Nerve Block for Post-Surgery Pain

Overseen By Alberto A Uribe

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Cognitive disorders, Diabetes, Pregnancy, others

Compensation: Varies

Number of Visits: 4

Duration: Surgery length

84 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a specific pain treatment, the Pecto-Intercostal Fascial Block, can reduce pain after heart surgery. Participants will receive either a nerve block with the local anesthetic ropivacaine or a placebo solution, in addition to standard pain management care. Doctors will assess pain and nausea levels post-surgery to determine if the nerve block offers additional benefits. Individuals undergoing their first heart surgery through the chest bone and without chronic pain issues may be suitable for this trial. As an unphased trial, it provides participants the chance to contribute to innovative pain management research.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, your medical history and medications taken within a month prior to surgery will be reviewed, so it's best to discuss this with the trial team.

What prior data suggests that this nerve block technique is safe for post-surgery pain management?

Research shows that the pecto-intercostal fascial block (PIFB) with ropivacaine is generally safe for managing post-surgical pain. Studies have found that this method effectively relieves pain with a low risk of serious side effects.

For instance, one study found that patients who received PIFB experienced better pain control and required fewer opioids, which are strong pain medications with potential side effects. Another study demonstrated that using PIFB in children undergoing heart surgery was safe and effective, with no major complications reported.

Overall, evidence suggests that PIFB with ropivacaine is well-tolerated and helps manage pain without causing significant problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for post-surgery pain rely on systemic medications like opioids or NSAIDs, which can have significant side effects. But the pecto-intercostal fascial block with ropivacaine offers a targeted approach, using a local anesthetic injected directly under ultrasound guidance. This method minimizes the need for systemic pain relievers, reducing potential side effects and enhancing pain control precisely where it's needed. Researchers are excited because this technique could lead to faster recovery times and a more comfortable post-operative experience for patients.

What evidence suggests that the Pecto-intercostal Fascial Block is effective for post-surgery pain?

Research has shown that the pecto-intercostal fascial block (PIFB) with ropivacaine, which participants in this trial may receive, effectively reduces post-surgical pain. Studies have found that it decreases the need for opioids, strong painkillers, and helps patients recover faster. Patients who received this type of block often reported better pain relief after surgeries, especially those involving the chest. This technique numbs specific nerves with ropivacaine, a local anesthetic, aiming to provide longer-lasting pain relief without heavily relying on medications like opioids. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals undergoing open heart surgery, who can have their medical history and medication use reviewed. They must be able to receive a nerve block in addition to standard pain control methods. There's no information on who cannot participate provided here.

Inclusion Criteria

Able to provide a signed written informed consent

Able to speak, read, and write in English

My health is classified between ASA I and IV.

Exclusion Criteria

I don't have infections, bleeding disorders, chest wall deformity, or allergies to local anesthetics or dexamethasone.

BMI ≥ 40 kg/m2

I have diabetes with nerve pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a bilateral nerve block with ropivacaine or saline during open-heart surgery

Surgery length

1 visit (in-person)

Postoperative Monitoring

Pain, nausea, and vomiting scores are assessed at 12, 24, and 48 hours after surgery

48 hours

Follow-up

Participants are monitored for pain-DETECT scores at 30, 60, and 90 days after surgery

90 days

3 follow-up calls

What Are the Treatments Tested in This Trial?

Interventions

• Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine
• Pecto-intercostal Fascial Block with normal saline

Trial Overview

The study tests if adding a bilateral nerve block with ropivacaine (a local anesthetic) improves pain management after open heart surgery compared to using saline solution, alongside regular pain relief measures.

How Is the Trial Designed?

Group I: Pecto-intercostal fascial block Active Control 1 Intervention

Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine injected to each side under ultrasound visualization.

Group II: Placebo Placebo Group 1 Intervention

Pecto-intercostal Fascial Block with 20ml of normal saline injected to each side under ultrasound visualization.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

The modified Pecs II block and pecto-intercostal fascial block (PIFB) were successfully performed in a parturient undergoing breast surgery, demonstrating their safety and effectiveness as regional anesthesia alternatives to general anesthesia.

These regional anesthesia techniques can reduce risks for both the patient and fetus during non-obstetric surgeries, making them valuable options for parturients who prefer to avoid general anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thoracic interfascial nerve block for breast surgery in a pregnant woman: a case report. Hong, B., Yoon, SH., Youn, AM., et al.[2019]

In a study involving 10 patients undergoing cardiac surgery, the combination of pecto-intercostal fascial block (PIFB) and rectus sheath block (RSB) using 70 mL of 0.3% ropivacaine was found to be safe, with no patients reaching toxic levels of the drug (above 4.3 µg/mL).

The peak concentration of ropivacaine was observed between 10 and 30 minutes after administration, and there were no signs of systemic toxicity during the perioperative period, indicating that this analgesic protocol is effective and safe for managing pain in cardiac surgery patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Total Ropivacaine Concentration in Blood after Bilateral Pecto-Intercostal Fascial Block Combined with Rectus Sheath Block in Cardiac Surgery Patients. Wang, L., Jiang, B., Shi, Y., et al.[2023]

The study demonstrated that ultrasound-guided pecto-intercostal fascial (PIF) blocks can effectively stain ventral cutaneous branches of intercostal nerves in canine cadavers, indicating that the technique can reach targeted nerve areas.

However, both low and high volumes of injectate did not provide adequate spread for effective analgesia to the sternum, suggesting that further in vivo studies are needed to optimize this regional anesthetic technique for veterinary use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of ultrasound-guided pecto-intercostal block in canine cadavers. Escalante, GC., Ferreira, TH., Hershberger-Braker, KL., et al.[2023]

Combining pecto-intercostal fascial block (PIFB) with rectus sheath block (RSB) significantly reduced intravenous opioid consumption within the first 24 and 48 hours after cardiac surgery, indicating improved pain management.

In a study of 54 patients, those receiving the combined treatment used 2.33 mg of opioids in the first 24 hours compared to 3.81 mg in the PIFB-only group, demonstrating the efficacy of the combination without affecting other recovery metrics like pain scores or hospital stay.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of pecto-intercostal fascial block combined with rectus sheath block for postoperative pain management after cardiac surgery: a randomized controlled trial. Wang, L., Jiang, L., Jiang, B., et al.[2023]

In a study of 108 patients undergoing open cardiac surgery, those who received bilateral Pecto-intercostal Fascial Block (PIFB) experienced significantly less postoperative pain and required less pain medication compared to those who did not receive the block.

The PIFB group also had faster recovery times, including shorter ICU stays and overall hospital stays, along with lower levels of insulin and inflammatory markers three days post-surgery, indicating improved recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of bilateral Pecto-intercostal Fascial Block for perioperative pain management in patients undergoing open cardiac surgery: a prospective randomized study. Zhang, Y., Gong, H., Zhan, B., et al.[2022]

The thoracic epidural is the standard method for managing pain in patients with chest injuries, but it can sometimes fail or provide inconsistent relief.

In a case study, the pectointercostal fascial plane block (PIFB) was successfully used to manage sternal pain in a patient with thoracic polytrauma after a patchy epidural block, suggesting PIFB could be a valuable alternative for pain control in such cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pectointercostal fascial plane block for rescue pain management of traumatic sternal fracture following inadequate thoracic epidural block: a case report. Hsu, M., Kinthala, S., Huang, J., et al.[2022]

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]

Citations

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pmc.ncbi.nlm.nih.gov

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sciencedirect.com

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Pectoral-Intercostal Fascial Plane Block Study (PIFB)

However, recently a regional anesthesia technique called the pecto-intercostal fascial block (PIFB) was found to be associated with improved pain relief for ...

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Effects of continuous pecto-intercostal fascial block for...

Continuous PIFB can provide satisfactory postoperative analgesia while reducing perioperative opioid consumption, diminishing the risk of postoperative ...

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ochsnerjournal.org

ochsnerjournal.org/content/early/2024/12/26/toj.24.0052

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Conclusion: The TTMPB and the PIFB were similarly effective in treating acute poststernotomy pain in our patient population. Keywords: Cardiac ...

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bmcanesthesiol.biomedcentral.com

bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-023-02044-w

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Secondary outcomes included opioid consumption within 48 h, postoperative pain scores, time to extubation, and length of stay in the hospital.

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jcardcritcare.org

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Assessment of Pain Control using Ultrasound-guided ...

Ultrasound-guided bilateral PIFB represents a safe and effective modality for the management of acute post-operative pain in pediatric patients ...