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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
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I am willing to join the study and can sign the consent form.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Morphine requirement post surgery
Secondary outcome measures
Pain reported via a numeric rating scale (NRS)

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
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.

Find a Location

Who is running the clinical trial?

Loyola UniversityLead Sponsor
156 Previous Clinical Trials
30,802 Total Patients Enrolled
Audrice Francois, MDPrincipal InvestigatorLoyola University Chicago

Media Library

Interscalene block with buprenorphine alone (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05824832 — Phase 4
Postoperative Pain Research Study Groups: Interscalene block with buprenorphine alone, Interscalene block with the addition of buprenorphine, clonidine, dexamethasone
Postoperative Pain Clinical Trial 2023: Interscalene block with buprenorphine alone Highlights & Side Effects. Trial Name: NCT05824832 — Phase 4
Interscalene block with buprenorphine alone (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05824832 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the combination of Interscalene block, buprenorphine, clonidine and dexamethasone recognized by the US Food & Drug Administration?

"There is substantial evidence backing the safety of this interscalene block treatment, which includes buprenorphine, clonidine and dexamethasone; thus it has been rated a 3 on our 1-3 scale."

Answered by AI

How many participants are currently taking part in this clinical trial?

"Affirmative, the posted information on clinicaltrials.gov indicates that this medical study is actively enrolling participants. This trial was initially announced on February 28th 2023 and has been amended most recently on April 10th 2023; a total of 120 patients are needed from 1 centre."

Answered by AI

Is there a possibility for enrolment in this research endeavor?

"Affirmative. The information on clinicaltrials.gov suggests that this trial is currently recruiting members, having first been posted on February 28th 2023 and recently edited on April 10th 2023. 120 patients are needed from a single medical centre."

Answered by AI
~64 spots leftby Jun 2025