Total Shoulder Arthroplasty
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Hospital for Special Surgery, New York
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for primary total shoulder arthroplasty * Age 18 to 80 years old * Planned use of general anesthesia via laryngeal mask airway (LMA) and peripheral nerve block * Ability to follow study protocol * Patients with American Society of Anesthesiologists (ASA) physical status of I, II or III
Exclusion criteria
* Patients younger than 18 years old and older than 80 * Patients not intending to receive general anesthesia and peripheral nerve block * Allergy or intolerance to one of the study medications * Patients with an ASA of IV * Hepatic or renal insufficiency * Chronic opioid use (taking opioids for longer than 3 months)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anterior Deltoid Strength | 2 days postoperatively | Anterior deltoid strength as measured by a dynamometer. Percentage change in measure as compared to post-surgery (with post-surgery measure at 0%). |
| Hand Grip Strength | 2 days postoperatively | Hand grip strength as measured by a dynamometer. Percentage change in measure as compared to post-surgery (with post-surgery measure at 0%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Reduced Sensation in a Dermatome | 2 days postoperatively | Pin-prick sensation assessed. |
| Numeric Rating Scale (NRS) Pain Scores With Movement | 2 days postoperatively | NRS pain scores (0-10; 0 = no pain, 10 = worst pain possible) assessed. |
| Total Oral Opioid Intake in 48hrs | 0-48hrs | Opioid Usage |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Total Shoulder Arthroplasty Patients | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Total Shoulder Arthroplasty Patients |
|---|---|
| Age, Continuous | 72 years STANDARD_DEVIATION 4 |
| Body Mass Index Normal | 1 participants |
| Body Mass Index Obese | 6 participants |
| Body Mass Index Overweight | 3 participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
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%).
Time frame: 2 days postoperatively
Population: One participant declined assessment due to soreness in the shoulder muscle.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Total Shoulder Arthroplasty Patients | Anterior Deltoid Strength | 77 percent |
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%).
Time frame: 2 days postoperatively
Population: One participant declined assessment due to soreness in the shoulder muscle.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Total Shoulder Arthroplasty Patients | Hand Grip Strength | 90 percent |
Secondary
Number of Participants With Reduced Sensation in a Dermatome
Pin-prick sensation assessed.
Time frame: 2 days postoperatively
Population: Dermatomes could not be assessed for one patient due to sedation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Shoulder Arthroplasty Patients | Number of Participants With Reduced Sensation in a Dermatome | 8 participants |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Total Shoulder Arthroplasty Patients | Numeric Rating Scale (NRS) Pain Scores With Movement | 0.8 units on a scale |
Secondary
Total Oral Opioid Intake in 48hrs
Opioid Usage
Time frame: 0-48hrs
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Shoulder Arthroplasty Patients | Total Oral Opioid Intake in 48hrs | 52.3 mg | Standard Deviation 32.7 |