48 Participants Needed

ESP Block for Spinal Surgery

SQ
Overseen BySheeraz Qureshi, MD, MBA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Hospital for Special Surgery, New York
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 whether an erector spinae plane (ESP) block, a pain management technique, can improve outcomes for individuals undergoing minimally invasive lumbar spine surgery. Participants will be randomly assigned to one of two groups: one receiving the ESP block and the other not receiving it. The study aims to determine if the ESP block affects recovery and pain management after surgery. It suits individuals scheduled for minimally invasive spinal fusion surgery who have not had previous lumbar surgery and do not rely on daily opioid use. As an unphased trial, it offers participants the chance 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. However, if you are using opioids daily for more than 3 months, you would not be eligible to participate.

What prior data suggests that the ESP block is safe for spinal surgery?

Research has shown that the erector spinae plane (ESP) block is generally safe for individuals undergoing spinal surgery. Studies have found that ESP blocks reduce post-surgery pain and decrease the need for painkillers like opioids. Using fewer opioids often results in fewer side effects, such as nausea or drowsiness.

In one study, patients who received an ESP block experienced less nausea and vomiting after surgery. Another study found that it reduced pain and the need for medication during and after surgery, suggesting that the ESP block is well-tolerated.

For those considering joining a trial, these findings can be reassuring. The ESP block is not new and has been well-studied for safety in spinal surgeries.12345

Why are researchers excited about this trial?

Researchers are excited about using the erector spinae plane (ESP) block for spinal surgery because it offers a new approach to pain management. Unlike traditional options like general anesthesia or opioid-based pain relief, the ESP block targets nerves near the spine directly, potentially providing more localized pain control. This method could reduce the need for opioids, which have significant side effects and addiction risks. Additionally, the ESP block might offer faster pain relief and recovery, making the surgical experience smoother for patients.

What evidence suggests that the ESP block is effective for spinal surgery?

Research has shown that the erector spinae plane (ESP) block, which participants in this trial may receive, can effectively reduce pain after spinal surgery. In one study, patients who received the ESP block reported less pain during the first three days after their surgery. Another study found that the ESP block decreased the need for opioids (strong painkillers) within 24 hours after surgery. Additionally, patients felt more satisfied and experienced less nausea after receiving the ESP block. Overall, these findings suggest that the ESP block is useful for managing pain after lower spine surgery.678910

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 who are scheduled to undergo minimally invasive surgery for spinal stenosis. Participants should be in a stable health condition, classified as ASA 1, 2, or 3 by anesthesiologists.

Inclusion Criteria

My health is good to moderately impaired.
I am scheduled for a minimally invasive spine surgery with the principal investigator.

Exclusion Criteria

Chronic opioid use (daily use for > 3 months)
Non-English speaking
I have had previous surgery on my lower back.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Assessment

Preoperative patient demographics, comorbidities, history of opioid use, and operative details will be obtained

1 week

Treatment

Patients undergo minimally invasive transforaminal lumbar interbody fusion with or without ESP block

1 day
1 visit (in-person)

Postoperative Monitoring

Comprehensive assessment of opioid utilization, postoperative pain, non-opioid pain medication use, and opioid-induced complications

24 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment, including time to opioid cessation and physical therapy clearance

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Erector spinae plane (ESP) block
Trial Overview The study is testing the effectiveness of the Erector Spinae Plane (ESP) block compared to no ESP block in patients having minimally invasive spine surgery. It's a randomized controlled trial which means participants will be randomly assigned to one of the two groups.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: ESP BlockExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials
257
Recruited
61,800+

Published Research Related to This Trial

The erector spinae plane (ESP) block provided over 50% pain relief for a 66-year-old man suffering from cervicothoracic junction pain due to a Pancoast tumor after just two sessions.
This regional anesthetic technique is shown to be convenient and safe, potentially reducing the need for opioids, although further research is necessary to assess the long-term safety and effectiveness of continuous ESP blocks in outpatient settings.
Erector Spinae Plane Block for the Treatment of Intractable Pain in a Patient with Pancoast Tumor: A Case Report.Rahimzadeh, P., Ahani, A., Antar, A., et al.[2023]
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.
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]
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.
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]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/30424594/
Efficacy of the Erector Spinae Plane Block for Lumbar ...Conclusions: The ESP block provides effective postoperative analgesic effect for 24 hours in patients undergoing lumbar spinal surgery. Keywords ...
A randomized clinical trial of erector spinae plane block ...A recent study revealed that ESPB reduced chronic postsurgical pain for 3 months after minimally invasive thoracic surgery. For this reason, ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40019151/
Effect of Lumbar Erector Spinae Plane Blocks After ...Conclusions: The patient population that received the erector spinae block had significantly lower pain scores on days 1-3 postsurgery, showing ...
Analgesic efficacy of erector spinae plane block in lumbar ...ESPB improved analgesic efficacy by reducing opioid consumption 24 h after surgery. •. ESPB increased patient satisfaction and decreased postoperative nausea ...
The efficacy of lumbar erector spinae plane block for ...These results indicate that L-ESPB can still provide effective intraoperative and postoperative analgesia despite the flushing effect of large ...
Efficacy and Safety of Erector Spinae Plane Block ...This meta-analysis demonstrated that ESPB used in lumbar spinal surgery was effective in relieving postoperative pain, decreasing the perioperative consumption ...
7.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/37163199/
Efficacy and Safety of Erector Spinae Plane Block for ...In terms of opioid-related adverse reactions, ESPB reduced the incidence of postoperative nausea, vomitting, somnolence and itching in ...
Efficacy and Safety of Bilateral Ultrasound-Guided Erector ...A meta-analysis of randomized controlled trials was conducted to assess efficacy and safety of bilateral ultrasound-guided erector spinae plane block (ESPB) for ...
Erector spinae plane block for postoperative analgesia in ...Conclusions: The ESP block demonstrates potential as a multimodal analgesia component in vertebral surgeries, reducing opioid consumption, pain ...
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 ...
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