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

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the drug Bupivacaine Hydrochloride-EPINEPHrine for post-surgery pain management in thyroid conditions?

Research shows that using bupivacaine with epinephrine after thyroid surgery can help reduce pain and the need for additional pain medication. This suggests that the drug may be effective for managing post-surgery pain in thyroid conditions. ^{1 2 3 4 5}

Is Exparel safe for managing post-surgery pain?

Liposome bupivacaine (Exparel) has been studied for safety in clinical trials, showing it is generally safe for use in managing post-surgical pain when administered as a single dose at the surgical site. ^{1 2 4 5 6}

How does the drug Exparel differ from other treatments for post-surgery pain management in thyroid conditions?

Exparel is unique because it is an extended-release local anesthetic that provides long-lasting pain relief with a single injection at the surgical site, reducing the need for opioids and potentially leading to fewer side effects. This approach is different from traditional pain management methods that often require multiple doses and higher opioid use. ^{6 7 8 9 10}

What is the purpose of this trial?

The question proposed by this study, is one of patient outcomes. Does intraoperative injection of Exparel decrease postoperative use of opioid pain medications in patients undergoing thyroid and parathyroid surgery? The trial seeks to assess the effect that Exparel has on postoperative pain control.

Research Team

Tabitha Galloway, MD

Principal Investigator

University of Missouri Department of Otolaryngology-Head and Neck Surgery

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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

The bilateral superficial cervical plexus block with 0.75% ropivacaine administered before or after surgery does not prevent postoperative pain after total thyroidectomy. [2022]

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

Randomized controlled trial on the efficacy of bilateral superficial cervical plexus block in thyroidectomy. [2022]

3. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Bupivacaine application reduces post thyroidectomy pain: Cerrahpasa experience. [2020]

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

Prospective, randomized controlled trial on use of ropivacaine after robotic thyroid surgery: Effects on postoperative pain. [2018]

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

Evaluation of etidocaine hydrochloride for local anesthesia and postoperative pain control in oral surgery. [2019]

6. England pubmed.ncbi.nlm.nih.gov

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

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

Safety and Efficacy of Long-Acting Liposomal Bupivacaine Plus Bupivacaine Hydrochloride for Dorsal Penile Block During Ambulatory Pediatric Urologic Surgery. [2023]

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

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

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

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

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

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