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Enhanced Nerve Block for Postoperative Pain
Study Summary
This trial aims to find if adding drugs to a nerve block can reduce post-op morphine use in shoulder surgery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am 18 years old or older.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.I have severe COPD or another condition that makes general anesthesia risky.I weigh less than 60 kg.I am not experiencing confusion about who I am, where I am, or the current time.I have pain in a different area than where I had surgery.I am scheduled for or have had a shoulder arthroscopy.You are allergic to local anesthetics.I have an active infection where the injections are supposed to be given.I am willing to join the study and can sign the consent form.
- Group 1: Interscalene block with buprenorphine alone
- Group 2: Interscalene block with the addition of buprenorphine, clonidine, dexamethasone
- 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.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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