Erector Spinae Block for Post-Surgery Pain in Lung Cancer

Recruiting at 1 trial location

Overseen By Eduard Shaykhinurov

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: George Washington University

Disqualifiers: Pleurodesis, Decortication, Emergent surgery, others

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

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether an erector spinae block (a type of pain relief injection) can reduce pain and the need for opioids after lung surgery. Participants will receive either this injection with standard care or standard care alone. It suits those undergoing lung surgery, known as pulmonary resection, who have no allergies to local anesthetics or other listed exclusions. The goal is to determine if this block can ease post-surgery discomfort and reduce opioid use. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment can benefit more patients.

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

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

What is the safety track record for the ESB Thoracic treatment?

Research shows that the erector spinae block (ESB) is under consideration for pain relief after lung surgery. Studies have found that ESB can reduce pain for up to 24 hours post-surgery, offering a promising option for pain management.

However, while ESB might alleviate pain, the safety information remains mixed. Some reports advise caution due to varying evidence on its safety and effectiveness. Although no major safety issues have been identified, the quality of the evidence is not very strong.

In summary, ESB could lessen pain after surgery, but those considering it should be aware that the safety evidence is still developing. Always consult a healthcare provider to make the best decision for your situation. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the erector spinae block (ESB) for post-surgery pain in lung cancer because it offers a new way to manage pain more effectively. Unlike standard treatments that typically rely on opioids and other systemic pain relievers, ESB targets the nerves directly near the spine, potentially providing more localized and efficient pain relief. This technique might reduce the need for higher doses of opioids, leading to fewer side effects like nausea and sedation, which are common with traditional pain management strategies. By offering a more targeted approach, ESB could enhance recovery times and improve the overall quality of life for patients after lung surgery.

What evidence suggests that the Erector Spinae Block is effective for post-surgery pain in lung cancer?

Research has shown that erector spinae plane (ESP) blocks effectively reduce post-surgical pain. Studies have found that continuous ESP blocks significantly decrease opioid use and lower pain levels in the first 48 hours after surgery. A review of multiple studies found that ESP blocks reduce pain at various times post-surgery, both at rest and during movement. Additionally, ESP blocks have been associated with less pain 24 hours after certain lung cancer surgeries compared to other pain management methods. In this trial, one group of participants will receive the ESP block alongside standard care, while the other group will receive standard care without the ESP block. This treatment has proven effective for managing pain, especially in cancer patients. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults aged between 18 and 90 who are scheduled to have lung surgery (pulmonary resection). It's not suitable for those needing emergency surgery, procedures like decortication or pleurodesis, people allergic to local anesthetics, or if there are complications during surgery such as heavy bleeding.

Inclusion Criteria

I have had surgery to remove part of my lung.

Exclusion Criteria

I had complications during surgery, like unexpected bleeding or a change to open surgery.

I need urgent surgery.

I have had surgery to remove the outer layer of my lung.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive erector spinae blocks with bolus infusions of local anesthetic during pulmonary resection surgery

1 day

1 visit (in-person, surgical procedure)

Immediate Postoperative Monitoring

Pain scores and medication usage are recorded at 6, 12, and 24 hours postoperatively

24 hours

Continuous monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a phone call within 72 hours to review the Pain Diary

1 week

1 phone call

What Are the Treatments Tested in This Trial?

Interventions

• ESB Thoracic

Trial Overview The study is testing whether erector spinae injections with a continuous infusion of local anesthetic can reduce pain and the need for opioid painkillers after lung surgery. The focus is on improving postoperative recovery.

How Is the Trial Designed?

Group I: Standard of Care + ESB Thoracic Experimental Treatment 1 Intervention

Patients randomized to this group will receive an erector spinae block in addition to the standard of care treatment

Group II: Standard of Care Active Control 1 Intervention

Patients randomized to this group will receive standard of care treatment and NO erector spinae block

Who Is Running the Clinical Trial?

George Washington University

Lead Sponsor

Trials

263

Recruited

476,000+

Published Research Related to This Trial

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 involving patients undergoing thoracotomy, a 30 ml dose of bupivacaine for the erector spinae plane block (ESPB) provided significantly better pain relief compared to a 20 ml dose, as indicated by lower visual analog scale (VAS) scores for both resting and coughing at multiple time points post-surgery.

Both doses of bupivacaine resulted in similar side effect rates, suggesting that the 30 ml dose is not only more effective for pain management but also safe for use in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of analgesic efficacy of different local anesthetic volumes for erector spinae plane block in thoracotomy patients; a prospective randomized trial. Zengin, M., Sazak, H., Baldemir, R., et al.[2023]

The erector spinae plane block (ESPB) significantly reduces postoperative opioid consumption and pain scores after thoracic surgery, based on a systematic review of 17 studies involving 1,092 patients.

ESPB is associated with a lower incidence of hematoma compared to other regional analgesic techniques, making it a safer option for managing postoperative pain, despite being less effective than thoracic paravertebral and intercostal nerve blocks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Erector Spinae Plane Block for Analgesia in Thoracic Surgery: A Systematic Review and Meta-Analysis. Koo, CH., Lee, HT., Na, HS., et al.[2022]

The erector spinae plane block (ESPB) is a simple and safe technique for providing effective pain relief after thoracic surgery, as demonstrated in three patients undergoing lobectomy, where pain scores remained below 3 for five days without the need for additional analgesics.

Imaging data from computed tomography showed that the local anesthetic spread effectively around the thoracic region, confirming the mechanism of action for ESPB and supporting its use as a multimodal analgesia option in postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The erector spinae plane block for effective analgesia after lung lobectomy: Three cases report. Bang, S., Chung, K., Chung, J., et al.[2022]

In a study of 60 patients undergoing video-assisted thoracic surgery (VATS), those who received a preoperative ultrasound-guided erector spinae plane block (ESPB) experienced significantly lower opioid consumption and pain scores compared to the control group, indicating effective pain management.

The ESPB group also reported fewer instances of nausea and itching, suggesting that this technique may enhance postoperative comfort and reduce side effects associated with opioid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of an Ultrasound-Guided Erector Spinae Plane Block for Postoperative Analgesia Management After Video-Assisted Thoracic Surgery: A Prospective Randomized Study. Ciftci, B., Ekinci, M., Celik, EC., et al.[2021]

The Erector Spinae Plane Block (ESPB) was found to be less effective than the Paravertebral Block (PVB) for pain management after lung surgeries, with higher pain scores reported in the ESPB group (mean NRS 4.6 vs 3.9).

Patients receiving ESPB required more postoperative opioids and experienced a higher failure rate of analgesia compared to those receiving PVB, indicating that ESPB may not be a suitable alternative for effective pain control in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic efficacy of erector spinae plane block versus paravertebral block in lung surgeries-A non-inferiority randomised controlled trial. Andrade Filho, PH., Pereira, VE., Sousa, DDEM., et al.[2023]

In a study of 107 patients undergoing video or robot-assisted thoracic surgery, the erector spinae plane block (ESPB) resulted in significantly lower post-operative pain scores at rest and during cough compared to the paravertebral block (PVB) at 24 hours post-surgery.

Both ESPB and PVB showed similar levels of post-operative morphine consumption and respiratory complications, indicating that ESPB is a safe and effective alternative for pain management after thoracic surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Erector Spinae Plane Block versus Paravertebral Block after Thoracic Surgery for Lung Cancer: A Propensity Score Study. Durey, B., Djerada, Z., Boujibar, F., et al.[2023]

Continuous erector spinae plane block (ESPB) was successfully performed in a 62-year-old patient taking aspirin after coronary artery bypass grafting, demonstrating its safety in patients on antithrombotic therapy.

The ESPB provided effective analgesia post-surgery, with the patient experiencing no complications and achieving loss of cold sensation from T2 to T8, indicating successful pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous erector spinae plane block for analgesia of sternum closure using a latissimus dorsi muscle flap for mediastinitis after coronary artery bypass grafting: a case report. Yamane, Y., Kosaka, M., Akiizumi, H., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11055569/

Prolonged Effect of Repetitive Erector Spinae Plane Block ... We observed a prolonged effect of repeated ESPBs for ≥3 months. The block efficacy decreased with time; however, an approximately 50% reduction in the VAS ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12512273/

Comparative efficacy of erector spinae plane block versus ... [11] reported that continuous ESP block significantly reduced opioid requirements and resulted in lower pain scores than ICNB in the first 48 h ...

3. journals.lww.com journals.lww.com/ijpn/fulltext/2023/37020/erector_spinae_plane_block_for_cancer_pain___a.3.aspx

Erector Spinae Plane Block for Cancer Pain – A Scoping... The current literature suggests that the ESP block can be helpful in cancer pain management. However, caution must be exercised not to overestimate the safety.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1743919120304210

Effects of erector spinae plane block on postoperative pain ... This meta-analysis showed that ESP block could significantly reduce patients' pain scores at 1 h, 6 h, 12 h, and 24 h after surgery at rest or during movement.

5. mdpi.com mdpi.com/2072-6694/15/8/2306

Erector Spinae Plane Block versus Paravertebral ... Conclusions: Our results suggest that ESPB is associated with less post-operative pain at 24 h than PVB after VATS or RATS for lung cancer.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11566050/

Erector spinae plane block for cancer pain relief: a systematic ... The evidence supporting the use of ESPB for cancer pain management is currently scarce, heterogeneous, and of low quality.