid use

3 months

Regular follow-up visits

Post-operative Recovery

Assessment of quality of recovery using Quality of Recovery-15 Scale

Post-operative day 4-7

What Are the Treatments Tested in This Trial?

Interventions

• Intermittent Superficial Parasternal Intercostal Plane Block

Trial Overview The trial tests if using intermittent superficial parasternal intercostal plane blocks with ropivacaine reduces opioid need after cardiac surgery compared to placebo (saline). Participants will be randomly assigned to receive either the real block or a sham procedure and monitored for opioid use up to 72 hours post-surgery.

How Is the Trial Designed?

Group I: 0.2% ropivacaine Experimental Treatment 1 Intervention

Intermittent superficial parasternal intercostal plane block via ultrasound-guided catheter placement. Initial bolus dosing of 20 milliliter (mL) of 0.2% ropivacaine per side at the time of catheter placement, followed by intermittent boluses of 10 mL 0.2% ropivacaine per side.

Group II: 0.9% saline Placebo Group 1 Intervention

Intermitted superficial parasternal intercostal plane block via ultrasound-guided catheter placement. Initial bolus of 20 mL of 0.9% saline per side at the time of catheter placement, followed by intermitted boluses of 10 ml of 0.9% saline per side.

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials

572

Recruited

470,000+

Queen Elizabeth II Health Sciences Centre

Collaborator

Trials

26

Recruited

14,200+

Foothills Medical Centre

Collaborator

Trials

21

Recruited

20,200+

Published Research Related to This Trial

Patients who received bilateral deep parasternal intercostal plane (DPIP) blocks after cardiac surgery required 60% fewer opioids in the first 24 hours compared to those who did not receive the blocks, indicating significant analgesic efficacy.

The use of DPIP blocks was also associated with lower pain scores on postoperative days 0 and 1, and a potential reduction in the incidence of atrial fibrillation, suggesting additional benefits beyond pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep Parasternal Intercostal Plane Block for Postoperative Analgesia After Sternotomy for Cardiac Surgery-A Retrospective Cohort Study. Skojec, AJ., Christensen, JM., Yalamuri, SM., et al.[2023]

The deep parasternal intercostal plane block provides greater spread of analgesia compared to the superficial block, covering more parasternal interspaces, which could enhance pain management for surgeries like breast and cardiac procedures.

However, the deep block is closer to the internal mammary artery, raising safety concerns about potential arterial injury, suggesting it should be considered an advanced technique requiring careful application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Superficial versus deep parasternal intercostal plane blocks: cadaveric evaluation of injectate spread. Douglas, RN., Kattil, P., Lachman, N., et al.[2023]

The rhomboid intercostal and subserratus plane (RISS) block significantly reduced postoperative pain scores in patients after thoracotomy compared to standard intravenous analgesia, with lower pain ratings at all measured time intervals (P < 0.001).

Patients receiving the RISS block consumed less tramadol and reported higher satisfaction with pain management, while also showing less decline in lung function post-surgery, indicating improved recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of rhomboid intercostal and subserratus plane block under direct vision for postoperative analgesia in thoracic surgeries: a prospective, randomized controlled trial. Kozanhan, B., Semerkant, T., Esme, H., et al.[2022]

Both the superficial parasternal intercostal plane block (SPIP) and deep parasternal intercostal plane block (DPIP) provide effective postoperative pain management for patients undergoing median sternotomy, significantly reducing the need for opioids compared to traditional morphine use.

Patients receiving SPIP and DPIP experienced lower consumption of antiemetic medication (metoclopramide) compared to those on morphine, indicating a potential benefit in reducing side effects associated with opioid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Which ultrasound-guided parasternal intercostal nerve block for post-sternotomy pain? Results from a prospective observational study. Toscano, A., Capuano, P., Perrucci, C., et al.[2023]

In a study of 80 adult cardiac surgical patients, the use of pecto-intercostal fascial plane block (PIFB) with 0.25% bupivacaine resulted in significantly lower pain scores compared to placebo, indicating effective pain management post-surgery.

Although there was a trend towards reduced opioid consumption in the bupivacaine group, the difference was not statistically significant, suggesting that while PIFB is safe and may help with pain, its impact on opioid use needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Pecto-Intercostal Fascial Block for Postoperative Pain Management in Cardiac Surgery: A Prospective, Randomized, Placebo-Controlled Trial. Khera, T., Murugappan, KR., Leibowitz, A., et al.[2021]

Parasternal intercostal nerve blocks can effectively reduce opioid consumption and improve pain management in patients undergoing cardiac surgery, as supported by 10 randomized trials and observational studies.

Standardization of the technique for performing these blocks is crucial, as variations in methods may significantly affect clinical outcomes, highlighting the need for consistent protocols in Enhanced Recovery After Surgery programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parasternal Intercostal Nerve Blocks in Patients Undergoing Cardiac Surgery: Evidence Update and Technical Considerations. Schiavoni, L., Nenna, A., Cardetta, F., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06028126

Superficial Parasternal Intercostal Plane Block in Cardiac ... The primary outcome will be cumulative postoperative opioid use (measured as Milligram Morphine Equivalent (MME)) up to 72 hours following catheter insertion.

2. sciencedirect.com sciencedirect.com/science/article/pii/S095281802400059X

Efficacy of bilateral catheter superficial parasternal ... Bilateral catheter SPIP blocks using PIB with ropivacaine reduced opioid consumption over 48 h, concurrently delivering superior postoperative analgesia.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12324778/

Effectiveness of Pecto-Intercostal Fascia Plane Block in ... The pecto-intercostal fascia plane block (PIFB) is gaining recognition for its potential to reduce postoperative opioid use after cardiac ...

4. withpower.com withpower.com/trial/phase-emergence-delirium-8-2023-6a851

Intercostal Plane Block for Post Cardiac Surgery Pain ... Research suggests that parasternal intercostal nerve blocks, like the superficial parasternal intercostal plane block, can help reduce pain and the need for ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40728057/

Postoperative pain outcome following a superficial ... This study showed that implementation of a SPIP block might further improve postoperative pain management following cardiac surgery in ...