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)

Trial Summary

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 data supports the effectiveness of the treatment Erector Spinae Plane Block for back pain?

Research shows that the Erector Spinae Plane Block can help reduce pain and the need for opioids (strong painkillers) after lumbar spine surgeries, suggesting it might also be effective for back pain.12345

Is the Erector Spinae Plane Block generally safe for humans?

The Erector Spinae Plane Block is generally considered to have a favorable safety profile, but complications like priapism (a prolonged erection) and potential systemic toxicity have been reported. Large studies suggest few complications, but as its use increases, more side effects may be identified.26789

How is the erector spinae plane block treatment different from other treatments for back pain?

The erector spinae plane block is unique because it involves injecting a local anesthetic between muscle layers in the back to target the origin of spinal nerves, providing pain relief. This technique is relatively new and can be guided by ultrasound or fluoroscopy, making it a versatile option for managing both acute and chronic pain.310111213

What is the purpose of this trial?

The goal of this clinical trial is to learn if an erector spinae plane block (ESPB; a type of nerve block) works to reduce pain in adults presenting to the emergency department with low back pain. It will also learn if the ESPB reduces pain, disability, and return to work at 7 days. The main questions it aims to answer are:1. Does the ESPB reduce short-term pain in participants with low back pain?2. Does the ESPB reduce longer-term pain, reduce disability, and improve return to work and activities in participants with low back pain?Researchers will compare ESPB to a placebo (an injection that does not involve a nerve block) to see if ESPB works to treat low back pain.Participants will:Receive either the ESPB or a placebo injection in the emergency department Report their pain scores for up to 120 minutes Report their pain, disability, and return to work at 7 days

Research Team

MG

Michael Gottlieb, MD

Principal Investigator

Rush University Medical Center

Eligibility Criteria

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

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)

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Erector Spinae Plane BlockExperimental Treatment1 Intervention
This group will receive the erector spinae plane block
Group II: Sham ProcedurePlacebo Group1 Intervention
This group will receive a sham injection.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials
448
Recruited
247,000+

Findings from Research

The erector spinae plane (ESP) block significantly reduced postoperative fentanyl consumption and pain scores (VAS) at one hour after lumbar herniated disc surgery, indicating effective pain management shortly after the procedure.
Patients receiving the ESP block did not require intraoperative opioids, suggesting that this technique may enhance overall opioid-sparing strategies during surgery.
Is Opioid-free Anesthesia Possible by Using Erector Spinae Plane Block in Spinal Surgery?TaลŸkaldฤฑran, Y.[2021]
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., Pestaรฑa, P., et al.[2023]
The erector spinae plane (ESP) block effectively distributes local anesthetic, as shown by the presence of methylene blue in multiple intercostal spaces and the paravertebral space, indicating its potential for pain management.
The exact pathway through which the anesthetic travels from the posterior to the anterior thorax remains unclear, suggesting that further research is needed to fully understand the mechanism of action of the ESP block.
Erector spinae plane block: A cadaver study to determine its mechanism of action.Vidal, E., Gimรฉnez, H., Forero, M., et al.[2022]

References

Is Opioid-free Anesthesia Possible by Using Erector Spinae Plane Block in Spinal Surgery? [2021]
Erector Spinae Plane Block on Postoperative Pain and Opioid Consumption After Lumbar Spine Surgery: A Systematic Review and Meta-analysis of Randomized Controlled Trials. [2023]
Erector spinae plane block: A cadaver study to determine its mechanism of action. [2022]
Bilateral Erector Spinae Plane Block for Quality of Recovery Following Posterior Lumbar Interbody Fusion: A Randomized Controlled Trial. [2023]
Erector Spinae Plane Block in the Emergency Department for Upper Extremity: A Case Report. [2021]
Priapism following erector spinae plane block for the treatment of a complex regional pain syndrome. [2019]
Population pharmacokinetic and safety analysis of ropivacaine used for erector spinae plane blocks. [2023]
Comparison of analgesic efficacy of different local anesthetic volumes for erector spinae plane block in thoracotomy patients; a prospective randomized trial. [2023]
Procedure-Specific Complications Associated with Ultrasound-Guided Erector Spinae Plane Block for Lumbar Spine Surgery: A Retrospective Analysis of 342 Consecutive Cases. [2022]
Erector spinae plane block: a systematic qualitative review. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Anatomical evaluation of the extent of spread in the erector spinae plane block: a cadaveric study. [2022]
Erector spinae plane block: Relatively new block on horizon with a wide spectrum of application - A case series. [2020]
Fluoroscopic-guided erector spinae plane block for spine surgery. [2022]
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