Phase 4
Completed N=80
Analgesia After Total Shoulder Arthroplasty
Total Shoulder Arthroplasty
Source: ClinicalTrials.gov NCT01782872 ↗
Enrolled (actual)
80
Serious AEs
0.0%
Results posted
May 2016
Primary outcomePrimary: Numeric Rating Scale (NRS) Pain Score With Movement — 4.5; 3.4; 4.2; 4.9 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to determine which medication(s) should be included in the interscalene nerve block (an injection of local anesthetic [numbing medicine] near nerves in the shoulder) for patients undergoing total shoulder arthroplasty (shoulder replacement). The ideal nerve block would reduce pain after shoulder surgery without causing a great deal of muscle weakness.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numeric Rating Scale (NRS) Pain Score With Movement |
4.5; 3.4; 4.2; 4.9 | — |
| SECONDARY Duration of Analgesia From Interscalene Nerve Block |
21.3; 16.8; 18.2; 16.4 | — |
| SECONDARY Numeric Rating Scale (NRS) Pain Scores at Rest |
3.0; 3.2; 3.0; 4.9 | — |
| SECONDARY Middle Deltoid |
2.8; 1.5; 2.2; 1.8 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with osteoarthritis
- Primary total shoulder arthroplasty
- Age 18 to 80 years old
- Planned use of general anesthesia
- Planned use of a brachial plexus nerve block for postoperative analgesia
- Ability to follow study protocol
Exclusion Criteria
- Patients younger than 18 years old and older than 80
- Allergy or intolerance to one of the study medications
- Patients with an American Society of Anesthesiologists (ASA) physical status of IV
- Patients with insulin-dependent diabetes
- Patients with hepatic (liver) failure
- Patients with chronic renal (kidney) failure
- Bradycardia (heart rate < 50) or hypotension (systolic blood pressure < 90 mmHg)
- Chronic opioid use (taking opioids for longer than 3 months) (or active diagnosis of complex regional pain syndrome [CRPS]/reflex sympathetic dystrophy [RSD])
- Lack of English fluency
Data sourced from ClinicalTrials.gov (NCT01782872). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.