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

Trial Summary

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 data supports the effectiveness of the drug combination used in the Enhanced Nerve Block for Postoperative Pain trial?

Research shows that adding dexamethasone to nerve blocks can extend pain relief after surgery, and combining buprenorphine with local anesthetics like levobupivacaine enhances postoperative pain control. Additionally, using dexamethasone with ropivacaine in nerve blocks reduces the need for opioids like morphine after surgery. ^{1 2 3 4 5}

Is the enhanced nerve block for postoperative pain generally safe for humans?

The studies suggest that using dexamethasone, clonidine, and buprenorphine in nerve blocks is generally safe, but there can be complications, such as effects on the phrenic nerve (a nerve important for breathing). Always discuss potential risks with your doctor. ^{1 2 3 6 7}

How is the enhanced nerve block treatment for postoperative pain unique?

This treatment is unique because it combines buprenorphine, clonidine, and dexamethasone with an interscalene block to potentially extend pain relief after surgery. The combination of these drugs aims to provide longer-lasting pain relief compared to using each drug alone. ^{1 2 3 5 8}

What is the purpose of this trial?

The goal of this clinical trial is to learn if there is a difference in morphine requirements in patients after upper extremity surgeries including shoulder arthroscopy. The main question it aims to answer is whether there is a difference between Interscalene brachial plexus blocks with the addition of buprenorphine, dexamethasone, and clonidine and the same block without the adjuvant.

Research Team

Audrice Francois, MD

Principal Investigator

Loyola University Chicago

Eligibility Criteria

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 use opioids daily for chronic pain.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

References

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

Dexamethasone with bupivacaine increases duration of analgesia in ultrasound-guided interscalene brachial plexus blockade. [2022]

2. England 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. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Buprenorphine, Clonidine, Dexamethasone, and Ropivacaine for Interscalene Nerve Blockade: A Prospective, Randomized, Blinded, Ropivacaine Dose-Response Study. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Perineural versus intravenous dexamethasone as adjuncts to local anaesthetic brachial plexus block for shoulder surgery. [2022]

5. Japan pubmed.ncbi.nlm.nih.gov

Buprenorphine added to levobupivacaine enhances postoperative analgesia of middle interscalene brachial plexus block. [2022]

6. United States 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. [2023]

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

A novel combination of peripheral nerve blocks for arthroscopic shoulder surgery. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Effect of dexamethasone on the duration of interscalene nerve blocks with ropivacaine or bupivacaine. [2022]