ESP Block for Post-Surgery Pain

Recruiting in Palo Alto (17 mi)

Overseen by Michael Dinsmore, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University Health Network, Toronto

Disqualifiers: Allergy to anesthetics, Pregnancy, others

Trial Summary

What is the purpose of this trial?

Patients undergoing spine surgery frequently experience significant pain after surgery. This can limit patient activity and hinder rehabilitation. If inadequately treated, severe pain can result in emotional and psychological distress and ultimately impact long-term function, and increase the risk of developing pain that lasts longer than six months associated with depression, anxiety and disability. More specifically, Erector Spinae Plane (ESP) block is a recently described plane block designed to block the dorsal and ventral rami of the thoracic spinal nerves. It has shown to be an effective modality for postoperative pain management as a part of multimodal analgesia in spinal surgery.

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 (ESP) Block for post-surgery pain?

Research shows that the Erector Spinae Plane (ESP) block is effective in managing post-surgery pain, as it provides significant pain relief and reduces the need for opioids after surgeries, such as spinal cord stimulation implants and various abdominal surgeries. ^{1 2 3 4 5}

Is the ESP Block generally safe for humans?

The ESP Block is generally considered safe, but there have been reports of complications, such as priapism (a prolonged and painful erection) in some cases. As with any medical procedure, the risk of side effects may increase with more frequent use. ^{1 4 6 7 8}

How does the ESP block treatment differ from other treatments for post-surgery pain?

The ESP block is unique because it involves injecting a local anesthetic near the spine to block pain signals, offering effective pain relief with potentially fewer side effects than traditional methods like IV morphine. It is a relatively new technique that can be used for both acute and chronic pain, and it may reduce the need for opioids after surgery. ^{1 3 4 9 10}

Research Team

Michael Dinsmore, MD

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

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.

Inclusion Criteria

I am between 18-80 years old and need surgery for neck narrowing.

Exclusion Criteria

My cancer is located in the cervical spine area.

Pregnant patient

Lack of informed consent

Trial Timeline

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)

Treatment Details

Interventions

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

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.

Participant Groups

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+

Dr. Brad Wouters

University Health Network, Toronto

Chief Medical Officer since 2020

MD from University of Toronto

Dr. Kevin Smith

University Health Network, Toronto

Chief Executive Officer since 2018

Professor at McMaster University and University of Toronto

Findings from Research

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 (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]

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 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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of lidocaine after bilateral ESP block. [2021]

2. India pubmed.ncbi.nlm.nih.gov

Erector spinae plane block in various abdominal surgeries: A case series. [2021]

3. India pubmed.ncbi.nlm.nih.gov

Erector spinae plane block: Relatively new block on horizon with a wide spectrum of application - A case series. [2020]

4. England 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Anatomical evaluation of the extent of spread in the erector spinae plane block: a cadaveric study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Priapism following erector spinae plane block for the treatment of a complex regional pain syndrome. [2019]

7. Spain pubmed.ncbi.nlm.nih.gov

Erector spinae plane block: A cadaver study to determine its mechanism of action. [2022]

8. England 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Erector spinae plane block and thoracic paravertebral block for breast surgery compared to IV-morphine: A randomized controlled trial. [2021]

10. Switzerland 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. [2023]