Erector Spinae Block for Post-Surgery Pain in Lung Cancer

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

Trial Summary

What is the purpose of this trial?

The aim of this study is to determine if erector spinae injections with bolus infusions with local anesthetic decrease postsurgical pain and opioid consumption in patients undergoing pulmonary resection surgery.

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 data supports the effectiveness of the treatment Erector Spinae Plane Block (ESPB) for post-surgery pain in lung cancer?

Research shows that the Erector Spinae Plane Block (ESPB) can effectively reduce pain after thoracic surgery, such as lung surgeries, and is comparable to other pain management techniques like the paravertebral block. It is considered a simple and safe method for managing post-operative pain. ^{1 2 3 4 5}

Is the Erector Spinae Plane Block (ESPB) safe for humans?

The Erector Spinae Plane Block (ESPB) is considered a relatively simple and safe technique for pain management after thoracic surgery, with fewer adverse effects compared to other methods like thoracic epidural and paravertebral blocks. ^{1 2 3 4 6}

How does the erector spinae plane block treatment differ from other treatments for post-surgery pain in lung cancer?

The erector spinae plane block (ESPB) is a unique treatment for managing post-surgery pain in lung cancer patients because it is a regional anesthesia technique that involves injecting anesthetic near the spine to block pain signals. Unlike systemic pain medications, ESPB targets specific nerves, potentially reducing the risk of respiratory complications and providing effective pain relief with fewer side effects. ^{1 3 4 7 8}

Eligibility Criteria

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.

I am between 18 and 90 years old.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Analgesic efficacy of erector spinae plane block versus paravertebral block in lung surgeries-A non-inferiority randomised controlled trial. [2023]

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

The erector spinae plane block for effective analgesia after lung lobectomy: Three cases report. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Erector Spinae Plane Block versus Paravertebral Block after Thoracic Surgery for Lung Cancer: A Propensity Score Study. [2023]

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

Efficacy of Erector Spinae Plane Block for Analgesia in Thoracic Surgery: A Systematic Review and Meta-Analysis. [2022]

5. Germany 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. [2020]

6. England 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. [2023]

7. United States 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. [2021]

8. 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]