Osteoarthritis Clinical Trial
Official title:
Is There a Difference Between Posterior Approach Ultrasound-guided Continuous Interscalene Block (Upper Trunk Block) and Stimulator Guided Continuous Cervical Paravertebral Block (C6 Root Block)?
Verified date | July 2019 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study will answer the question whether there is a difference in the effects and complication rates of ultrasound guided continuous interscalene block (CISB) and nerve stimulation-guided continuous cervical paravertebral block (CCPVB). The aim of this study is to evaluate the differences in efficacy and side effects - if any.
Status | Completed |
Enrollment | 53 |
Est. completion date | September 26, 2018 |
Est. primary completion date | June 6, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - The general inclusion will be those adult patients who: - are between the ages of 18 and 80 years - have an ASA Health Classification of I, II, or III - are scheduled for shoulder arthroplasty or rotator cuff repair surgery - Patients with a BMI of =to/< 40 Exclusion The Exclusion criteria will include: - Patient refusal to participate in the study or sign informed consent - Patients with contraindications to any of the two blocks or allergy to any of the drugs used - Patients with shoulder surgery that developed into any other surgery other than total shoulder arthroplasty or rotator cuff repair - Patients with a BMI >40 |
Country | Name | City | State |
---|---|---|---|
United States | Florida Surgical Center | Gainesville | Florida |
United States | UF Health | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida | I. Heermann Anesthesia Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes between the two groups assessed by sensory testing | Sensory abnormalities will be assessed by sensation of cold and dermatomes sensation. | Change from baseline up to 7 days (end of catheter placement) | |
Secondary | Changes between the two groups assessed by motor strength | Motor strength will be assessed on a scale of 0 to 5 Medical Research Council (MRC) scale | Change from baseline up to 7 days (end of catheter placement) | |
Secondary | Changes between the two groups assessed by shoulder pain | Shoulder pain will be assessed by the Defense and Veterans Pain Rating Scale (DVPRS) where pain will be rated as no pain, mild, moderate, or severe pain, and on a scale of 0 to 10 where 0 represents no pain, 1 to 3 represents mild pain, 4 to 6 represents moderate pain, 7 to 9 represents severe pain, and 10 represents the worst pain imaginable where nothing else but the pain matters | Change from baseline up to 7 days (end of catheter placement) | |
Secondary | Changes between the two groups assessed by Phrenic nerve function | Phrenic nerve function will be evaluated by measuring the movements of the diaphragm by ultrasonography or the inability to visualize using ultrasound (US) | Change from baseline up to 7 days (end of catheter placement) | |
Secondary | Changes between the two groups assessed by recurrent laryngeal nerve (RLN) function | RLN function will be assessed by hoarseness or swallowing difficulty | Change from baseline up to 7 days (end of catheter placement) | |
Secondary | Changes between the two groups assessed by development of ipsilateral Horner's syndrome | Development of ipsilateral Horner's syndrome | Change from baseline up to 7 days (end of catheter placement) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04657926 -
A Trial of APPA in the Treatment of Knee Osteoarthritis
|
Phase 2 | |
Completed |
NCT02536833 -
A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects
|
Phase 2 | |
Completed |
NCT03014037 -
Comparing Mesenchymal Stem Cell Counts in Unilateral vs. Bilateral Posterior Superior Iliac Spine Bone Marrow Aspiration
|
N/A | |
Recruiting |
NCT05937542 -
A Qualitative Investigation of CLEAT Participants
|
||
Completed |
NCT03644615 -
A Mindfulness Program (MBSR) in the Management of Symptomatic Hip and Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT06061367 -
Muscles Strength and Gait Parameteres After TKA
|
||
Withdrawn |
NCT04976972 -
A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation
|
N/A | |
Completed |
NCT05496205 -
A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT03850665 -
Comparison of Functional Outcome in Patients After Hip Arthroplasty Depending on Surgical Approach
|
N/A | |
Completed |
NCT02826902 -
Effect of Anesthesia on Quality of Recovery in Patients Undergoing Correctional Tibial Osteotomy - A Randomized Controlled Trial
|
N/A | |
Completed |
NCT04402502 -
Dynamic 4DCT to Examine Wrist Carpal Mechanics
|
N/A | |
Completed |
NCT02923700 -
Leukocyte-rich PRP vs Leukocyte-poor PRP for the Treatment of Knee Cartilage Degeneration: a Randomized Controlled Trial
|
Phase 4 | |
Completed |
NCT04564053 -
Study of Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Osteoarthritis Participants
|
Phase 1 | |
Completed |
NCT05070871 -
A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women
|
N/A | |
Not yet recruiting |
NCT05036174 -
Diphenhydramine Ointment for Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT02912429 -
Onlay vs. Inlay Patellofemoral Arthroplasty
|
N/A | |
Recruiting |
NCT02666443 -
Low Dose Dexamethasone in Supraclavicular Blocks
|
N/A | |
Active, not recruiting |
NCT02723929 -
Effects of tDCS and tUS on Pain Perception in OA of the Knee
|
||
Terminated |
NCT02820766 -
Journey II BCS CMS Total Knee System Compared to Other PS Total Knee Systems in PT Setting
|
N/A | |
Withdrawn |
NCT02921594 -
Kinematic Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties
|
N/A |