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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate if the use of a bilateral nerve block with a local anesthetic (ropivacaine), as part of a standard of care pain control regimen (called multimodal analgesia \[MMA\]), has a favorable effect on our institutional MMA pain regimen. Subjects will go through the following study procedures: review of medical history and medications subjects have taken within a month prior to surgery. Subjects will be randomly assigned to one of the two study groups (1:1) to receive either, an ultrasound-guided bilateral nerve block (called "Pecto-Intercostal Fascial Block \[PIFB\]") with ropivacaine or saline 0.9 solution, in addition to our institutional MMA regimen. A baseline line pain and nausea scores will be recorded before surgery. The block will be performed right after general anesthesia induction. The details about the surgery will be collected. Pain assessments, nausea and vomiting scores will be registered at 12, 24 and 48 hours after surgery as well. Lastly, a follow up phone call will be made by the research team to conduct a pain-detect questionnaire at 30, 60 and 90 days after surgery.

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 data supports the effectiveness of the treatment Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine for post-surgery pain?

Research shows that the Pecto-intercostal Fascial Block (PIFB) can help manage pain after cardiac surgery by reducing the need for opioids (strong painkillers) and lowering pain scores. This suggests it might also be effective for managing post-surgery pain in other types of surgeries. ^{1 2 3 4 5}

Is the Pecto-intercostal Fascial Block safe for humans?

The safety of the Pecto-intercostal Fascial Block, especially when using a large volume of ropivacaine, is uncertain according to research on cardiac surgery patients. ^{1 2 4 5 6}

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

The nerve block treatment, specifically the pecto-intercostal fascial block (PIFB), is unique because it targets the anterior branches of intercostal nerves to manage pain, particularly in cardiac surgery patients. Unlike traditional pain management methods, PIFB is administered using ultrasound guidance to provide targeted pain relief, potentially reducing the need for opioids and minimizing side effects. ^{1 2 3 5 7}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

References

1. 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]

2. United States 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. [2023]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Thoracic interfascial nerve block for breast surgery in a pregnant woman: a case report. [2019]

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

Evaluation of ultrasound-guided pecto-intercostal block in canine cadavers. [2023]

5. England 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. [2022]

6. England 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. [2023]

7. England 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. [2022]