Nerve Block for Pain Management

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

40 Participants Needed

Trial Summary

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 drug Bupivacaine Injection, including its formulations like Exparel, for pain management?

Research shows that liposomal bupivacaine (Exparel) can provide extended pain relief after surgery, but its effectiveness compared to standard bupivacaine is mixed. Some studies found it less effective than regular bupivacaine for nerve blocks, while others noted potential benefits in reducing pain and opioid use after certain surgeries. ^{1 2 3 4 5}

Is liposomal bupivacaine (Exparel) safe for use in nerve blocks?

Liposomal bupivacaine (Exparel) has been shown to be safe in clinical trials for use in peripheral nerve blocks and other procedures, with minimal side effects when used as directed. It is approved for use in surgical sites to manage pain, and studies suggest it has a good safety profile. ^{2 3 6 7 8}

How is the drug Bupivacaine Injection unique for pain management?

Bupivacaine Injection, particularly in its liposomal form (Exparel), is unique because it is designed to provide extended pain relief by slowly releasing the anesthetic over time, which can reduce the need for additional pain medications like opioids. This formulation is particularly used for managing pain after surgery and has been explored for off-label use in peripheral nerve blocks. ^{2 3 8 9 10}

What is the purpose of this trial?

Interventional study to use erector spinae plane block (ESPB) on diagnoses of posterior or lateral rib fractures, vertebral fractures, pancreatitis, pancreatic cancer, renal colic, and back pain for multimodal pain therapy to determine its assistance with pain relief as well as the patient's use of opiates after block completion

Research Team

Morgan Ritz, MD

Principal Investigator

University of Texas Health Science Center San Antonio

Eligibility Criteria

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 severe kidney pain.

I am experiencing back pain.

I have had fractures in my ribs or spine.

Exclusion Criteria

My vital signs are not stable.

I am under 18 years old.

Prior allergic reaction to local anesthetic

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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]

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]

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]

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 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]

References

1. United States 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. [2017]

2. Germany 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. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. [2022]

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

Clinical Effectiveness of Liposomal Bupivacaine Administered by Infiltration or Peripheral Nerve Block to Treat Postoperative Pain. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Perineural dexamethasone attenuates liposomal bupivacaine-induced delayed neural inflammation in mice in vivo. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Bupivacaine Versus Liposomal Bupivacaine for Postoperative Pain Control after Augmentation Mammaplasty: A Prospective, Randomized, Double-Blind Trial. [2022]

7. France pubmed.ncbi.nlm.nih.gov

[The use of Marcaine in obstetrical analgesia]. [2013]

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

Treatment of digital ischemia with liposomal bupivacaine. [2021]

9. Serbia pubmed.ncbi.nlm.nih.gov

Clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor in oral implantology. [2019]

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

Perineural Liposomal Bupivacaine Is Not Superior to Nonliposomal Bupivacaine for Peripheral Nerve Block Analgesia. [2021]