64 Participants Needed

Local Anesthetic + Education for Carpal Tunnel Syndrome

RB
Overseen ByRonald Buczek, DO
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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 following carpal tunnel surgery. This group will be compared with a "standard" group that receives non-liposomal bupivacaine, opioid education, and opioids.

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.

Is liposomal bupivacaine (Exparel) safe for use in humans?

Liposomal bupivacaine (Exparel) has been studied for safety in various uses, showing some inflammation and tissue reaction similar to other bupivacaine solutions, but no nerve damage was detected. It is generally considered safe for use in humans, but monitoring for local tissue injury is important.12345

What makes Exparel unique for treating carpal tunnel syndrome?

Exparel is unique because it is a long-acting local anesthetic that uses a special liposomal formulation to release bupivacaine slowly over time, providing extended pain relief after surgery. This is different from standard treatments that may require more frequent dosing or additional pain medications.12567

What data supports the effectiveness of the drug Exparel for treating carpal tunnel syndrome?

Exparel, a long-acting local anesthetic, has been shown to reduce postoperative pain and the need for opioids in other surgeries, like knee replacements and pharyngoplasty, suggesting it might help with pain management in carpal tunnel syndrome as well.12456

Who Is on the Research Team?

RB

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.
See 2 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Group: Exparel, no opioidsExperimental Treatment1 Intervention
Group II: Control Group; Bupivacaine + opioidsActive Control1 Intervention

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

🇺🇸
Approved in United States as Exparel for:

Find a Clinic Near You

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

Citations

Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. [2022]
Liposomal Bupivacaine Versus Standard Periarticular Injection in Total Knee Arthroplasty With Regional Anesthesia: A Prospective Randomized Controlled Trial. [2019]
Perineural dexamethasone attenuates liposomal bupivacaine-induced delayed neural inflammation in mice in vivo. [2020]
Extended Release Liposomal Bupivacaine Injection (Exparel) for Early Postoperative Pain Control Following Pharyngoplasty. [2018]
Neurological and histological outcomes after subarachnoid injection of a liposomal bupivacaine suspension in pigs: a pilot study. [2019]
Multivesicular liposomal bupivacaine at the sciatic nerve. [2022]
Local infiltration of liposome bupivacaine in orthopedic trauma patients: case-based reviews. [2022]
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