ESP Block for Post-Surgery Pain

Overseen By Michael Dinsmore, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Allergy to anesthetics, Pregnancy, others

Compensation: Varies

Number of Visits: 3

Duration: Immediate post-surgery

52 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a nerve block, called the Erector Spinae Plane (ESP) block, in reducing pain after spine surgery. Patients often experience significant pain following these surgeries, which can slow recovery and affect daily life. The trial tests whether an ESP block with a mix of local anesthetics (lidocaine and bupivacaine) manages pain better than a placebo (inactive treatment). It is open to adults undergoing certain types of spine surgeries, excluding those with conditions like spine fractures or tumors. As an unphased trial, this study offers patients the chance to contribute to research that could enhance pain management for future spine surgery 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 the ESP Block is safe for postoperative pain management?

Research has shown that the Erector Spinae Plane (ESP) block is generally safe for managing post-surgical pain. Studies have found that ESP blocks effectively reduce pain and decrease the need for painkillers after spinal surgeries. They are widely used and well-tolerated in these situations.

Using a combination of lidocaine and bupivacaine (types of local anesthetics) in ESP blocks has effectively lowered pain levels and reduced the need for other pain medications. Reports suggest that patients experience fewer side effects and complications compared to some other pain management methods. This indicates that the treatment is considered safe and well-tolerated for patients undergoing surgery.

For those considering participation in a clinical trial involving an ESP block, these findings may provide reassurance about its safety based on previous studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Erector Spinae (ESP) Block for post-surgery pain management because it offers a novel approach by specifically targeting the nerves around the spine to block pain signals more effectively. This method uses a precise mixture of Lidocaine and Bupivacaine, which are well-known anesthetics, providing potentially longer-lasting and more localized pain relief compared to traditional systemic pain medications like opioids or NSAIDs. The ESP Block is administered at the T1 level, which is thought to offer a more focused pain management solution, reducing the need for higher doses of oral pain medications and minimizing their side effects.

What evidence suggests that the ESP Block is effective for post-surgery pain?

Research has shown that the erector spinae plane (ESP) block can help manage pain after spine surgery. In this trial, participants in the study group will receive the ESP block with Lidocaine and Bupivacaine. Studies have found this combination results in less pain and a reduced need for painkillers. Participants also experienced longer intervals before needing additional pain relief. Pain relief immediately after surgery and during early recovery was significantly better with the ESP block compared to a placebo. This suggests that the ESP block can play an important role in managing pain after spine surgery, aiding recovery with less discomfort. ^{2 6 7 8 9}

Who Is on the Research Team?

Michael Dinsmore, MD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

Adults aged 18-80 with moderate health (ASA class I - III) who are having specific neck spine surgery for cervical stenosis can join. Not for those with certain spine conditions, very poor health (ASA IV), no consent, pregnancy, or allergy to local anesthetics.

Exclusion Criteria

My cancer is located in the cervical spine area.

Pregnant patient

Lack of informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a bilateral ESP block with a mixture of Lidocaine and Bupivacaine or a placebo saline solution at the T1 level

Immediate post-surgery

1 visit (in-person)

Follow-up

Participants are monitored for postoperative pain and opioid consumption using a visual analog scale and diary card

1 month

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Erector Spinae (ESP) Block with Lidocaine/Bupivacaine
• Erector Spinae (ESP) Block with placebo

Trial Overview

The trial is testing if a pain block called ESP with Lidocaine/Bupivacaine reduces opioid use and improves recovery after neck spine surgery compared to the same block using a placebo.

How Is the Trial Designed?

Group I: Study group Experimental Treatment 1 Intervention

Bilateral ESP block at T1 level with 20 ml of 1:1 mixture (2% Lidocaine: 0.5% bupivacaine)

Group II: Placebo Group Placebo Group 1 Intervention

Bilateral ESP block at T1 level with 20 ml of 0.9% normal saline

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Erector spinae plane block: A cadaver study to determine its mechanism of action. Vidal, E., Giménez, H., Forero, M., et al.[2022]

The erector spinae plane (ESP) block effectively spreads analgesic dye from the T1 to T11 levels in the dorsal region, indicating its potential for broad pain control in the thoracic area.

Importantly, the study found no diffusion of the contrast solution into the anterior region or paravertebral space, suggesting a targeted mechanism of action that minimizes the risk of affecting surrounding structures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anatomical evaluation of the extent of spread in the erector spinae plane block: a cadaveric study. Aponte, A., Sala-Blanch, X., Prats-Galino, A., et al.[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]

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]

The Erector Spinae Plane (ESP) block is a safe and effective regional anesthesia technique that can provide pain relief for various surgical procedures, including breast, thoracic, and abdominal surgeries, as well as chronic pain management.

In a series of six cases, both continuous and single-shot ESP blocks demonstrated successful postoperative pain control, highlighting the versatility of this technique in different clinical scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Erector spinae plane block: Relatively new block on horizon with a wide spectrum of application - A case series. Jain, K., Jaiswal, V., Puri, A.[2020]

In a case series of 10 patients undergoing bilateral erector spinae plane (ESP) block for lumbar spine surgery, lidocaine showed a rapid absorption with peak concentrations (Cmax) ranging from 1.2 to 3.8 mg/L, which remained below toxicity limits.

The pharmacokinetics of lidocaine after ESP block indicated high bioavailability (average AUC0-3 of 76%) and a slightly prolonged elimination half-life in older patients, suggesting that age may influence drug metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of lidocaine after bilateral ESP block. De Cassai, A., Bonanno, C., Padrini, R., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 is an effective regional anesthesia technique that provides both visceral and somatic pain relief for abdominal surgeries, potentially replacing thoracic epidural anesthesia.

In a series of six cases, the ESP block demonstrated superior analgesic effects compared to other regional anesthesia techniques, successfully managing postoperative pain in various abdominal surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Erector spinae plane block in various abdominal surgeries: A case series. Marija, T., Aleksandar, D.[2021]

The erector spinae plane block (ESPB) using liposomal bupivacaine effectively reduced postoperative pain in 18 patients undergoing spinal cord stimulation implant, leading to low pain scores.

Patients receiving the ESPB experienced decreased opioid consumption after surgery, indicating a potential for improved pain management and reduced reliance on opioids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing post-operative analgesia following spinal cord stimulation implant: a comprehensive evaluation of the effectiveness of erector spinae plane block utilizing liposomal bupivacaine. Sagir, A., Murphy, M., Teames, R., et al.[2023]

Citations

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Efficacy of erector spinae plane block for postoperative ...

ESP block provides less opioid consumption and PONV, lower pain scores, and longer time to first analgesic request in patients undergoing lumbar surgery.

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sciencedirect.com

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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 ( ...

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This study evaluated the effect of bilateral ESPB on early postoperative pain and opioid use after lumbar spinal fusion surgery.

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Randomized prospective study comparing Exparel® Erector

The purpose of this study is to determine the effectiveness of Erector Spinae Plane Block (ESP) versus surgeon infiltration for postoperative analgesic control ...

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Effects of erector spinae plane block on intraoperative ...

Additionally, ESPB significantly decreased postoperative pain, particularly immediately after surgery and on the first postoperative day, while ...

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This meta-analysis demonstrated that ESPB used in lumbar spinal surgery was effective in relieving postoperative pain, decreasing the perioperative consumption ...

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clinicaltrials.gov

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Erector Spinae Plane (ESP) Block Volunteer Study

The goal of this study is to determine the extent and duration of clinical neural blockade following an ESP injection with different local anesthetic doses.

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sciencedirect.com

sciencedirect.com/science/article/pii/S0736467925003737

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In the perioperative setting, anesthesiologists have widely adopted the ESPB to reduce pain and opioid requirements following hernia repair, ...

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NCT06528288 | Effects of Erector Spinae Plane Block on ...

The investigators hypothesize that patients who get ESPB injections will use less opioids and report less pain after lumbar fusion surgery compared to patients ...