An observational study in Total Shoulder Arthroplasty, sponsored by Hospital for Special Surgery, New York. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-03-31.
Sponsored by Hospital for Special Surgery, New York · Observational
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.
Hospital for Special Surgery, New York is the lead sponsor of 217 studies on the registry; 39 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 20 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients 18-80 years old who are undergoing primary total shoulder arthroplasty.
Exclusion Criteria:
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%).
Time frame: 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%).
Time frame: 2 days postoperatively
Number of Participants With Reduced Sensation in a Dermatome
Pin-prick sensation assessed.
Time frame: 2 days postoperatively
Numeric Rating Scale (NRS) Pain Scores With Movement
NRS pain scores (0-10; 0 = no pain, 10 = worst pain possible) assessed.
Time frame: 2 days postoperatively
Total Oral Opioid Intake in 48hrs
Opioid Usage
Time frame: 0-48hrs
| Milestone | Total Shoulder Arthroplasty Patients |
|---|---|
| Started | 10 |
| Completed | 10 |
| Not completed | 0 |
Anterior deltoid strength as measured by a dynamometer. Percentage change in measure as compared to post-surgery (with post-surgery measure at 0%).
| percent | Total Shoulder Arthroplasty Patients |
|---|---|
| Anterior Deltoid Strength | 77 (52 to 119) |
Hand grip strength as measured by a dynamometer. Percentage change in measure as compared to post-surgery (with post-surgery measure at 0%).
| percent | Total Shoulder Arthroplasty Patients |
|---|---|
| Hand Grip Strength | 90 (76 to 99) |
Pin-prick sensation assessed.
| participants | Total Shoulder Arthroplasty Patients |
|---|---|
| Number of Participants With Reduced Sensation in a Dermatome | 8 |
NRS pain scores (0-10; 0 = no pain, 10 = worst pain possible) assessed.
| units on a scale | Total Shoulder Arthroplasty Patients |
|---|---|
| Numeric Rating Scale (NRS) Pain Scores With Movement | 0.8 (0 to 1.5) |
Opioid Usage
| mg | Total Shoulder Arthroplasty Patients |
|---|---|
| Total Oral Opioid Intake in 48hrs | 52.3 ± 32.7 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Total Shoulder Arthroplasty Patients | — | 0/10 (0%) | 0/10 (0%) |
| Age, Continuous(years) | Total Shoulder Arthroplasty Patients |
|---|---|
| Mean | 72 ± 4 |
| Sex: Female, Male(Participants) | Total Shoulder Arthroplasty Patients |
|---|---|
| Female | 5 |
| Male | 5 |
| Region of Enrollment(participants) | Total Shoulder Arthroplasty Patients |
|---|---|
| United States | 10 |
| Body Mass Index(participants) | Total Shoulder Arthroplasty Patients |
|---|---|
| Normal | 1 |
| Overweight | 3 |
| Obese | 6 |
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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Hospital for Special Surgery, New York