Erector Spinae vs Intercostal Nerve Blocks for Pain in Thoracic Surgery

Recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods for managing pain after thoracic surgery, such as lung or chest wall surgeries. It compares the effectiveness of an erector spinae block, which uses bupivacaine, with an intercostal nerve block that uses a longer-lasting form of bupivacaine. Individuals who have undergone video-assisted lung surgery or similar procedures and do not have allergies to local anesthetics may be suitable candidates. The trial aims to determine which method provides better pain relief after surgery. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking pain management solutions.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that using erector spinae blocks with bupivacaine was safe. Patients experienced less pain and required fewer strong painkillers. This method also reduced nausea and vomiting after surgery.

Research has shown that intercostal nerve blocks with liposomal bupivacaine are safe and provide effective pain relief post-surgery. One study found that this type of block managed pain well without major side effects.

Both treatments aim to control pain effectively and safely. Evidence suggests they are well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer new ways to manage pain after thoracic surgery. The erector spinae block (ESB) uses bupivacaine (Marcaine®) and targets the nerves in the back near the spine, potentially providing broader pain relief with fewer side effects compared to traditional intercostal nerve blocks. The intercostal nerve block (INB) in this study uses liposomal bupivacaine (Exparel®), which is designed to release the medication slowly, possibly extending pain relief and reducing the need for opioids. Both approaches aim to enhance recovery by managing pain more effectively and safely.

What evidence suggests that this trial's treatments could be effective for pain in thoracic surgery?

This trial will compare the effectiveness of two pain management techniques for thoracic surgery: the Erector Spinae Block (ESB) with Bupivacaine and the Intercostal Nerve Block (INB) with Liposomal Bupivacaine. Studies have shown that bupivacaine in an erector spinae block can reduce pain after chest surgery. While effective for pain relief, some patients may still experience moderate to severe pain. In contrast, intercostal nerve blocks with liposomal bupivacaine have proven very effective. Research indicates that this treatment can significantly reduce pain and help patients recover faster by enabling earlier movement after surgery. Both treatments offer promising options for managing pain after chest surgery. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12532356/

Effect of erector spinae plane block on overall benefit ... Liposomal bupivacaine, a sustained-release formulation, provides prolonged analgesia for up to 72 h and may enhance postoperative pain ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07141667?term=NA

Randomized Trial of Erector Spinae Plane Block Using ... Nevertheless, 27-63% of VATS patients still develop moderate to severe postoperative pain, with the incidence of chronic postsurgical pain (CPSP) ...

3. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1359878/full

Effect of liposomal bupivacaine for preoperative erector ... This study aims to determine the effect of LB versus bupivacaine hydrochloride (HCl) for preoperative ultrasound-guided erector spinae plane block (ESPB) on ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022480423001178

Erector Spinae Plane Block With Liposomal Bupivacaine ESPB with liposomal bupivacaine may be considered as an analgesic adjunct to enhance recovery in patients undergoing cardiothoracic procedures.

5. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-023-02004-4

Comparison of analgesic efficacy of different local anesthetic ... Thoracic paravertebral block achieves better pain control than erector spinae plane block and intercostal nerve block in thoracoscopic surgery: ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12072521/

Effectiveness and Safety of Erector Spinae Plane Block vs. ... The secondary outcomes included the pain scores and adverse events. Results: A total of 61.2% of the 165 included VATS patients and 56.9% of the ...

7. eurjmedres.biomedcentral.com eurjmedres.biomedcentral.com/articles/10.1186/s40001-025-03174-2

Comparison of liposomal bupivacaine erector spinae plane ... This study aimed to compare the efficacy of liposomal bupivacaine ultrasound-guided erector spinae plane block (ESPB) with wound infiltration ( ...