Local Anesthetic + Education for Carpal Tunnel Syndrome

Overseen By Ronald Buczek, DO

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Kettering Health Network

Must not be taking: Opioids, Tricyclic antidepressants

Disqualifiers: Bupivacaine allergy, Percocet allergy, 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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 1 day

64 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to manage pain after carpal tunnel surgery without using opioids (strong painkillers). The experimental group receives a long-acting anesthetic called Exparel (bupivacaine liposome injectable suspension) and education about opioids, while the control group follows the usual method with bupivacaine and may require opioids. The goal is to determine if Exparel can effectively manage pain and reduce opioid use. Individuals diagnosed with carpal tunnel syndrome who haven't recently used opioids may find this trial suitable. As a Phase 4 trial, this research focuses on understanding how this FDA-approved treatment can benefit more patients.

Will I have to stop taking my current medications?

If you are taking tricyclic antidepressants, you will need to stop because they interact with the medication used in the trial. For other medications, the trial protocol does not specify whether you need to stop taking them.

What is the safety track record for Exparel?

Research has shown that Exparel, a long-lasting local pain reliever, is generally safe. Studies identified nausea and a reduced sense of touch as the most common side effects. Serious side effects occurred in about 8% of participants. While Exparel is mostly well-tolerated, some risks exist, as with any treatment. Notably, the FDA has already approved Exparel for other uses, which supports its safety profile. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Exparel for carpal tunnel syndrome because it offers a non-opioid alternative for managing pain. Unlike the standard care, which typically involves bupivacaine injections followed by opioid prescriptions, Exparel combines liposomal bupivacaine with bupivacaine and epinephrine for prolonged pain relief without the need for opioids. This innovative approach reduces the risk of opioid dependency and aims to provide effective pain control with less medication. By focusing on local pain management, Exparel could revolutionize how post-surgical pain for carpal tunnel syndrome is treated, making recovery safer and more comfortable.

What evidence suggests that this trial's treatments could be effective for carpal tunnel syndrome?

Research has shown that Exparel, a long-lasting pain reliever, effectively reduces pain after surgery. It can provide relief for up to 72 hours, surpassing the duration of the usual pain medicine, bupivacaine. This trial will compare two approaches: one group will receive Exparel without opioids, while the control group will receive bupivacaine with opioids. The aim is to assess Exparel's effectiveness in lowering the need for opioids, which are strong and potentially addictive painkillers. Studies have also found Exparel to be safe, making it a reliable choice for managing post-surgical pain. Overall, Exparel could offer a promising way to manage pain after carpal tunnel surgery without relying on opioids. ^{1 2 3 6 7}

Who Is on the Research Team?

Ronald Buczek, DO

Principal Investigator

Kettering Health Network

Are You a Good Fit for This Trial?

This trial is for adults over 18 with diagnosed carpal tunnel syndrome who haven't used opioids in the last six months. It's not for those allergic to bupivacaine or Percocet, taking tricyclic antidepressants, or are pregnant or prisoners.

Inclusion Criteria

I am older than 18 years.

I have been diagnosed with carpal tunnel syndrome.

I am older than 18 years.

Exclusion Criteria

You are allergic to Percocet or acetaminophen.

I am currently taking tricyclic antidepressants.

I have used opioids in the last 6 months before surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pre-operative opioid education and either Exparel injection or standard bupivacaine with opioids for pain management during carpal tunnel surgery

1 day

1 visit (in-person)

Post-operative Monitoring

Pain scores and medication usage are tracked for three days post-operatively to assess the efficacy of pain management strategies

3 days

3 follow-ups (telephone or email)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exparel

Trial Overview The study tests if Exparel combined with opioid education can prevent post-surgery opioid use after carpal tunnel release compared to standard treatment using non-liposomal bupivacaine plus opioids.

How Is the Trial Designed?

Group I: Experimental Group: Exparel, no opioids Experimental Treatment 1 Intervention

This group will receive pre-operative opioid education, Exparel injection (liposomal bupivacaine, with bupivacaine, epinephrine and bicarbonate), and would not receive a prescription for opioids. This injection will be administered as 10cc injected in the operative field, consisting of \~5cc of Exparel (liposomal bupivacaine), \~5cc of bupivacaine, and \~1cc epinephrine. Pain scores and medication usage will be tracked for three days post operatively to assess the validity and efficacy of differing pain management strategies.

Group II: Control Group; Bupivacaine + opioids Active Control 1 Intervention

This is the "standard of care" arm. This group will receive pre-operative opioid education and "standard of care", which consists of an injection of 10cc bupivacaine (plus \~1cc epinephrine and bicarbonate) into the carpal tunnel and overlying skin pre-operatively, and a post operative prescription for opioids (oxycodone/acetaminophen 5/325). Pain scores and medication usage will be tracked for three days post operatively to assess the validity and efficacy of differing pain management strategies.

Exparel is already approved in United States for the following indications:

Approved in United States as Exparel for:

• Postsurgical local analgesia via infiltration in patients aged 6 years and older
• Postsurgical regional analgesia via an interscalene brachial plexus block in adults
• Postsurgical regional analgesia via a sciatic nerve block in the popliteal fossa in adults
• Postsurgical regional analgesia via an adductor canal block in adults

Who Is Running the Clinical Trial?

Kettering Health Network

Lead Sponsor

Trials

20

Recruited

1,700+

American Society for Surgery of the Hand

Collaborator

Trials

11

Recruited

1,100+

Published Research Related to This Trial

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]

In a study involving 59 patients undergoing total knee arthroplasty, liposomal bupivacaine did not show a significant clinical advantage over standard bupivacaine in terms of postoperative recovery, as measured by the number of physical therapy sessions needed for discharge.

The use of liposomal bupivacaine was associated with higher medication charges, raising concerns about its cost-effectiveness compared to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liposomal Bupivacaine Versus Standard Periarticular Injection in Total Knee Arthroplasty With Regional Anesthesia: A Prospective Randomized Controlled Trial. Hyland, SJ., Deliberato, DG., Fada, RA., et al.[2019]

In a pilot study involving 25 pigs, subarachnoid administration of liposomal bupivacaine resulted in a longer duration of pain relief compared to standard bupivacaine hydrochloride, with effects lasting up to 32 hours for higher doses.

No signs of neurotoxicity were observed in any treatment group, suggesting that liposomal bupivacaine may be a safe option for extended analgesia in the neuraxial space, warranting further studies for potential human use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurological and histological outcomes after subarachnoid injection of a liposomal bupivacaine suspension in pigs: a pilot study. Zel, J., Hadzic, A., Cvetko, E., et al.[2019]

EXPAREL® (bupivacaine liposome injectable suspension) is an effective extended-release local anesthetic that can significantly improve postoperative pain management in orthopedic trauma surgery, as demonstrated in two case studies.

Both patients treated with EXPAREL® experienced good control of postsurgical pain, highlighting its safety and efficacy as part of a multimodal analgesia approach in reducing the risk of chronic pain after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local infiltration of liposome bupivacaine in orthopedic trauma patients: case-based reviews. Hutchinson, HL.[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]

Exparel™ (DepoFoam bupivacaine) provides a longer-lasting nerve blockade (240 minutes) compared to standard bupivacaine solutions, which lasted 120 minutes and 210 minutes, indicating its potential for improved pain management.

While Exparel™ showed slightly higher inflammation scores than standard bupivacaine solutions shortly after injection, it had similar myotoxicity levels and no neurotoxicity, suggesting it may be a safe option for local anesthesia, though monitoring for tissue reactions is recommended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multivesicular liposomal bupivacaine at the sciatic nerve. McAlvin, JB., Padera, RF., Shankarappa, SA., et al.[2022]

Liposomal bupivacaine (LB) is safe for use in pediatric patients and significantly improves pain control after pharyngoplasty, as evidenced by lower pain scores compared to those receiving standard lidocaine.

Patients treated with LB had earlier oral intake, required fewer opioids, and were discharged from the hospital nearly 2 days earlier than those in the control group, highlighting its efficacy in postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended Release Liposomal Bupivacaine Injection (Exparel) for Early Postoperative Pain Control Following Pharyngoplasty. Day, KM., Nair, NM., Griner, D., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03867539

Exparel and Education to Avoid Opioids After Carpal ... This trial seeks to use the long acting local anesthetic Exparel, in conjunction with opioid education, to attempt to avoid any post-operative opioid use ...

2. withpower.com withpower.com/trial/phase-4-carpal-tunnel-syndrome-1-2019-f919f

Local Anesthetic + Education for Carpal Tunnel Syndrome In a study involving 98 mice, liposomal bupivacaine (Exparel®) provided a longer duration of pain relief compared to standard bupivacaine, with motor block ...

3. aging.networkofcare.org aging.networkofcare.org/riverside/CommunityResources/ClinicalTrials/Detail/NCT02141178?keyword=%22Carpal%20Tunnel%20Release%22

Comparison of Bupivacaine and Exparel for Carpal Tunnel ... Exparel, a liposomal bupivicaine formulation, has been documented to provide pain relief for up to 72 hours post-operatively. By decreasing post-operative pain ...

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/60/NCT05005260/Prot_SAP_000.pdf

Prospective, randomized clinical trial comparing analgesic ... EXPAREL (bupivacaine liposome injectable suspension) [prescribing information]. Parsippany, NJ: Pacira Pharmaceuticals, Inc; 2016. http ...

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

Bupivacaine Liposome (Exparel) - Medical Clinical Policy ... Studies have shown it to be an effective tool for postoperative pain relief with opioid sparing effects and it has also been found to have an acceptable adverse ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4174079/

Update/Review: Changing of Use of Local Anesthesia in ... There is level I evidence that pain relief in digital blocks with bupivacaine lasts only half as long (15 hours) as the return to normal sensation (30 hours).

7. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/538335

Exparel and Education to Avoid Opioids After Carpal ... This trial seeks to use the long acting local anesthetic Exparel, in conjunction with opioid education, to attempt to avoid any post-operative opioid use ...