Exparel vs Dexamethasone for Rotator Cuff Surgery Pain

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Rothman Institute Orthopaedics

Must not be taking: Opioids

Disqualifiers: Pregnancy, Alcohol abuse, Narcotic abuse, 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 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Surgery day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores pain management strategies after shoulder surgery, specifically for rotator cuff repairs. It compares two pain relief methods: Exparel (a form of bupivacaine) alone and Exparel with Dexamethasone (a corticosteroid), to determine which reduces the need for pain medications more effectively. The goal is to enhance patient comfort post-surgery and decrease opioid reliance. Individuals undergoing their first rotator cuff surgery without a recent history of pain medication use may be suitable candidates for this trial. As a Phase 4 trial, the research focuses on an FDA-approved treatment, aiming to understand its benefits for a broader patient population.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have been using opioids in the 3 months before surgery, you may not be eligible to participate.

What is the safety track record for these treatments?

Research has shown that liposomal bupivacaine, also known as Exparel, is generally safe and effective for managing pain after shoulder surgery. It helps relieve pain and reduces the need for opioids during the first week post-surgery. Some patients report mild side effects, but these are usually not serious.

One study suggested that combining Exparel with dexamethasone may enhance pain relief. This combination aims to increase patient comfort and satisfaction without raising side effects.

Both treatments have been used in surgeries and have shown positive results. While no treatment is completely risk-free, evidence supports their safety when used as directed. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using Exparel with or without Dexamethasone for managing pain after rotator cuff surgery because it could offer longer-lasting pain relief compared to standard treatments. Unlike typical options that may require frequent dosing, Exparel uses liposomal bupivacaine, a formulation that releases the anesthetic slowly over time, potentially reducing the need for additional pain medications. Additionally, combining Exparel with Dexamethasone, a powerful anti-inflammatory, might enhance pain control and decrease inflammation even further, offering a more comprehensive approach to post-surgical pain management.

What evidence suggests that this trial's treatments could be effective for pain management after rotator cuff surgery?

Research has shown that Liposomal bupivacaine, also known as Exparel, provides pain relief comparable to other painkillers used in shoulder surgeries. It helps reduce the need for opioids, which are strong and potentially addictive. Some studies found that Exparel does not always offer more pain relief than other options, but it remains useful in managing pain. In this trial, one group of participants will receive Exparel alone, while another group will receive Exparel combined with dexamethasone, a drug that reduces inflammation. This combination aims to extend pain relief after surgery, keeping pain levels low and reducing the need for other pain medications. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with rotator cuff injuries who have undergone surgery. It's aimed at those seeking effective postoperative pain management without relying heavily on opioids, which can be addictive.

Inclusion Criteria

English speaking

Ability to complete surveys by phone or in person

Ability to provide informed consent

Exclusion Criteria

Non-English speakers

Existing contract with a pain specialist due to underlying preoperative pain syndrome

I am having a second surgery on my rotator cuff.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a shoulder block with Liposomal bupivacaine (Exparel) or Liposomal bupivacaine combined with Dexamethasone before rotator cuff repair surgery

Surgery day

1 visit (in-person)

Follow-up

Participants are monitored for postoperative pain levels and narcotic medication use

14 days

Daily self-reports

What Are the Treatments Tested in This Trial?

Interventions

• Bupivacaine Hcl 0.5% Inj
• Dexamethasone
• Liposomal bupivacaine

Trial Overview The study is testing the effectiveness of two different medications for managing pain after shoulder surgery: Dexamethasone and Liposomal bupivacaine (Exparel), compared to a standard treatment using Bupivacaine Hcl.

How Is the Trial Designed?

Group I: Group 1: Shoulder Block using Exparel Active Control 2 Interventions

Participants having rotator cuff repair surgery will receive Liposomal bupivacaine (Exparel) + bupivacaine given in their shoulder block before surgery.

Group II: Group 2: Shoulder Block using Exparel + Dexamethasone Active Control 3 Interventions

Participants having rotator cuff repair surgery will receive Liposomal bupivacaine (Exparel) + Dexamethasone + bupivacaine given in their shoulder block before surgery.

Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases
• Immune system disorders

Approved in United States as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders
• Neoplastic diseases
• Nervous system disorders

Approved in Canada as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases

Approved in Japan as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders

Who Is Running the Clinical Trial?

Rothman Institute Orthopaedics

Lead Sponsor

Trials

127

Recruited

22,600+

Published Research Related to This Trial

In a study of 44 patients undergoing unilateral inguinal herniorrhaphy, adding dexamethasone to epidural bupivacaine significantly accelerated the onset of sensory block and prolonged postoperative analgesia compared to bupivacaine alone.

The addition of dexamethasone also reduced the incidence of nausea, with only 22.7% of the control group experiencing nausea in the first hour post-procedure, while none in the dexamethasone group reported nausea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural Dexamethasone for Postoperative Analgesia in Patients Undergoing Unilateral Inguinal Herniorrhaphy: A Comparative Study. Razavizadeh, MR., Fazel, MR., Heydarian, N., et al.[2018]

Adding dexamethasone to epidural bupivacaine provides similar analgesic effects as adding fentanyl, significantly prolonging the time to first analgesic requirement and reducing postoperative pain medication consumption in patients after lower abdominal surgeries.

Dexamethasone also offers additional benefits, such as lower postoperative nausea compared to both bupivacaine alone and bupivacaine with fentanyl, highlighting its potential as an effective and safer option for postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of epidural dexamethasone versus fentanyl on postoperative analgesia. Khafagy, HF., Refaat, AI., El-Sabae, HH., et al.[2022]

A meta-analysis of five randomized controlled trials found that adding epidural dexamethasone to local anesthetics significantly reduces postoperative morphine consumption by an average of 7.89 mg, indicating its efficacy in pain management.

Patients receiving epidural dexamethasone also required fewer rescue analgesic boluses, with a risk ratio of 0.51, suggesting that it effectively decreases the need for additional pain relief after abdominal surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of epidural local anesthetic and dexamethasone in providing postoperative analgesia: A meta-analysis. Jebaraj, B., Khanna, P., Baidya, DK., et al.[2022]

Epidural administration of dexamethasone provided effective pain relief after minor orthopedic surgery, lasting about 7 hours, and reduced the need for additional painkillers compared to the control group.

Combining epidural dexamethasone with IV dipyrone significantly extended pain relief to 17 hours and decreased overall painkiller consumption, while adding IV parecoxibe did not enhance the analgesic effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesia after Epidural Dexamethasone is Further Enhanced by IV Dipyrone, but Not IV Parecoxibe Following Minor Orthopedic Surgery. Lauretti, GR., Righeti, CC., Kitayama, AT.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06139666

The Effect of Liposomal Bupivacaine Nerve Block (Exparel) ... The goal of this clinical trial is to investigate if there is a difference in pain after an arthroscopic rotator cuff surgery when a nerve block is performed ...

2. journaloei.scholasticahq.com journaloei.scholasticahq.com/article/117497-liposomal-bupivacaine-in-managing-postoperative-pain-following-shoulder-surgery

Liposomal Bupivacaine in Managing Postoperative Pain ... Liposomal bupivacaine is a long-acting local anesthetic that has shown promise as an opioid-sparing alternative for pain management following ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35430368/

Efficacy of liposomal bupivacaine for pain control in ... Our meta-analysis provides evidence indicating that LB is similar to non-LB agents in terms of overall pain relief and opioid requirements.

4. anesthesiologynews.com anesthesiologynews.com/Monographs-and-Whitepapers/Article/10-22/EXPAREL-reg-bupivacaine-liposome-injectable-suspension-in-Shoulder-Surgery-%E2%80%93-A-Surgeon-and-Anesthesia-Perspective/68407?ses=ogst

EXPAREL® (bupivacaine liposome injectable suspension) ... Fact or Myth: EXPAREL® (bupivacaine liposome injectable suspension) in Shoulder Surgery – A Surgeon and Anesthesia Perspective.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022480421001244

The Efficacy of Liposomal Bupivacaine for Opioid and Pain ... Liposomal bupivacaine did not demonstrate significant pain relief compared to placebo or active agents in 74.58% of RCTs.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02713230

Study Details | NCT02713230 | Efficacy, Safety, and ... This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study in 155 adult subjects undergoing primary unilateral total shoulder ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2018/022496s9lbl.pdf

EXPAREL (bupivacaine liposome injectable suspension) Limitations of Use. Safety and efficacy has not been established in other nerve blocks. AND ADMINISTRATION. • EXPAREL is intended for single-dose ...

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

Clinical Effectiveness of Perineural Liposomal Bupivacaine is ... Clinical Effectiveness of Perineural Liposomal Bupivacaine is Not Superior to Bupivacaine Hydrochloride for the Prevention of Postoperative Pain ...

9. aetna.com aetna.com/cpb/medical/data/900_999/0941.html

Bupivacaine Liposome (Exparel) - Medical Clinical Policy ... The authors concluded that liposome bupivacaine added to standard bupivacaine may lower pain and enhance patient's satisfaction in the first postoperative week ...