Erector Spinae Plane Block for Postoperative Pain

Overseen By Michael P Stauff, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Raj Gala

Must not be taking: Opioids

Disqualifiers: Pregnancy, Non-English speakers, Prisoners, others

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

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

Compensation: Varies

Number of Visits: 1

Duration: Surgery day

66 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods of pain management after lumbar fusion surgery to determine which reduces pain and opioid use more effectively. It compares subcutaneous anesthesia (an injection under the skin) with an erector spinae plane block (an injection along the back muscles and bones, guided by a special x-ray). The researchers aim to discover if the erector spinae method results in less pain and reduced opioid use. This trial suits adults undergoing lumbar spinal fusion surgery who have not recently used high doses of opioids and have a BMI under 40. As an unphased trial, it offers patients the chance to contribute to innovative pain management research that could improve recovery experiences for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these anesthesia methods are safe for postoperative pain management?

Research has shown that the erector spinae plane block (ESPB) is safe and effective for managing post-surgical pain. One study found it to be a simple and reliable method for reducing pain after major surgeries, suggesting it can alleviate pain without serious complications.

Some studies indicate the need for further research to standardize the procedure and enhance safety monitoring. However, current findings generally show that patients tolerate ESPB well. Serious side effects are not commonly reported, which positively reflects its safety.

Overall, while more high-quality studies are needed, the available evidence supports the ESPB's safety in treating post-surgical pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for postoperative pain involve standard subcutaneous anesthesia techniques, which work by numbing the area around a surgical incision after the procedure. However, the erector spinae plane block (ESPB) stands out because it is administered before the surgery begins, targeting the erector spinae fascial plane with a precise injection technique guided by fluoroscopy. This method aims to provide more effective and longer-lasting pain relief by directly blocking pain signals at their source. Researchers are excited about ESPB because it could lead to better pain management and quicker recovery times for patients compared to traditional methods.

What evidence suggests that this trial's methods could be effective for postoperative pain?

Research has shown that the erector spinae plane block (ESPB), which participants in this trial may receive, effectively manages post-surgical pain. Studies have found that ESPB provides significant pain relief compared to a placebo, particularly immediately after surgery. Reviews of multiple studies indicate that ESPB can reduce the need for opioids post-surgery, benefiting recovery. The technique is considered safe and easy to perform during surgery. Overall, ESPB is a promising option for reducing pain and opioid use after operations like lumbar fusion. ^{1 3 4 6 7}

Who Is on the Research Team?

Michael Stauff, MD

Principal Investigator

UMass Chan Medical School

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are skeletally mature and scheduled for one or two level lumbar spinal fusion surgery. They must have signed a consent form approved by the Institutional Review Board at UMMHC.

Inclusion Criteria

The individual has signed and dated a study specific informed consent form approved by the Institutional Review Board at UMMHC

I am scheduled for a lumbar spinal fusion surgery involving one or two levels.

Exclusion Criteria

Non-English speaking subjects

Prisoners

Pregnant women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either an erector spinae plane block or subcutaneous anesthesia during lumbar fusion surgery

Surgery day

1 visit (in-person)

Postoperative Monitoring

Participants' opioid usage and pain levels are tracked for 2 weeks post-surgery

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment using SF-36 and Oswestry Disability Index

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Erector Spinae Plane Block
• Subcutaneous Anesthesia

Trial Overview

The study compares two local anesthesia methods: subcutaneous injections (under the skin) versus erector spinae plane block (ESPB), which places anesthesia along back muscles using fluoroscopy guidance, to see if they affect post-surgery pain and opioid use.

How Is the Trial Designed?

Group I: Erector Spinae Plane Block Experimental Treatment 1 Intervention

An erector spinae plane block (ESPB) will be administered prior to the surgical procedure, but after the patient receives general anesthesia. The injection will consist of 10 mL of saline, 20 mL of liposomal bupivacaine, and 30 mL of bupivacaine. This will be injected along the erector spinae fascial plane at the surgical levels. Fluoroscopy will be used for guidance during the injection.

Group II: Subcutaneous Anesthesia Active Control 1 Intervention

A subcutaneous anesthesia injection will be administered after the surgery has been completed, but while the patient is under general anesthesia. The injection will consist of 10 mL of saline, 20 mL of liposomal bupivacaine, and 30 mL of bupivacaine. This will be injected around the surgical incision, subcutaneously.

Who Is Running the Clinical Trial?

Raj Gala

Lead Sponsor

Trials

1

Recruited

70+

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

Published Research Related to This Trial

Patients receiving the erector spinae plane block (ESPB) with ropivacaine after lumbar fusion surgery required significantly less oxycodone and remifentanil compared to those receiving a saline mock block, indicating effective pain management.

The ropivacaine group also reported lower pain scores post-surgery and demonstrated areas of cold hypoesthesia, suggesting effective sensory blockade, while maintaining a safety profile comparable to the saline group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes of Opioid Consumption After Lumbar Fusion Using Ultrasound-Guided Lumbar Erector Spinae Plane Block: A Randomized Controlled Trial. Zhu, L., Wang, M., Wang, X., et al.[2021]

Pre-operative bilateral erector spinae plane block (ESPB) significantly improved recovery after posterior lumbar surgery, as indicated by higher alertness scores (MOAA/S) at 10 minutes post-extubation compared to the control group.

Patients receiving the ESPB required less intraoperative and postoperative opioid medication, leading to reduced opioid consumption and quicker ambulation after surgery, highlighting its efficacy in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral Erector Spinae Plane Blocks for Open Posterior Lumbar Surgery. Zhang, TJ., Zhang, JJ., Qu, ZY., et al.[2022]

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]

In a study of 80 patients undergoing lumbar spinal surgery, a two-level erector spinae plane (ESP) block was found to provide better sensory coverage of the surgical incision compared to a one-level block, with 100% coverage in the two-level group versus 85% in the one-level group.

Despite the two-level block taking longer to perform, it did not lead to increased complications or higher postoperative pain scores, indicating it is a safe and effective method for enhancing analgesia in spinal surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the feasibility and validity of a one-level and a two-level erector spinae plane block combined with general anesthesia for patients undergoing lumbar surgery. Zheng, S., Zhou, Y., Zhang, W., et al.[2023]

In a study of 55 patients undergoing percutaneous lumbar arthrodesis for trauma, those who received a bilateral erector spinae plane block (ESPB) required significantly less morphine (13 mg) compared to those who received standard postoperative care (35 mg), indicating that ESPB effectively reduces opioid consumption.

Patients in the ESPB group also reported lower pain scores for up to 9 hours post-surgery, suggesting that this technique not only decreases opioid needs but also provides better pain management in the immediate postoperative period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Bilateral Ultrasound-Guided Erector Spinae Plane Block in Percutaneous Lumbar Osteosynthesis for Spine Trauma: A Retrospective Study. Cirenei, C., Boussemart, P., Leroy, HA., et al.[2021]

The erector spinae plane block (ESPB) significantly reduces opioid consumption after surgeries such as breast, thoracic, and vertebral surgeries, indicating its effectiveness in postoperative pain management.

ESPB is a promising analgesic technique compared to no block and some alternative blocks, although it performed less effectively than the PECS block for breast surgery, highlighting the need for further refinement and understanding of its mechanism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The opioid sparing effect of erector spinae plane block for various surgeries: a meta-analysis of randomized-controlled trials. Fanelli, A., Torrano, V., Cozowicz, C., et al.[2022]

In a retrospective review of 182 patients, the erector spinae plane block (ESPB) was found to provide effective postoperative pain relief when used as part of a multimodal analgesia plan.

The study noted few complications associated with ESPB, highlighting its safety as a regional anesthesia technique for various thoracoabdominal pain indications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided Erector Spinae Plane Block: Indications, Complications, and Effects on Acute and Chronic Pain Based on a Single-center Experience. Tulgar, S., Selvi, O., Senturk, O., et al.[2020]

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]

The Erector Spinae Plane Block (ESPB) is an effective ultrasound-guided technique for managing postoperative pain, particularly in the thoracic and abdominal areas.

This study highlights the successful use of a fluoroscopic-guided ESPB specifically for lower back spinal surgery, suggesting its versatility and potential benefits in pain management for this type of procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluoroscopic-guided erector spinae plane block for spine surgery. Kim, E., Alshoubi, A.[2022]

The study found that both the erector spinae plane (ESP) block and paravertebral block (PVB) significantly reduced morphine consumption compared to a control group in 75 patients undergoing breast surgery, indicating effective postoperative pain management.

There was no significant difference in analgesic effectiveness between the ESP and PVB groups, suggesting that ESP block can be a viable alternative to PVB for postoperative pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Erector spinae plane block and thoracic paravertebral block for breast surgery compared to IV-morphine: A randomized controlled trial. Gürkan, Y., Aksu, C., Kuş, A., et al.[2021]

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