← Back to Search

Interscalene Catheter vs. Single Shot Block for Postoperative Shoulder Pain

N/A

Recruiting

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

Must not have

Neuropathy of the planned extremity to block

Unable to communicate in English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months post-operatively

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

Select...

My health is good to moderately impaired.

Select...

My upcoming surgery is not an emergency.

Select...

I am between 18 and 89 years old.

Exclusion Criteria

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

Select...

I have nerve pain or damage in the limb where the procedure is planned.

Select...

I cannot communicate in English.

Select...

I do not have severe lung problems or allergies to specific nerve block medications.

Select...

I have been diagnosed with kidney failure.

Select...

I have a fracture.

Select...

I am on blood thinners and cannot have a regional block.

Select...

I have been using opioids regularly before surgery, more than 20 MME.

Select...

I am scheduled for or have had revision surgery.

Select...

My liver is failing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months post-operatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months post-operatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post-operatively for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Pain Score Assessed by functional pain score at POD 1

Secondary study objectives

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 more

Awards & Highlights

No Placebo-Only Group

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

Trial 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

0 / 12Eligibility criteria met