Nerve Block vs Local Anesthetic for Postoperative Pain

Overseen By Rashmi Mueller, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Rashmi Mueller

Must not be taking: Opioids

Disqualifiers: Organ dysfunction, Chronic pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods for managing pain after spinal surgery. One group receives an erector spinae block, a type of regional anesthesia administered before surgery, while another group receives a large dose of local anesthetic (local infiltration) at the end of surgery. A control group receives only standard general anesthesia without additional pain control methods. The trial seeks participants with planned spinal fusion surgery who do not regularly use opioids and have no major organ problems. The goal is to determine which method more effectively reduces pain, inflammation, and opioid use after surgery. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance pain management strategies for future patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are opioid tolerant or have narcotic dependence, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the Erector Spinae Block (ESP) effectively manages post-surgical pain. Studies indicate that ESP blocks reduce pain and lessen the need for additional pain medications. They are easy to perform and generally well-tolerated, with no major safety issues reported. However, further research is needed to enhance consistency and ensure proper safety checks.

Similarly, studies on Local Infiltration (LIA) demonstrate its safety and effectiveness in controlling post-surgical pain. LIA often provides better pain relief and fewer side effects compared to methods like epidural pain relief. Both treatments are generally well-tolerated and have shown positive results in managing pain with minimal side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about comparing nerve blocks and local anesthetics for postoperative pain because these techniques offer potentially improved pain management over traditional opioid use. The Erector Spinae Block (ESP) is unique as it provides regional anesthesia by targeting specific nerves around the spine, which can offer longer-lasting pain relief and potentially fewer side effects than systemic painkillers. Local infiltration, on the other hand, involves directly applying anesthetic to the surgical site, which can be more precise and reduce the need for systemic medications. Both methods aim to enhance recovery by minimizing reliance on opioids, reducing pain, and improving patient comfort post-surgery.

What evidence suggests that this trial's treatments could be effective for postoperative pain?

This trial will compare the effectiveness of the Erector Spinae Block (ESP) and Local Infiltration for managing postoperative pain. Research has shown that the Erector Spinae Block significantly reduces pain and the need for opioids, and it is considered safe and easy to perform. Meanwhile, studies on the Local Infiltration technique indicate it lessens early postoperative pain and overall narcotic use, proving effective in various surgeries by lowering pain levels and reducing the need for additional pain medication. Both methods show promise for controlling pain after surgery. ^{1 6 7 8 9}

Who Is on the Research Team?

Rashmi Mueller, MD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 who have not regularly used opioids (less than the equivalent of 6 oxycodone pills per day), are undergoing a planned non-emergency spinal fusion surgery between T8 and S2, and have no allergies or conditions that would prevent them from receiving local anesthetics or regional anesthesia procedures.

Inclusion Criteria

I am not allergic to local anesthetics.

I take less than 6 oxycodone pills a day or its equivalent.

I am between 19 and 79 years old.

Exclusion Criteria

I have had emergency surgery.

Significant psychiatric illnesses that impedes the subject's ability to provide informed consent

Vulnerable population (e.g. prisoners)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Pre-procedure

Pre-procedure activities include survey evaluations and baseline evaluations such as social history, pain medication history, and pain rating

1 day

1 visit (in-person)

Treatment

Participants undergo thoraco-lumbar fusion surgery with different anesthesia protocols: ESP block, LIA, or GA only

1 day

1 visit (in-person)

Post-operative Monitoring

Pain control and opioid usage are monitored for the first 72 hours post-surgery, with survey evaluations during the first 7 days of hospital stay

7 days

Daily monitoring (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of delirium symptoms up to 3 days post-operation

3 days

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Erector Spinae Block
• Local Infiltration

Trial Overview

The study compares two pain control methods after spinal surgery: one group receives an erector spinae block before surgery, another gets local anesthetic infiltration at the end of surgery, and a control group has general anesthesia without regional anesthesia. Pain levels, inflammation markers, opioid use, and recovery assessments will be measured.

How Is the Trial Designed?

Group I: Group GA: General anesthesia only Active Control 1 Intervention

This group receives general anesthesia only and surgical procedure will follow standard conditions.

Group II: Group ESP: Erector Spinae Block Active Control 1 Intervention

This group receives general anesthesia with regional pain block (Erector Spinae Block) prior to incision.

Group III: Group LIA: Local Infiltration Active Control 1 Intervention

This group receives general anesthesia and surgical procedure will take place as planned. Prior to being awakened, the area of procedure will be infiltrated.

Who Is Running the Clinical Trial?

Rashmi Mueller

Lead Sponsor

Trials

1

Recruited

120+

Published Research Related to This Trial

In a study of 60 patients undergoing lumbar spinal fusion surgery, those who received a bilateral erector spinae plane block used significantly less opioid medication (median 11 μg) compared to those who had wound infiltration (median 20 μg) within the first 24 hours post-surgery.

Both methods provided similar pain relief, but the erector spinae plane block resulted in fewer patients needing additional rescue analgesia within 48 hours, and no adverse events were reported, indicating it is a safe and effective option for postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral ultrasound-guided erector spinae plane block versus wound infiltration for postoperative analgesia in lumbar spinal fusion surgery: a randomized controlled trial. Zhang, Z., Zhu, RL., Yue, L., et al.[2023]

The erector spinae plane (ESP) block is a promising technique for managing chronic thoracic pain, showing benefits such as reduced opioid use and longer time to first analgesic requirement, based on a qualitative review of four randomized controlled trials.

While the ESP block appears to be safe and effective, with some studies suggesting it can be as effective as epidural analgesia, further well-designed randomized controlled trials are necessary to fully understand its safety and efficacy compared to standard regional anesthesia techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Erector spinae plane block: a systematic qualitative review. De Cassai, A., Bonvicini, D., Correale, C., et al.[2022]

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 study found that an ultrasound-guided erector spinae plane (ESP) block using 20 mL of 0.5% bupivacaine resulted in a mean dermatomal spread of 9 dermatomes, effectively providing pain relief for patients with acute thoracic pain.

Sixteen out of eighteen patients experienced significant pain relief, with Visual Analog Scale (VAS) scores improving by at least 50% and high patient satisfaction reported, indicating the ESP block is both effective and safe with no major complications observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Sensory Mapping of Erector Spinae Plane Block. Barrios, A., Camelo, J., Gomez, J., et al.[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 (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]

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]

The erector spinae plane (ESP) block significantly reduces opioid consumption and pain scores in the first 24 hours after lumbar surgery, based on a meta-analysis of 11 studies with 775 patients.

Patients receiving the ESP block also experienced a longer time before needing their first analgesic and had lower rates of postoperative nausea and vomiting (PONV) compared to those who did not receive the block.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of erector spinae plane block for postoperative analgesia lumbar surgery: a systematic review and meta-analysis. Sun, Q., Zhang, C., Liu, S., et al.[2023]

The erector spinae plane block is a technique where local anesthetic is injected to provide pain relief in various regions, including thoracic, abdominal, and lumbar areas.

This study reports the first successful use of a bilateral erector spinae plane block for surgical anesthesia in the cervical region, expanding its potential applications in anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral Erector Spinae Plane Block for Surgery on the Posterior Aspect of the Neck: A Case Report. Evans, HT., Leslie, GJ., Rutka, O., et al.[2021]

The Erector Spinae Plane (ESP) block is a promising new technique for providing effective postoperative pain relief after lumbar spinal surgery, as demonstrated in a case series of five patients.

This technique blocks both sensory and sympathetic nerve fibers, suggesting it could be a valuable part of multimodal analgesia strategies, although further prospective studies are needed to fully assess its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided Low Thoracic Erector Spinae Plane Block for Effective Postoperative Analgesia after Lumbar Surgery: Report of Five Cases. Cesur, S., Yayik, AM., Ozturk, F., et al.[2020]

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