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Interscalene Catheter vs. Single Shot Block for Postoperative Shoulder Pain
N/A
Waitlist Available
Led By Melinda Seering, MD
Research Sponsored by Melinda Seering
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ASA class I, II, or III
Non-Emergency Surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post-operatively
Awards & highlights
Study Summary
This trial will compare post-op pain relief after shoulder surgery, comparing a single shot block with a catheter. #painrelief #shouldersurgery
Who is the study for?
This trial is for adults aged 18-89 undergoing reverse shoulder replacement surgery who can give informed consent and are not on anticoagulants, without significant lung disease, kidney or liver failure, neuropathy in the affected limb, chronic opioid use over 20 MME, fractures, revision surgeries or an inability to cooperate during block placement.Check my eligibility
What is being tested?
The study compares two types of pain management after shoulder surgery: one group receives a continuous interscalene catheter delivering medication while the other gets a single injection called Exparel. The goal is to see which method better controls post-operative pain.See study design
What are the potential side effects?
Possible side effects may include discomfort at the injection site, potential nerve injury from needle placement for both methods. There's also a risk of medication-related side effects like nausea or allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My health is good to moderately impaired.
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My upcoming surgery is not an emergency.
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I am between 18 and 89 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post-operatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post-operatively
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain Score Assessed by functional pain score at POD 1
Secondary outcome measures
Functional Status of the patient (2 weeks) via ASES questionnaire
Functional Status of the patient (3 months) via ASES questionnaire
Functional Status of the patient (6 months) via ASES questionnaire
+11 moreTrial Design
2Treatment groups
Active Control
Group I: Interscalene CatheterActive Control1 Intervention
One of the current standard of care for shoulder replacement surgery at our institution is to receive an interscalene catheter for pre-operatively
Group II: Exparel Single Shot Interscalene BlockActive Control1 Intervention
One of the current standard of care for shoulder replacement surgery at our institution is to receive a pre-operative single shot interscalene block with Exparel
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Who is running the clinical trial?
Melinda SeeringLead Sponsor
2 Previous Clinical Trials
195 Total Patients Enrolled
1 Trials studying Postoperative Pain
35 Patients Enrolled for Postoperative Pain
Melinda Seering, MDPrincipal InvestigatorUniversity of Iowa
2 Previous Clinical Trials
283 Total Patients Enrolled
1 Trials studying Postoperative Pain
35 Patients Enrolled for Postoperative Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have nerve pain or damage in the limb where the procedure is planned.I cannot communicate in English.I do not have severe lung problems or allergies to specific nerve block medications.My health is good to moderately impaired.My upcoming surgery is not an emergency.You are not able to follow instructions during the block placement.I have been diagnosed with kidney failure.I have a fracture.I am between 18 and 89 years old.I am on blood thinners and cannot have a regional block.I have been using opioids regularly before surgery, more than 20 MME.I am scheduled for or have had revision surgery.I am having reverse shoulder replacement surgery.My liver is failing.
Research Study Groups:
This trial has the following groups:- Group 1: Interscalene Catheter
- Group 2: Exparel Single Shot Interscalene Block
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this medical research open to geriatric patients?
"This medical trial is open to individuals that have exceeded the age of majority and are under 90 years old."
Answered by AI
Who is qualified to join this clinical trial?
"This medical study is searching for 56 individuals with postoperative pain who are between the ages of 18 and 90. In order to be eligible, applicants must meet these criteria."
Answered by AI
Are there any remaining vacancies in this clinical trial?
"This research endeavour, which was first posted on the 1st of May 2023 and last amended on 19th May 2023 is not currently open for patient recruitment. Although this trial has reached its quota, there are 664 other trials actively looking for volunteers as we speak."
Answered by AI
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