Nerve Block for Pain Management

No longer recruiting at 3 trial locations

Overseen By Morgan Ritz, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: The University of Texas Health Science Center at San Antonio

Disqualifiers: Unstable vitals, Infection, Pregnancy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 30 minutes

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively a nerve block using a bupivacaine injection can relieve pain and reduce the need for opiates in patients with specific conditions. These conditions include broken ribs or vertebrae, pancreatitis, pancreatic cancer, kidney stone pain, or general back pain. Participants will receive the nerve block under ultrasound guidance to precisely target the pain source. Individuals dealing with any of these painful conditions and seeking new pain management options may find this trial suitable. As an Early Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to explore this new pain management option.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that bupivacaine, used in nerve blocks for pain relief, is generally safe. One study examined a mix of liposomal bupivacaine and regular bupivacaine for nerve blocks and found it safe and effective.

Although specific side effects weren't detailed, bupivacaine is a well-known local anesthetic studied in many situations. It often manages pain during and after surgeries, suggesting it is usually well-tolerated. However, since this trial is in an early stage, researchers are still carefully checking the treatment for safety in humans.

Prospective participants should discuss any concerns with the trial team, who can provide more details on what to expect. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard pain management options that often rely on oral medications or invasive procedures, the use of a bupivacaine injection for an Erector Spinae Plane Block (ESP) stands out due to its targeted and minimally invasive approach. This treatment is administered under ultrasound guidance, which enhances precision and reduces the risk of complications. By directly delivering the anesthetic near the nerves responsible for pain, it can provide more effective and immediate relief. Researchers are excited because this method has the potential to offer better pain control with fewer side effects compared to traditional systemic pain medications.

What evidence suggests that the erector spinae plane block is effective for pain management?

Research has shown that bupivacaine injections can help manage pain. In this trial, participants will receive bupivacaine through a technique called the erector spinae plane block (ESPB). Some studies found that this method provided longer-lasting pain relief and reduced the need for opioid painkillers, allowing patients to experience less pain for extended periods without relying on strong medications. Early findings suggest that bupivacaine injections can effectively contribute to a pain relief plan for conditions like rib fractures and pancreatitis. Overall, this treatment appears promising for managing pain and aiding recovery. ^{3 4 6 7 8}

Who Is on the Research Team?

Morgan Ritz, MD

Principal Investigator

University of Texas Health Science Center San Antonio

Are You a Good Fit for This Trial?

This trial is for adults with certain painful conditions like rib or vertebral fractures, pancreatitis, pancreatic cancer, renal colic, and back pain. It's not suitable for those with unstable vital signs, skin infections at the injection site, allergies to local anesthetics, pregnant women or individuals under 18.

Inclusion Criteria

I have had fractures in my ribs or spine.

I am experiencing back pain.

I have had severe kidney pain.

Exclusion Criteria

My vital signs are not stable.

I am under 18 years old.

Prior allergic reaction to local anesthetic

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive an erector spinae plane block (ESPB) under ultrasound guidance for pain control

30 minutes

1 visit (in-person)

Follow-up

Participants are monitored for pain relief and opiate use after the procedure

8 hours

What Are the Treatments Tested in This Trial?

Interventions

• Bupivacaine Injection

Trial Overview

The study tests if injecting Bupivacaine into the erector spinae muscles can help manage pain from specific conditions and reduce the need for opioid painkillers after treatment.

How Is the Trial Designed?

Group I: Erector Spinae Plane Block (ESP) administration Experimental Treatment 1 Intervention

Patients with the listed diagnoses will be offered and then consented for an ESPB under ultrasound guidance.

Bupivacaine Injection is already approved in United States, European Union for the following indications:

Approved in United States as Marcaine for:

• Local Anesthesia
• Postoperative Pain
• Cesarean Section
• Epidural Anesthesia
• Caudal Blocks
• Sympathetic Nerve Block
• Peripheral Nerve Block

Approved in European Union as Sensorcaine for:

• Local Anesthesia
• Regional Anesthesia
• Pain Management

Approved in United States as Posimir for:

• Post-surgical Analgesia for up to 72 hours following arthroscopic subacromial decompression

Approved in United States as Xaracoll for:

• Acute postsurgical analgesia for up to 24 hours in adults following open inguinal hernia repair

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

Published Research Related to This Trial

A 45-year-old woman with severe digital ischemic pain showed marked improvement after receiving an axillary nerve block with liposomal bupivacaine (Exparel), suggesting its potential role in managing vasoocclusive symptoms despite being used off-label.

This case highlights the analgesic properties of liposomal bupivacaine in a patient who was not a candidate for surgical interventions, indicating that it may provide significant pain relief in similar cases of ischemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of digital ischemia with liposomal bupivacaine. Soberón, JR., Duncan, SF., Sternbergh, WC.[2021]

Bupivacaine (Marcaine) is effective for epidural analgesia in obstetrics, providing excellent sensory block with minimal impact on motor function and few side effects for both mothers and newborns.

When used at concentrations below 0.5%, and with careful dosing during labor, the risk of side effects and toxicity is low, and significant effects on newborns are rare due to the drug's high protein binding limiting its transfer across the placenta.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of Marcaine in obstetrical analgesia]. Seebacher, J., Chareire, F., Galli-Douant, P., et al.[2013]

In a study of 20 patients undergoing lingual nerve microsurgery, those who received liposomal bupivacaine (LB) reported significantly less postoperative pain and consumed fewer opioid pills compared to those who received bupivacaine hydrochloride (BH).

The findings suggest that LB, with its prolonged duration of action, is more effective in reducing postoperative pain and opioid consumption, supporting its use in surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liposomal bupivacaine use in exploratory lingual nerve microsurgery: does liposomal bupivacaine use decrease postoperative pain and opioid consumption compared to bupivacaine hydrochloride? A pilot study. Jacobus, D., Mehr, S., Ziccardi, V.[2021]

Bupivacaine with a vasoconstrictor has a shorter onset time for local anesthesia compared to bupivacaine without a vasoconstrictor, but the duration of anesthesia is longer without the vasoconstrictor.

Using bupivacaine without a vasoconstrictor resulted in lower postoperative pain levels and better blood circulation, which is beneficial for the osseointegration of dental implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor in oral implantology. Duka, M., Lazić, Z., Stamatović, N., et al.[2019]

A meta-analysis of nine trials involving 619 patients found that perineural liposomal bupivacaine provided a statistically significant but clinically unimportant improvement in pain scores compared to nonliposomal bupivacaine, with only a 1.0 cm·h difference in pain severity.

Excluding an industry-sponsored trial made the difference between liposomal and nonliposomal bupivacaine nonsignificant, indicating that there is no substantial evidence to support the use of liposomal bupivacaine over traditional local anesthetics for peripheral nerve blocks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perineural Liposomal Bupivacaine Is Not Superior to Nonliposomal Bupivacaine for Peripheral Nerve Block Analgesia. Hussain, N., Brull, R., Sheehy, B., et al.[2021]

In a study involving 100 patients with pulpal necrosis, liposomal bupivacaine did not show a statistically significant improvement in postoperative pain relief compared to standard bupivacaine, with success rates of 29% and 22% respectively.

While liposomal bupivacaine had some effects on soft tissue numbness and non-narcotic medication use, these effects were not clinically significant, indicating that it may not provide additional benefits over traditional bupivacaine for postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Liposomal Bupivacaine (Exparel) Significantly Reduce Postoperative Pain/Numbness in Symptomatic Teeth with a Diagnosis of Necrosis? A Prospective, Randomized, Double-blind Trial. Glenn, B., Drum, M., Reader, A., et al.[2017]

In a study of 34 patients undergoing breast augmentation, liposomal bupivacaine provided statistically significant lower pain scores compared to standard bupivacaine at multiple time points post-surgery, indicating it may offer better pain control.

Despite the statistical significance, the differences in pain relief were small, and 70% of patients felt the additional cost of liposomal bupivacaine was not justified by the benefits, suggesting limited clinical relevance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupivacaine Versus Liposomal Bupivacaine for Postoperative Pain Control after Augmentation Mammaplasty: A Prospective, Randomized, Double-Blind Trial. Nadeau, MH., Saraswat, A., Vasko, A., et al.[2022]

In a study involving 98 mice, liposomal bupivacaine (Exparel®) provided a longer duration of pain relief compared to standard bupivacaine, with motor block lasting up to 180 minutes and thermoalgesic block lasting up to 420 minutes.

The addition of dexamethasone, either perineurally or systemically, significantly reduced neural inflammation caused by bupivacaine, and perineural dexamethasone also helped reduce inflammation from Exparel®, suggesting a protective effect against nerve damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perineural dexamethasone attenuates liposomal bupivacaine-induced delayed neural inflammation in mice in vivo. Ferré, F., Krin, A., Sanchez, M., et al.[2020]

A review of 76 randomized controlled trials found that only 11% showed a significant benefit of liposomal bupivacaine over standard bupivacaine or ropivacaine for postoperative pain control.

The majority of trials indicated that unencapsulated bupivacaine provided better pain relief than liposomal bupivacaine, suggesting that routine use of liposomal bupivacaine may not be justified based on current evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Effectiveness of Liposomal Bupivacaine Administered by Infiltration or Peripheral Nerve Block to Treat Postoperative Pain. Ilfeld, BM., Eisenach, JC., Gabriel, RA.[2021]

In a retrospective analysis of 575 subjects across 6 clinical trials, liposome bupivacaine showed a similar safety profile to both bupivacaine HCl and normal saline, with 76% of liposome bupivacaine recipients experiencing adverse events (AEs).

The most common AEs for liposome bupivacaine included nausea and hypesthesia, and serious AEs occurred in 8% of subjects, indicating that the side effects are likely related to the surgical procedure rather than the medication itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. Ilfeld, BM., Viscusi, ER., Hadzic, A., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11994616/

Comparison of the analgesic effects of liposomal ...

This study aims to evaluate the analgesic efficacy of anesthesiologist-performed ESPB using LB versus surgeon-administrated ICNB with LB in patients undergoing ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06252662

Study Details | NCT06252662 | Liposomal Bupivacaine Vs ...

Performance of a single-blinded randomized control trial to evaluate effectiveness of postoperative pain control in erector spinae plane blocks with bupivacaine ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0022480423001178

Erector Spinae Plane Block With Liposomal Bupivacaine

ESPB with liposomal bupivacaine may be considered as an analgesic adjunct to enhance recovery in patients undergoing cardiothoracic procedures.

4.

eurjmedres.biomedcentral.com

eurjmedres.biomedcentral.com/articles/10.1186/s40001-025-03174-2

Comparison of liposomal bupivacaine erector spinae plane ...

In a recent randomized controlled trial [11], ESPB significantly prolonged the duration of analgesia and reduced opioid consumption. Therefore, ...

5.

frontiersin.org

frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1359878/full

Effect of liposomal bupivacaine for preoperative erector ...

This study aims to determine the effect of LB versus bupivacaine hydrochloride (HCl) for preoperative ultrasound-guided erector spinae plane block (ESPB) on ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10158925/

Clinical Outcomes of Liposomal Bupivacaine Erector ...

Liposomal bupivacaine (LB) has been shown to decrease postoperative pain and narcotic consumption after transforaminal lumbar interbody fusions ...

7.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/47/NCT04559347/SAP_001.pdf

Statistical Analysis Plan

The objectives of this study are to assess the efficacy of the erector spinae nerve block using Single. Shot Liposomal Bupivacaine (EXPAREL®)/ ...

8.

aetna.com

aetna.com/cpb/medical/data/900_999/0941.html

Bupivacaine Liposome (Exparel) - Medical Clinical Policy ...

Although at 48 hours, 9 subjects (13%) in the Exparel group remained opioid-free compared to 1 subject (1%) in the placebo group, a difference which was ...