Exparel for Post-Surgery Pain Management in Thyroid Conditions

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Missouri-Columbia

Disqualifiers: Opioid abuse, Anesthetic allergy, Opioid allergy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Exparel can reduce the need for opioid painkillers after thyroid and parathyroid surgery. Researchers aim to determine if a local injection of Exparel during surgery manages pain better than current methods. The study includes different groups: one receiving Exparel, another with bupivacaine (a pain relief medication), and a third using the standard practice with lidocaine. Individuals needing thyroid or parathyroid surgery who speak English as their primary language might be suitable for this trial. As an Early Phase 1 trial, this research focuses on understanding how Exparel works in people, offering participants a chance to contribute to groundbreaking pain management strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Exparel is generally well-tolerated by patients. In a study of 823 patients who received Exparel, fewer than 2% experienced side effects such as chills, slow heart rate, and anxiety. Most side effects were mild and temporary.

Research indicates that Bupivacaine Hydrochloride with Epinephrine effectively manages post-surgical pain. Common side effects include nausea and temporary numbness, while serious side effects are rare, occurring in about 8% of cases.

Both treatments aim to reduce pain and limit the need for opioids after surgery. While side effects can occur, they are usually manageable and not severe. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Exparel for post-surgery pain management in thyroid conditions because it offers a novel approach compared to standard care options like lidocaine with epinephrine. Exparel uses bupivacaine hydrochloride with epinephrine, but what's unique is its extended-release formulation, which can provide longer-lasting pain relief after surgery. Unlike typical anesthetics that may require multiple doses, Exparel can be administered just once, potentially reducing the need for additional pain medications and improving patient comfort. This innovation could lead to more effective and convenient pain management for patients undergoing thyroid and parathyroid surgeries.

What evidence suggests that this trial's treatments could be effective for post-surgery pain management in thyroid conditions?

In this trial, participants will receive different treatments to manage post-surgery pain. Studies have shown that Exparel, a special form of the pain reliever bupivacaine, can effectively manage pain after surgery. One study found that 95% of patients were satisfied with their pain relief using Exparel three days post-surgery. However, other research suggests that Exparel does not always provide better pain relief than other treatments. Another treatment arm in this trial involves using bupivacaine with epinephrine, which has been effective in reducing pain after thyroid surgeries and can lower the need for additional pain medications. Both treatments show promise, but their effectiveness can vary depending on the situation and individual patient response. ^{1 2 3 6 7}

Who Is on the Research Team?

Tabitha Galloway, MD

Principal Investigator

University of Missouri Department of Otolaryngology-Head and Neck Surgery

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 who need thyroid or parathyroid surgery. It's not open to those under 18, with a history of opioid abuse, or allergies to local anesthetics or opioids.

Inclusion Criteria

I need surgery for my parathyroid or thyroid as recommended by my doctor.

I am over 18 years old.

English as primary language

Exclusion Criteria

I am under 18 years old.

You have a history of misusing opioid medications.

You have a real allergy to any local numbing medicine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo thyroid or parathyroid surgery with different local anesthetic protocols

1 day

1 visit (in-person)

Postoperative Monitoring

Participants' pain scores and opioid usage are evaluated using a pain journal and electronic medical records

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bupivacaine Hydrochloride-EPINEPHrine
• Lidocaine Epinephrine
• Lidocaine Epinephrine, Bupivacaine Hydrochloride-EPINEPHrine

Trial Overview The study tests if Exparel, when injected during surgery, reduces the need for opioid painkillers after thyroid and parathyroid surgeries. It aims to improve postoperative pain management.

How Is the Trial Designed?

Group I: Exparel Injection Experimental Treatment 1 Intervention

Thyroid and parathyroid surgery with local injection of lidocaine and epinephrine preincison and Exparel postincision

Group II: Bupivicaine HCL Experimental Treatment 1 Intervention

Thyroid or parathyroid surgery with local injection of bupivicaine HCL and Epinephrine preincision.

Group III: Current Practice Active Control 1 Intervention

Thyroid or parathyroid surgery with local injection of lidocaine and epinephrine preincision, as is current practice.

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

Published Research Related to This Trial

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 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]

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 of 111 patients undergoing total thyroidectomy, bilateral superficial cervical plexus block with 0.75% ropivacaine, whether administered before or after surgery, did not improve postoperative pain management compared to no block.

There were no significant differences in morphine requirements, pain intensity scores, or overall opioid consumption among the groups, indicating that this method of analgesia may not be effective for enhancing pain relief in this surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The bilateral superficial cervical plexus block with 0.75% ropivacaine administered before or after surgery does not prevent postoperative pain after total thyroidectomy. Herbland, A., Cantini, O., Reynier, P., et al.[2022]

EXPAREL® (bupivacaine liposome injectable suspension) is an FDA-approved extended-release anesthetic that significantly reduces postoperative pain and opioid consumption in patients undergoing total knee and hip replacement surgeries, as shown in multiple phase 2 and phase 3 studies.

Using EXPAREL® as part of a multimodal pain management approach leads to better outcomes, including lower pain scores, reduced need for rescue opioids, and improved patient satisfaction during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances in incorporation of local analgesics in postsurgical pain pathways. Lombardi, AV.[2014]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4970774/

Local bupivacaine for postoperative pain management in ... Intraoperative local bupivacaine application is effective in decreasing postoperative pain in patients with thyroidectomy.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03682224

Exparel and Marcaine for Pain Management in ... The purpose of this study is to assess pain management after elective thoracoscopic lobectomy. The study will compare two local anesthetics that are given ...

3. withpower.com withpower.com/trial/exparel-for-post-surgery-pain-management-in-thyroid-conditions-74bdb

Exparel for Post-Surgery Pain Management in Thyroid ... Research shows that using bupivacaine with epinephrine after thyroid surgery can help reduce pain and the need for additional pain medication. This suggests ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12277084/

Clinical Effectiveness of Perineural Liposomal Bupivacaine is ... The objective of the present meta-analysis was to investigate the efficacy of liposomal bupivacaine in acute pain management after orthopedic ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04362566?tab=table

NCT04362566 | Bupivacaine for Post-operative Pain in Mohs A newer formulation of liposomal bupivacaine has been shown to be even longer lasting and safer, with pain control up to 72 hours and no reported cardiac ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2352587825001160

Research progress of liposomal bupivacaine and its value ... These findings suggest that LB may be a safe and promising agent for prolonging postoperative analgesia and minimizing donor site pain. Some studies have ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6318344/

Safety and Efficacy of Bupivacaine HCl Collagen-Matrix ... Surgical site infiltration with bupivacaine results in short-lived analgesia. The MATRIX-1 and MATRIX-2 studies examined the efficacy and ...