Intercostal Plane Block for Post Cardiac Surgery Pain

(EPOCH Trial)

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

310 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. However, if you are using opioids or narcotics regularly, you may not be eligible to participate.

What data supports the effectiveness of the treatment Intermittent Superficial Parasternal Intercostal Plane Block, Naropin 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 opioids after cardiac surgery. However, the results vary due to differences in how the procedure is done, and more standardized studies are needed to confirm these benefits. ^{1 2 3 4 5}

Is the intercostal plane block safe for humans?

The intercostal plane block, used for pain management after cardiac surgery, has been shown to reduce the need for opioids and their side effects, suggesting it is generally safe. However, differences in how the procedure is done can affect outcomes, so standardizing the technique is important for safety. ^{1 2 3 4 5}

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

The intercostal plane block treatment is unique because it involves injecting a local anesthetic into specific intercostal spaces under ultrasound guidance to provide pain relief after cardiac surgery. This method aims to reduce the need for opioids and their side effects, offering a potentially more favorable pain management option compared to traditional systemic pain medications. ^{1 2 3 4 6}

What is the purpose of this trial?

The goal of this clinical trial is to assess whether the use of intermittent superficial parasternal intercostal plane blocks reduces opioid usage in patients undergoing cardiac surgery with median sternotomy. Participants randomized to the intervention group will receive the blocks with 0.2% ropivacaine administered via catheters placed in the superficial parasternal intercostal plane bilaterally under ultrasound guidance. Researchers will compare this group with a control group given 0.9% saline through similarly placed catheters. The primary outcome will be cumulative postoperative opioid use (measured as Milligram Morphine Equivalent (MME)) up to 72 hours following catheter insertion.

Research Team

Ahmad Alli, MD

Principal Investigator

Unity Health Toronto

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

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

Parasternal Intercostal Nerve Blocks in Patients Undergoing Cardiac Surgery: Evidence Update and Technical Considerations. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Superficial versus deep parasternal intercostal plane blocks: cadaveric evaluation of injectate spread. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Which ultrasound-guided parasternal intercostal nerve block for post-sternotomy pain? Results from a prospective observational study. [2023]

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

Deep Parasternal Intercostal Plane Block for Postoperative Analgesia After Sternotomy for Cardiac Surgery-A Retrospective Cohort Study. [2023]

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

Ultrasound-Guided Pecto-Intercostal Fascial Block for Postoperative Pain Management in Cardiac Surgery: A Prospective, Randomized, Placebo-Controlled Trial. [2021]

6. Germany 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. [2022]