Nerve Block vs Local Anesthetic for Postoperative Pain

Overseen By Rashmi Mueller, MD

Age: 18+

Sex: Any

Trial Phase: Academic

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)

Compensation: Varies

Number of Visits: 5

Duration: 1 day

120 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Erector Spinae Block for postoperative pain?

Research shows that the erector spinae plane block can effectively reduce pain after lumbar spinal surgery, as it has been compared favorably to wound infiltration and shown to improve pain relief in various studies. ^{1 2 3 4 5}

Is the Erector Spinae Plane (ESP) Block safe for humans?

The available research does not specifically address the safety of the Erector Spinae Plane (ESP) Block, but it is a widely used technique for managing pain after surgery, suggesting it is generally considered safe in clinical practice. ^{1 4 6 7 8}

How does the erector spinae plane block treatment differ from other treatments for postoperative pain?

The erector spinae plane block is a novel regional anesthesia technique that involves injecting a local anesthetic near the spine to block pain signals. Unlike traditional methods, it targets the origin of spinal nerves and can be used for a wide range of surgeries, offering a potentially safer and more effective alternative for managing postoperative pain. ^{2 5 6 9 10}

What is the purpose of this trial?

The proposed intervention will examine two alternative methods for postoperative pain control. Two treatment arms of this study will include subjects who receive an erector spinae block (ESP) after induction of anesthesia but prior to the start of surgery and subjects who will receive a high volume of local anesthetic infiltration at the end of the procedure before emergence from anesthesia. The control group of subjects will undergo spinal surgery with general anesthesia but without any regional anesthesia. Outcome measurements include evaluation of serum inflammatory markers, pain scores, opioid usage and standardized evidence-based assessment methodologies.

Research Team

Rashmi Mueller, MD

Principal Investigator

University of Iowa

Eligibility Criteria

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.

I do not have major liver, kidney, or other organ problems.

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

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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 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 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]

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]

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 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]

References

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

Efficacy of erector spinae plane block for postoperative analgesia lumbar surgery: a systematic review and meta-analysis. [2023]

2. Germany 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. [2023]

3. 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]

4. England pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of lidocaine after bilateral ESP block. [2021]

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

Bilateral Erector Spinae Plane Block for Surgery on the Posterior Aspect of the Neck: A Case Report. [2021]

6. 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]

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

Evaluation of Sensory Mapping of Erector Spinae Plane Block. [2020]

8. Italy pubmed.ncbi.nlm.nih.gov

Erector spinae plane block: a systematic qualitative review. [2022]

9. 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]

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

Ultrasound-guided Low Thoracic Erector Spinae Plane Block for Effective Postoperative Analgesia after Lumbar Surgery: Report of Five Cases. [2020]