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Enhanced Nerve Block for Postoperative Pain

Phase 4

Recruiting

Led By Audrice Francois, MD

Research Sponsored by Loyola University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients ≥ 18 years old

Patients undergoing shoulder arthroscopy

Must not have

Patient refusal

Total shoulder arthroplasty

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Drug Has Already Been Approved

Summary

This trial aims to find if adding drugs to a nerve block can reduce post-op morphine use in shoulder surgery.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects may include nausea from buprenorphine; low blood pressure or dry mouth from clonidine; and increased blood sugar levels or insomnia from dexamethasone.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am scheduled for or have had a shoulder arthroscopy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I use opioids daily for chronic pain.

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

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I weigh less than 60 kg.

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I am not experiencing confusion about who I am, where I am, or the current time.

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I have pain in a different area than where I had surgery.

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I have an active infection where the injections are supposed to be given.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Morphine requirement post surgery

Secondary study objectives

Pain reported via a numeric rating scale (NRS)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Interscalene block with the addition of buprenorphine, clonidine, dexamethasoneExperimental Treatment1 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 aloneActive Control1 Intervention

0 / 10Eligibility criteria met