Effective Pain Management of Interscalene Blocks During Shoulder Surgery

Study Overview
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Brief Summary
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Shoulder replacement surgery is recognized as having the potential to cause a considerable amount of postoperative pain. Adequate management of pain after surgery is necessary not only to improve the patient's wellbeing but also to facilitate recovery. Several regional anesthesia techniques are available to combat postoperative pain in the shoulder replacement surgery patient, however, which method provides superior pain relief remains unknown. The purpose of this study is to examine the effectiveness of a continuous interscalene block versus a single shot interscalene block for postoperative pain relief in the shoulder replacement patient. Patients undergoing shoulder replacement surgery will experience more effective pain relief with a continuous interscalene block versus and single shot interscalene block.

Detailed Description
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This is a prospective randomized controlled trial. 76 patients receiving either primary total shoulder replacement, hemiarthroplasty, or reverse total shoulder replacement will be randomized to a regional anesthesia technique as part of their surgical procedure. 38 patients will receive a single shot interscalene block containing ropivicaine and 38 patients will receive a continuous interscalene block containing ropivicaine.

Official Title
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Effective Pain Management of Continuous Versus Single Shot Injection Interscalene Block During Shoulder Replacement Surgery

Conditions
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Primary Osteoarthritis, Unspecified Shoulder

Intervention / Treatment
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* Drug: Ropivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Surgical candidate for primary total shoulder replacement, hemiarthroplasty, or reverse total shoulder replacement patient must be 18 years or older and willing to sign and date an Institutional Review Board informed consent form, and must be able to understand and agree to follow study protocol. Exclusion Criteria: severe bronchopulmonary disease, oxygen dependent, existing nerve injury, BMI > 40, coagulation disorders, allergy to ropivicaine, history of drug or alcohol abuse, American Academy of Anaesthesiologists physical status classification > lll, pregnant women.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ropivacaine Single Shot Block<br>Single Shot Interscalene block patients will receive a single shot of 30ml of 0.5% Ropivacaine prior to surgery | Drug: Ropivacaine<br>* The drug used for the interscalene blocks<br>* Other names: Naropin;|
| Active Comparator: Ropivacaine Continuous block<br>Continuous Interscalene block patients will receive a shot of up to 30ml of 0.5% Ropivacaine and then a catheter is placed. The catheter is secured with Dermabond and Tegaderm. Once surgery is complete, the catheter is connected to a pain ball system which holds 400ml of 0.2% Ropivacaine local anesthetic. The rate is locked in at 8ml/hr. Catheter is pulled once the pain ball is empty. | Drug: Ropivacaine<br>* The drug used for the interscalene blocks<br>* Other names: Naropin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score Measure | Patients will be assessed for pain levels by visual analog scale while in the hospital per nursing protocol. Electronic Medical Record will be used to acquire pain scores. | participants will be followed for the duration of the hospital stay, an expected average of 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine Sulfate Equivalence consumption | Total Morphine Sulfate equivalence consumption for each post-operative day while in the hospital will be collected through Electronic medical record. | participants morphine sulfate consumption will be gathered for the duration of the hospital stay, an expected average of 3 days | 
| Pain control Satisfaction Score | Patient's post operative pain control satisfaction score will be obtained at the first post operative follow up visit with the physician which is expected to occur on avearage 10 days after surgery | 10 day post operative |