66 Participants Needed

Erector Spinae Plane Block for Postoperative Pain

RJ
MP
Overseen ByMichael P Stauff, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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.12345

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.13467

Who Is on the Research Team?

MS

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
See 4 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Erector Spinae Plane BlockExperimental Treatment1 Intervention
Group II: Subcutaneous AnesthesiaActive Control1 Intervention

Find a Clinic Near You

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.
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.
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.
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]

Citations

Erector Spinae Plane (ESP) Block for Postoperative Pain ...We found ESP blocks to be a safe, technically simple, and effective treatment for postoperative pain management after elective oncologic abdominal procedures.
Erector spinae plane block for postoperative analgesia in ...This umbrella review synthesizes data from systematic reviews (SRs) and meta-analyses to evaluate the effectiveness of the ESP block in reducing ...
Efficacy of erector spinae plane block for postoperative...This meta-analysis was designed to assess the effectiveness of ESPB as a perioperative analgesic technique when compared with conventional analgesia (control) ...
Bilateral erector spinae plane block for postoperative pain ...There was a significant pain relief in ESPB group, as compared to placebo across all timelines such as during immediate post-operative period (p < 0.001), 4 h ( ...
Effects of erector spinae plane block on intraoperative ...This study evaluates ESPB's efficacy in enhancing patient safety and postoperative pain management in spinal fusion. Fig. 1. figure 1. Visible ...
Ultrasound Guided Erector Spinae Plane Block for Pain ...Further research should focus on standardizing techniques, enhancing safety monitoring, and conducting high-quality studies to support broader ...
Erector spinae plane block for postoperative painThe primary outcomes were postoperative pain at rest at 24 hours and block‐related adverse events. Secondary outcomes were postoperative pain ...
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