Enhanced Nerve Block for Postoperative Pain

Overseen By Susan Fargo

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Loyola University

Must not be taking: Opioids

Disqualifiers: Severe COPD, Dementia, Pregnancy, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 1

Duration: Surgery day

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether adding certain medications to a nerve block can reduce the need for morphine after shoulder surgeries. Researchers are comparing two treatments: one with buprenorphine alone and another with buprenorphine, clonidine, and dexamethasone (a corticosteroid). The goal is to determine which approach better manages post-surgery pain. This trial may suit individuals undergoing shoulder arthroscopy who do not regularly use opioids for chronic pain. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, allowing researchers to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are a chronic pain patient using opioids daily, you would not be eligible to participate.

What is the safety track record for these treatments?

Research shows that adding buprenorphine to nerve blocks can extend pain relief by about 8 hours and is usually well-tolerated, though some side effects have been reported. Studies also indicate that combining dexamethasone and clonidine with buprenorphine is safe, but complications can occur.

Including dexamethasone and clonidine in the combination remains safe, despite some potential issues. Overall, using these drugs in nerve blocks is common and has undergone safety research. While side effects are possible, studies suggest the treatment is generally safe. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments because they explore enhanced nerve block techniques for managing postoperative pain. The standard of care typically involves local anesthetics like bupivacaine alone. However, the study treatments add buprenorphine, clonidine, and dexamethasone to the mix. This combination aims to extend pain relief, reduce inflammation, and potentially lower the need for opioid pain medications. By combining these ingredients, the treatment could offer a more effective and longer-lasting pain management option post-surgery.

What evidence suggests that this trial's treatments could be effective for postoperative pain?

This trial will compare two different interscalene block treatments for postoperative pain. Research has shown that adding buprenorphine to local painkillers in nerve blocks can significantly extend pain relief. One study found that pain relief lasted an average of 17.4 hours with buprenorphine, compared to just 5.3 hours without it. In this trial, one group will receive an interscalene block with buprenorphine alone, while another group will receive an interscalene block with buprenorphine, clonidine, and dexamethasone. These additional drugs enhance pain control in nerve blocks, extending and improving pain relief after surgery. Although these combinations are generally safe, they can sometimes cause side effects, so discussing any concerns with a doctor is important. ^{2 5 6 7 8}

Who Is on the Research Team?

Audrice Francois, MD

Principal Investigator

Loyola University Chicago

Are You a Good Fit for This Trial?

This trial is for patients over 18 years old who are having shoulder arthroscopy and can give informed consent. It's not for pregnant individuals, those with infections at the injection site, chronic pain patients on daily opioids, people allergic to local anesthetics, or those with severe lung issues.

Inclusion Criteria

I am scheduled for or have had a shoulder arthroscopy.

I am willing to join the study and can sign the consent form.

Exclusion Criteria

I have chosen not to participate in certain treatments or procedures.

I am scheduled for or have had a total shoulder replacement.

I have severe COPD or another condition that makes general anesthesia risky.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive Interscalene brachial plexus blocks with or without the addition of buprenorphine, clonidine, and dexamethasone during upper extremity surgery

Surgery day

1 visit (in-person)

Follow-up

Participants are monitored for morphine requirements and pain levels post-surgery

48 hours

Monitoring at 0, 2, 24, and 48 hours post-surgery

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone
• Interscalene block with buprenorphine alone
• Interscalene block with the addition of buprenorphine, clonidine, dexamethasone
• Morphine requirements

Trial Overview The study is testing if adding buprenorphine, clonidine, and dexamethasone to an Interscalene brachial plexus block reduces morphine needs after upper extremity surgery compared to the block without these drugs.

How Is the Trial Designed?

Group I: Interscalene block with the addition of buprenorphine, clonidine, dexamethasone Experimental Treatment 1 Intervention

Interscalene brachial plexus blocks (ISB) is performed with a 22g x 50 mm PAJUNK SonoPlexⓇ II Facet S echogenic needle. Once adequate needle visualization is achieved within the correct anatomic position and plane, 30mL of 0.5% bupivacaine with 100 mcg clonidine, 0.3 mg buprenorphine, and 4 mg dexamethasone will be injected.

Group II: Interscalene block with buprenorphine alone Active Control 1 Intervention

Interscalene brachial plexus blocks (ISB) is performed with a 22g x 50 mm PAJUNK SonoPlexⓇ II Facet S echogenic needle. Once adequate needle visualization is achieved within the correct anatomic position and plane 30mL of 0.5% bupivacaine will be injected.

Interscalene block with buprenorphine alone is already approved in United States, European Union for the following indications:

Approved in United States as Interscalene brachial plexus block with buprenorphine for:

• Pain management for upper extremity surgery
• Shoulder arthroscopy

Approved in European Union as Interscalene brachial plexus block with buprenorphine for:

• Pain management for upper extremity surgery
• Shoulder arthroscopy

Who Is Running the Clinical Trial?

Loyola University

Lead Sponsor

Trials

161

Recruited

31,400+

Published Research Related to This Trial

In a study of 90 patients undergoing upper limb surgery, adding dexamethasone to levobupivacaine significantly prolonged the duration of both sensory and motor blocks compared to using levobupivacaine alone, with analgesia lasting an average of 1195 minutes versus 416 minutes in the control group.

Clonidine also extended analgesia duration but was less effective than dexamethasone, indicating that dexamethasone is a superior adjuvant for enhancing the effects of brachial plexus blocks without adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison Between Dexamethasone and Clonidine as Adjuvants to Levobupivacaine in the Supraclavicular Approach to the Brachial Plexus Block: A Double-Blind Study. Yadav, S., Yadav, K., Bogra, J., et al.[2023]

Both perineural and intravenous dexamethasone significantly prolonged the duration of pain relief after shoulder surgery compared to saline, with durations of 16.9 hours and 18.2 hours respectively, versus 13.8 hours for saline.

Intravenous dexamethasone resulted in lower opioid consumption in the first 24 hours post-surgery (17.1 mg) compared to saline (24.1 mg), while also reducing the need for anti-emetics, making it a safer option to avoid potential neural toxicity associated with perineural administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perineural versus intravenous dexamethasone as adjuncts to local anaesthetic brachial plexus block for shoulder surgery. Rosenfeld, DM., Ivancic, MG., Hattrup, SJ., et al.[2022]

In a study of 88 patients undergoing shoulder arthroscopy, adding dexamethasone to a bupivacaine and clonidine interscalene block significantly prolonged sensory (1457 vs. 833 minutes) and motor (1374 vs. 827 minutes) blockade compared to a control group.

Patients receiving dexamethasone reported lower pain scores and required less opioid medication in the first 24 hours post-surgery, indicating improved pain management without compromising patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone with bupivacaine increases duration of analgesia in ultrasound-guided interscalene brachial plexus blockade. Vieira, PA., Pulai, I., Tsao, GC., et al.[2022]

A combination of superficial cervical plexus block, suprascapular nerve block, and infraclavicular brachial plexus block allowed 95% of patients (19 out of 20) to undergo arthroscopic shoulder surgery with only light propofol sedation, avoiding the need for opioids or artificial airways.

All patients reported high satisfaction with this anesthetic approach, and surgeons rated the operating conditions as good, suggesting this method is a safe and effective alternative to traditional interscalene blocks and general anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel combination of peripheral nerve blocks for arthroscopic shoulder surgery. Musso, D., Flohr-Madsen, S., Meknas, K., et al.[2018]

The study found that using a medium dose of ropivacaine (0.2%) with perineural additives significantly reduced pain with movement at 24 hours post-surgery compared to the control group, indicating effective pain management.

Combining perineural additives with a low dose of ropivacaine (0.1%) minimized motor blockade while still providing superior hand strength in the Post-Anesthesia Care Unit, suggesting a balance between pain relief and motor function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine, Clonidine, Dexamethasone, and Ropivacaine for Interscalene Nerve Blockade: A Prospective, Randomized, Blinded, Ropivacaine Dose-Response Study. YaDeau, JT., Gordon, MA., Goytizolo, EA., et al.[2018]

In a study involving 160 patients undergoing elective shoulder surgery, the addition of adjuncts (clonidine, dexamethasone, or buprenorphine) to ropivacaine for interscalene brachial plexus blocks did not significantly improve the duration of analgesia compared to ropivacaine alone.

Despite the lack of significant differences in analgesia duration, the study noted a larger than expected variability in patient responses, suggesting that further research may be needed to fully understand the effects of these adjuncts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the effect of three different adjuvants on the analgesic duration of single injection interscalene brachial plexus block: a prospective, randomized, triple blinded clinical trial. Seering, MS., Bayman, EO., Wong, CA., et al.[2019]

In a study of 150 patients undergoing shoulder surgery, the addition of epineural buprenorphine significantly prolonged both the sensory block and postoperative analgesia compared to intramuscular buprenorphine and saline, with durations of 856.1 minutes and 1,049.7 minutes, respectively.

Epineural buprenorphine also reduced the need for postoperative rescue analgesics and was associated with very few complications, indicating its safety and effectiveness as a peripheral nerve block adjunct.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine added to levobupivacaine enhances postoperative analgesia of middle interscalene brachial plexus block. Behr, A., Freo, U., Ori, C., et al.[2022]

Adding dexamethasone to interscalene nerve blocks significantly prolongs pain relief from both ropivacaine and bupivacaine, with a median duration of analgesia reaching about 22 hours for both when combined with the steroid.

The prolongation of analgesia is more pronounced with ropivacaine compared to bupivacaine, although bupivacaine alone provides a longer duration of pain relief than ropivacaine without dexamethasone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of dexamethasone on the duration of interscalene nerve blocks with ropivacaine or bupivacaine. Cummings, KC., Napierkowski, DE., Parra-Sanchez, I., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22644357/

Buprenorphine added to levobupivacaine enhances ... Results: There were significant (P < 0.05) differences in the onset and the duration of the sensory block and in the duration of postoperative analgesia.

2. rapm.bmj.com rapm.bmj.com/content/26/4/352

Buprenorphine Added to the Local Anesthetic for Brachial ... Results The mean duration of postoperative pain relief following the injection of the local anesthetic alone was 5.3 (± 0.15) hours as compared with 17.4 (± ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06742554

Comparative Efficacy of Buprenorphine Transdermal Patch ... This study compares the efficacy, safety, and patient satisfaction of the Buprenorphine 10 mg transdermal patch versus Tramadol for postoperative analgesia in ...

4. rapm.bmj.com rapm.bmj.com/content/early/2025/07/23/rapm-2025-106583

Addition of liposomal bupivacaine in brachial plexus blocks Liposomal bupivacaine was associated with statistically significant reduction in resting pain scores at 24 hours after nerve block injection ...

5. academic.oup.com academic.oup.com/painmedicine/article-abstract/17/5/940/1752549

Buprenorphine, Clonidine, Dexamethasone, and Ropivacaine ... High Dose had less pain with movement the morning after surgery, vs Control; 2.9 ± 2.5 vs 4.9 ± 2.7; P = 0.027. Pain with movement in the Post- ...

6. withpower.com withpower.com/trial/phase-4-pain-postoperative-1-2023-acda6

Enhanced Nerve Block for Postoperative Pain The studies suggest that using dexamethasone, clonidine, and buprenorphine in nerve blocks is generally safe, but there can be complications, such as effects on ...

7. journals.lww.com journals.lww.com/painrpts/fulltext/2025/08000/interscalene_block_alone_vs_interscalene_block.27.aspx

Interscalene block alone vs interscalene block with erector ... Interscalene block alone was comparable to ESPB and ISB regarding postoperative pain. ... In shoulder surgeries, the interscalene brachial plexus block ...

8. asra.com asra.com/news-publications/asra-newsletter/newsletter-item/asra-news/2020/11/01/curb-your-enthusiasm-local-anesthetic-adjuvants-for-peripheral-nerve-blocks

Local Anesthetic Adjuvants for Peripheral Nerve Blocks Effect on analgesia: Addition of buprenorphine to a LA peripheral nerve block prolongs postoperative analgesia for 8 hours. Adverse effects: ...