Erector Spinae vs Intercostal Nerve Blocks for Pain in Thoracic Surgery

Overseen By Eduard Shaykhinurov, MS

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: George Washington University

Disqualifiers: Allergy to anesthetics, Bilateral surgery, Emergent surgery

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

Trial Summary

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Erector Spinae Block with Bupivacaine (Marcaine®) for pain in thoracic surgery?

Research shows that the erector spinae plane block (ESPB) can effectively reduce pain after surgeries, such as spinal cord stimulation implants and breast surgeries, by providing pain relief across multiple areas of the body. This suggests that ESPB, when used with bupivacaine, may also help manage pain in thoracic surgeries. ^{1 2 3 4 5}

Is the erector spinae block generally safe for use in humans?

Erector spinae plane blocks are considered to have a favorable safety profile, but there is a possibility of systemic toxicity if the anesthetic spreads to other areas. Safety data suggest that careful dosing is important to minimize risks. ^{2 3 4 6 7}

How does the erector spinae block with bupivacaine differ from other treatments for pain in thoracic surgery?

The erector spinae block with bupivacaine is unique because it provides pain relief by blocking multiple nerve pathways in the back, offering both somatic (body) and visceral (organ) pain control. It is easier to perform and has fewer risks compared to traditional methods like thoracic epidurals, making it particularly useful for managing pain in both adults and children after thoracic surgery. ^{2 3 4 8 9}

What is the purpose of this trial?

This clinical trial compares efficacy in postoperative pain management in thoracic surgery between erector spinae block versus liposomal bupivacaine injections.

Eligibility Criteria

This trial is for individuals undergoing thoracic surgery, specifically video-assisted pulmonary resection, pleurodesis or decortication. It's not suitable for those who may have conditions that exclude them from the study as per the detailed criteria.

Inclusion Criteria

I have had surgery for lung issues using a camera.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Preoperative

Participants receive either an erector spinae block or an intercostal nerve block before surgery

1 day

Postoperative

Participants are monitored for pain management efficacy using morphine equivalent assessment and pain scores

72 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Erector Spinae Block with Bupivacaine (Marcaine®)
• Intercostal Nerve Block

Trial Overview The trial is testing two types of pain management: Erector Spinae (ESP) Block with Bupivacaine and Intercostal nerve block using liposomal bupivacaine to see which one better reduces postoperative pain in thoracic surgery patients.

Participant Groups

Group I: Preoperative Erector Spinae Block (ESB)(Bupivacaine)(Marcaine®) Active Control 2 Interventions

Group II: Intraoperative Intercostal Nerve Block (INB)(Liposomal Bupivacaine)(Exparel®) Active Control 2 Interventions

Who Is Running the Clinical Trial?

George Washington University

Lead Sponsor

Trials

263

Recruited

476,000+

Findings from Research

In a meta-analysis of four randomized controlled trials involving 203 patients, the erector spinae plane block (ESPB) significantly reduced pain scores at 48 hours post-thoracoscopic surgery compared to the intercostal nerve block (ICNB).

However, ESPB did not show a significant difference in pain scores at 24 hours, 4 to 6 hours, or 12 hours post-surgery, indicating that while it may be effective for longer-term pain relief, its immediate analgesic effects are comparable to ICNB.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic comparison of erector spinae plane block with intercostal nerve block for thoracoscopic surgery: A meta-analysis of randomized controlled trials. Ma, G., Gou, J., Chen, L., et al.[2023]

The erector spinae plane block (ESPB) using liposomal bupivacaine effectively reduced postoperative pain in 18 patients undergoing spinal cord stimulation implant, leading to low pain scores.

Patients receiving the ESPB experienced decreased opioid consumption after surgery, indicating a potential for improved pain management and reduced reliance on opioids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing post-operative analgesia following spinal cord stimulation implant: a comprehensive evaluation of the effectiveness of erector spinae plane block utilizing liposomal bupivacaine. Sagir, A., Murphy, M., Teames, R., et al.[2023]

Ultrasound-guided erector spinae plane block (ESPB) significantly reduces acute post-surgical pain and the need for additional pain relief in patients undergoing video-assisted thoracoscopic lobectomy, as evidenced by lower pain scores and reduced use of patient-controlled intravenous analgesia (PCIA) in the ESPB group (n=48) compared to the general anesthesia group (n=46).

While ESPB does not decrease the overall incidence of chronic post-surgical pain, it does lessen the severity of chronic pain and improves patient satisfaction, with fewer adverse effects such as postoperative nausea and vomiting compared to general anesthesia alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of ultrasound-guided erector spinae plane block on postoperative acute pain and chronic post-surgical pain in patients underwent video-assisted thoracoscopic lobectomy: a prospective randomized, controlled trial. Zhang, J., Liu, TX., Wang, WX., et al.[2023]

In a study of 15 patients undergoing thoracic surgery, the use of erector spinae plane blocks with ropivacaine showed a mean peak concentration (Cmax) of 2.5 mg/L, with some patients reaching potentially toxic levels, although no severe neurological symptoms were reported.

To minimize the risk of local anesthetic systemic toxicity, it is recommended to use a weight-based dosing approach, suggesting a maximum dose of 2.5 mg/kg based on ideal body weight, and reducing the initial dose to 75 mg could lower the risk of toxicity to less than 1%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population pharmacokinetic and safety analysis of ropivacaine used for erector spinae plane blocks. Schwenk, ES., Lam, E., Abulfathi, AA., et al.[2023]

References

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

Low thoracic erector spinae plane block for perioperative analgesia in lumbosacral spine surgery: a case series. [2019]

2. India pubmed.ncbi.nlm.nih.gov

Initial experience of erector spinae plane block in patients undergoing breast surgery: A case series. [2020]

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

Analgesic comparison of erector spinae plane block with intercostal nerve block for thoracoscopic surgery: A meta-analysis of randomized controlled trials. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Enhancing post-operative analgesia following spinal cord stimulation implant: a comprehensive evaluation of the effectiveness of erector spinae plane block utilizing liposomal bupivacaine. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Effects of ultrasound-guided erector spinae plane block on postoperative acute pain and chronic post-surgical pain in patients underwent video-assisted thoracoscopic lobectomy: a prospective randomized, controlled trial. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Population pharmacokinetic and safety analysis of ropivacaine used for erector spinae plane blocks. [2023]

7. Italy pubmed.ncbi.nlm.nih.gov

Efficacy of erector spinae nerve block for pain control after lumbar spinal surgeries: a systematic review and meta-analysis. [2023]

8. Spain pubmed.ncbi.nlm.nih.gov

Erector spinae plane block for perioperative analgesia in an adolescent patient undergoing major thoracic surgery with multiple rib resection: A case report. [2023]

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

Erector Spinae Plane Catheter for Postoperative Analgesia After Thoracotomy in a Pediatric Patient: A Case Report. [2021]