Primary Osteoarthritis, Unspecified Shoulder Clinical Trial
Official title:
Effective Pain Management of Continuous Versus Single Shot Injection Interscalene Block During Shoulder Replacement Surgery
| NCT number | NCT02267044 |
| Other study ID # | 14061 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | August 2014 |
| Est. completion date | April 2017 |
| Verified date | October 2018 |
| Source | TriHealth Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 76 |
| Est. completion date | April 2017 |
| Est. primary completion date | October 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Good Samaritan Hospital | Cincinnati | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| TriHealth Inc. |
United States,
Borgeat A, Tewes E, Biasca N, Gerber C. Patient-controlled interscalene analgesia with ropivacaine after major shoulder surgery: PCIA vs PCA. Br J Anaesth. 1998 Oct;81(4):603-5. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 |