62 Participants Needed

Erector Spinae Plane Block for Back Pain

AO
MS
Overseen ByMichelle Santangelo, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Rush University Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the erector spinae plane block (ESPB), a type of nerve block, can reduce pain in people with low back pain visiting the emergency department. The researchers aim to determine if this treatment not only eases pain immediately but also reduces pain and disability and improves the ability to return to normal activities after a week. Participants will receive either the ESPB or a placebo injection for comparison. Ideal candidates are adults who have experienced low back pain for less than six weeks.

As an unphased trial, this study allows participants to contribute to innovative pain management research.

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 the erector spinae plane block is safe for treating low back pain?

Research has shown that the erector spinae plane block (ESPB) can effectively reduce pain. In one study, a patient experienced about 90% improvement in low back pain. Another study found that ESPBs reduced the need for opioid painkillers without altering pain levels, offering a safer way to manage pain.

Regarding safety, current information is mostly reassuring. However, safety data remains limited, especially for individuals taking blood-thinning medications. Most safety information comes from small studies, so researchers do not yet have large-scale safety data. Still, existing reports have not shown major safety concerns.

For those considering ESPB, it's important to know that while it appears promising, more research is needed to fully understand its safety.12345

Why are researchers excited about this trial?

The Erector Spinae Plane Block is unique because it targets back pain through a novel mechanism: a regional anesthetic technique that directly numbs the nerves around the spinal column. This approach is different from typical treatments like oral pain medications or physical therapy, which don't specifically block nerve signals. Researchers are excited because this technique has the potential to provide pain relief more directly and immediately, reducing the need for systemic painkillers and their associated side effects. Additionally, it might offer a non-invasive alternative to more invasive procedures like spinal injections or surgery.

What evidence suggests that the erector spinae plane block is effective for low back pain?

Research has shown that the erector spinae plane block (ESPB), which participants in this trial may receive, can greatly reduce pain. In one study, 78% to 83% of patients reported excellent to moderate relief from low back pain after receiving the ESPB. Another report highlighted a patient who experienced about 90% improvement in pain. Studies have also found that ESPB significantly lowered pain scores within a few hours, reducing the need for additional pain medication. Overall, the ESPB appears to be very effective in managing low back pain and helping patients feel better quickly.13678

Who Is on the Research Team?

MG

Michael Gottlieb, MD

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 who come to the emergency department with low back pain that's been there for less than six weeks. It's not specified, but typically people with certain health conditions or those on conflicting medications might be excluded.

Exclusion Criteria

Are incarcerated
Have a known pregnancy
Are allergic to amide-type local anesthetics
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day
1 visit (in-person)

Treatment

Participants receive either the ESPB or a placebo injection in the emergency department

1 day
1 visit (in-person)

Immediate Follow-up

Participants report their pain scores for up to 120 minutes post-intervention

120 minutes
1 visit (in-person)

Follow-up

Participants report their pain, disability, and return to work at 7 days

7 days
1 visit (virtual or in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Erector Spinae Plane Block
Trial Overview The study is testing if an erector spinae plane block (ESPB), a type of nerve block, can reduce acute and longer-term low back pain compared to a sham procedure (placebo injection). Participants will report their pain up to two hours after treatment and again at seven days.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Erector Spinae Plane BlockExperimental Treatment1 Intervention
Group II: Sham ProcedurePlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials
448
Recruited
247,000+

Published Research Related to This Trial

The Erector Spinae Plane Block (ESPB) is a new technique for pain management that involves injecting local anesthetic between the erector spinae muscle and the transverse process, which has been generally considered safe.
Despite its safety profile, there is a potential for complications, as demonstrated by a case where a patient developed priapism following the ESPB, highlighting the need for careful monitoring as the technique becomes more widely used.
Priapism following erector spinae plane block for the treatment of a complex regional pain syndrome.Elkoundi, A., Eloukkal, Z., Bensghir, M., et al.[2019]
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.
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 (ESP) block significantly reduces pain scores in the first 48 hours after lumbar spine surgery, both at rest and during activity, based on a systematic review of 22 randomized controlled trials involving 1,327 patients.
Using the ESP block also leads to decreased opioid consumption and fewer patients needing rescue analgesics, which contributes to lower rates of postoperative nausea and vomiting and higher patient satisfaction scores.
Erector Spinae Plane Block on Postoperative Pain and Opioid Consumption After Lumbar Spine Surgery: A Systematic Review and Meta-analysis of Randomized Controlled Trials.Wilson, AA., Schmid, AM., Pestaña, P., et al.[2023]

Citations

A randomized clinical trial of erector spinae plane block ...The primary hypothesis of this study was that ESPB reduces the incidence of chronic pain for 3 months after posterior lumbar surgery.
Erector Spinae Plane Block for Chronic Lumbosacral PainFollowing the ESP block, the patient reported a significant reduction in his low back pain, with approximately 90% improvement in his pain ...
Efficacy of erector spine plane block in two different ...ESPB significantly reduced pain intensity at rest in both surgical approaches 48 h after surgery (p < 0.05). The need for postoperative fentanyl infusion was ...
Ultrasound Guided Erector Spinae Plane Block for Pain ...Lower NRS at 1-hour and greater reduction in NRS at 1, 3, 5, and 10-hours in ESPB group; fewer patients in ESPB group required rescue analgesia ...
5.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/37976481/
Comparison of the Low Back Pain Relief and Spread Level ...Results: The number of patients who showed excellent-to-moderate low back pain relief was 35 (83.3%) and 36 (78.5%) in the L2 and L4 ESPB groups, respectively.
Impact of Erector Spinae Plane Blocks on Pain Management ...ESPBs were associated with statistically and clinically significant reductions in 24-hour opioid consumption and LOS, without differences in NRS pain scores ...
Efficacy of erector spine plane block in two different ...ESPB significantly reduced pain intensity at rest in both surgical approaches 48 h after surgery (p < 0.05). The need for postoperative fentanyl infusion was ...
The Safety and Outcome of Erector Spinae Plane Block in ...However, the safety of ESPB in patients being treated with antiplatelets and anticoagulants is based on limited clinical data, mostly from single case series.
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