Primary Osteoarthritis, Unspecified Shoulder
Conditions
Brief summary
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
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.
Interventions
DRUGRopivacaine
The drug used for the interscalene blocks
Sponsors
TriHealth Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score Measure | participants will be followed for the duration of the hospital stay, an expected average of 3 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morphine Sulfate Equivalence consumption | participants morphine sulfate consumption will be gathered for the duration of the hospital stay, an expected average of 3 days | Total Morphine Sulfate equivalence consumption for each post-operative day while in the hospital will be collected through Electronic medical record. |
| Pain control Satisfaction Score | 10 day post operative | 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 |
Countries
United States
Outcome results
None listed