Local Anesthetic + Education for Carpal Tunnel Syndrome
Recruiting in Palo Alto (17 mi)
Overseen byRonald Buczek, DO
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Kettering Health Network
Must not be taking: Opioids, Tricyclic antidepressants
Disqualifiers: Bupivacaine allergy, Percocet allergy, others
No Placebo Group
Prior Safety Data
Approved in 1 Jurisdiction
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.
12345Is 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.
12356What 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.
12457Eligibility 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.
+2 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Group: Exparel, no opioidsExperimental Treatment1 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 + opioidsActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Orthopedic Associates of Southwest OhioDayton, OH
Loading ...
Who Is Running the Clinical Trial?
Kettering Health NetworkLead Sponsor
American Society for Surgery of the HandCollaborator
References
Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. [2022]Liposome bupivacaine (Exparel) is a multivesicular liposomal formulation of bupivacaine currently approved in the United States for single-dose administration into the surgical site to provide postsurgical analgesia. This retrospective analysis examined safety data from clinical trials involving the off-label use of this formulation in peripheral nerve blocks.
Liposomal Bupivacaine Versus Standard Periarticular Injection in Total Knee Arthroplasty With Regional Anesthesia: A Prospective Randomized Controlled Trial. [2019]Liposomal bupivacaine (Exparel) is a long-acting local anesthetic preparation with demonstrated efficacy over placebo in reducing postoperative pain and opioid requirement. Limited comparative efficacy and cost-effectiveness data exist for its use in total knee arthroplasty (TKA) when used in a multimodal, opioid-sparing analgesic and anesthetic approach. We hypothesized that liposomal bupivacaine offers no clinical advantage over our standard of care but carries significant economic impact.
Perineural dexamethasone attenuates liposomal bupivacaine-induced delayed neural inflammation in mice in vivo. [2020]Liposomal bupivacaine (Exparel®) is a sustained-release formulation of bupivacaine for use in surgical infiltration anaesthesia. We analysed the histological nerve toxicity and clinical effectiveness of perineural Exparel® alone or with added dexamethasone in a mouse model.
Extended Release Liposomal Bupivacaine Injection (Exparel) for Early Postoperative Pain Control Following Pharyngoplasty. [2018]Liposomal bupivacaine (LB, Exparel) is a long-acting local anesthetic reported to decrease postoperative. The authors demonstrate the first safe use of LB in pediatric patients with improved pain control following pharyngoplasty.
Neurological and histological outcomes after subarachnoid injection of a liposomal bupivacaine suspension in pigs: a pilot study. [2019]An injectable liposomal bupivacaine suspension (EXPAREL™) is approved by the US Food and Drug Administration for analgesia by tissue infiltration and interscalene brachial plexus, but not for use in the neuraxial space. This pilot study describes neurological and histological outcomes of escalating doses of this extended-release formulation of bupivacaine after subarachnoid administration.
Multivesicular liposomal bupivacaine at the sciatic nerve. [2022]Clinical translation of sustained release formulations for local anesthetics has been limited by adverse tissue reaction. Exparel™ (DepoFoam bupivacaine) is a new liposomal local anesthetic formulation whose biocompatibility near nerve tissue is not well characterized. Exparel™ injection caused sciatic nerve blockade in rats lasting 240 min compared to 120 min for 0.5% (w/v) bupivacaine HCl and 210 min for 1.31% (w/v) bupivacaine HCl (same bupivacaine content as Exparel™). On histologic sections four days after injection, median inflammation scores in the Exparel™ group (2.5 of 4) were slightly higher than in groups treated with bupivacaine solutions (score 2). Myotoxicity scores in the Exparel™ group (2.5 of 6) were similar to in the 0.5% (w/v) bupivacaine HCl group (3), but significantly less than in the 1.31% (w/v) bupivacaine HCl group (5). After two weeks, inflammation from Exparel™ (score 2 of 6) was greater than from 0.5% (w/v) bupivacaine HCl (1) and similar to that from 1.31% (w/v) bupivacaine HCl (1). Myotoxicity in all three groups was not statistically significantly different. No neurotoxicity was detected in any group. Tissue reaction to Exparel™ was similar to that of 0.5% (w/v) bupivacaine HCl. Surveillance for local tissue injury will be important during future clinical evaluation.
Local infiltration of liposome bupivacaine in orthopedic trauma patients: case-based reviews. [2022]Orthopedic trauma surgery is often associated with considerable postoperative pain, which can result in a cascade of direct and indirect clinical consequences. Patients undergoing orthopedic trauma surgery are at risk for the development of chronic postsurgical pain, which may persist for 2 years or longer. Effective approaches to reducing postoperative pain in orthopedic trauma surgery patients include the use of minimally invasive procedures and multimodal analgesia. Infiltration of the surgical site with EXPAREL® (bupivacaine liposome injectable suspension), an extended-release local anesthetic, represents an advance in the multimodal management of postoperative pain. As part of a multimodal regimen, EXPAREL® has been shown to provide effective, safe, and efficient analgesia across a range of surgical procedures. Two cases that illustrate the use of EXPAREL® in orthopedic trauma are described. The first case involves repair of a subtrochanteric nonunion in a 63-year-old woman with a history of bisphosphonate use and prior treatment with a cephalomedullary nail. The second case involves a young woman undergoing outpatient surgery for repair of a fractured clavicle. Both patients experienced good control of postsurgical pain, supporting the clinical utility of EXPAREL® in orthopedic trauma surgery.