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

126 Participants Needed

Trial Summary

What is the purpose of this trial?

Effective and safe control of pain after shoulder surgery is an important component of the post-surgical process. Patients who are comfortable in the early period after surgery are more satisfied with their experience and are better able to participate in rehabilitation exercises during their stay in the hospital. As surgeons and health care systems in the United States find themselves in the middle of an opioid epidemic, it is necessary to discover different options to provide patients pain relief that are both effective and safe in an effort to decrease the amount of pain medication used.

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 data supports the effectiveness of the drug Exparel vs Dexamethasone for reducing pain after rotator cuff surgery?

Research shows that dexamethasone, when used with bupivacaine, can significantly prolong pain relief after surgery and reduce the incidence of severe pain when nerve blocks wear off. This suggests that combining dexamethasone with bupivacaine, as in the Exparel treatment, may effectively manage postoperative pain. ^{1 2 3 4 5}

Is Dexamethasone safe for use in surgeries?

Dexamethasone, when used in surgeries, has been shown to reduce pain and the incidence of rebound pain without significant side effects. It has been used safely in various forms, such as intravenous and epidural, to enhance pain relief after surgery. ^{1 2 5 6 7}

How does the drug Dexamethasone differ from other treatments for rotator cuff surgery pain?

Dexamethasone is unique because it is a steroid that reduces inflammation and pain when given before surgery, and it can be administered in various ways, such as intravenously or epidurally, to enhance pain relief and reduce nausea after surgery. ^{1 3 5 6 8}

Eligibility Criteria

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

I am having a second surgery on my rotator cuff.

Non-English speakers

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

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

Dexamethasone for pain after outpatient shoulder surgery: a randomised, double-blind, placebo-controlled trial. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Intravenous Dexamethasone Dose on the Occurrence of Rebound Pain after Axillary Plexus Block in Ambulatory Surgery. [2023]

3. India pubmed.ncbi.nlm.nih.gov

Efficacy of epidural local anesthetic and dexamethasone in providing postoperative analgesia: A meta-analysis. [2022]

4. Japan pubmed.ncbi.nlm.nih.gov

Efficacy of epidural dexamethasone versus fentanyl on postoperative analgesia. [2022]

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

Epidural Dexamethasone for Postoperative Analgesia in Patients Undergoing Unilateral Inguinal Herniorrhaphy: A Comparative Study. [2018]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Analgesia after Epidural Dexamethasone is Further Enhanced by IV Dipyrone, but Not IV Parecoxibe Following Minor Orthopedic Surgery. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Particulate-steroid betamethasone added to ropivacaine in interscalene brachial plexus block for arthroscopic rotator cuff repair improves postoperative analgesia. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Dexamethasone effect on postoperative pain and tramadol requirement after thyroidectomy. [2013]