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Total shoulder arthroplasty (shoulder replacement) can cause severe postoperative pain. Commonly, patients receive general anesthesia with interscalene block (injection of local anesthetic or numbing medicine near nerves in the shoulder) during surgery. As a result of the interscalene block, patients often experience sensory and motor blockade. The purpose of this study is to determine the effects of the interscalene block on the anterior deltoid muscle and hand grip strength after total shoulder arthroplasty.
Total shoulder arthroplasty can cause severe postoperative pain. Pain management includes general anesthesia with interscalene block during surgery and intravenous (IV) hydromorphone patient controlled analgesia (PCA) and oral opioid analgesics given after surgery. Side effects, such as motor blockade, may impair participation in physical therapy and diminish patient satisfaction. In order to prepare for a future study that will examine what mixtures of adjuncts/additives will best prevent recovery room pain and minimize motor blockade, the investigators are conducting this pilot study to collect preliminary data on current practice. The investigators believe the current regimen will provide adequate pain relief, but may cause extensive motor blockade and reduce patients' muscle strength after surgery.
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| Measure | Description | Time Frame |
|---|---|---|
| Anterior Deltoid Strength | Anterior deltoid strength as measured by a dynamometer. Percentage change in measure as compared to post-surgery (with post-surgery measure at 0%). | 2 days postoperatively |
| Hand Grip Strength | Hand grip strength as measured by a dynamometer. Percentage change in measure as compared to post-surgery (with post-surgery measure at 0%). | 2 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Reduced Sensation in a Dermatome | Pin-prick sensation assessed. | 2 days postoperatively |
| Numeric Rating Scale (NRS) Pain Scores With Movement | NRS pain scores (0-10; 0 = no pain, 10 = worst pain possible) assessed. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients 18-80 years old who are undergoing primary total shoulder arthroplasty.
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| Name | Affiliation | Role |
|---|---|---|
| Jacques T YaDeau, MD, PhD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Total Shoulder Arthroplasty Patients |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Shoulder Arthroplasty Patients |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Anterior Deltoid Strength | Anterior deltoid strength as measured by a dynamometer. Percentage change in measure as compared to post-surgery (with post-surgery measure at 0%). | One participant declined assessment due to soreness in the shoulder muscle. | Posted | Median | Inter-Quartile Range | percent | 2 days postoperatively |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Total Shoulder Arthroplasty Patients |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jacques YaDeau | Hospital for Special Surgery | 2127742224 | yadeauj@hss.edu |
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| 2 days postoperatively |
| Total Oral Opioid Intake in 48hrs | Opioid Usage | 0-48hrs |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index | Number | participants |
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| Primary | Hand Grip Strength | Hand grip strength as measured by a dynamometer. Percentage change in measure as compared to post-surgery (with post-surgery measure at 0%). | One participant declined assessment due to soreness in the shoulder muscle. | Posted | Median | Inter-Quartile Range | percent | 2 days postoperatively |
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| Secondary | Number of Participants With Reduced Sensation in a Dermatome | Pin-prick sensation assessed. | Dermatomes could not be assessed for one patient due to sedation | Posted | Number | participants | 2 days postoperatively |
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| Secondary | Numeric Rating Scale (NRS) Pain Scores With Movement | NRS pain scores (0-10; 0 = no pain, 10 = worst pain possible) assessed. | Posted | Median | Inter-Quartile Range | units on a scale | 2 days postoperatively |
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| Secondary | Total Oral Opioid Intake in 48hrs | Opioid Usage | Posted | Mean | Standard Deviation | mg | 0-48hrs |
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| 0 |
| 10 |
| 0 |
| 10 |
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