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

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 2 3 5 6}

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. ^{1 2 4 5 7}

Research Team

Ronald Buczek, DO

Principal Investigator

Kettering Health Network

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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™ (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]

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]

References

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

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

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

Liposomal Bupivacaine Versus Standard Periarticular Injection in Total Knee Arthroplasty With Regional Anesthesia: A Prospective Randomized Controlled Trial. [2019]

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

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

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

Extended Release Liposomal Bupivacaine Injection (Exparel) for Early Postoperative Pain Control Following Pharyngoplasty. [2018]

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

Neurological and histological outcomes after subarachnoid injection of a liposomal bupivacaine suspension in pigs: a pilot study. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Multivesicular liposomal bupivacaine at the sciatic nerve. [2022]

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

Local infiltration of liposome bupivacaine in orthopedic trauma patients: case-based reviews. [2022]