N/A
N=108
Natural History of Pain After Shoulder Arthroplasty Conducted With Multimodal Analgesia
TSA · Bruise · Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT03021096 ↗Enrolled (actual)
108
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Numeric Rating Scale Pain Scores at Post-operative Day 14 — 1.6; 3.1 score on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Surveys (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hospital for Special Surgery, New York
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numeric Rating Scale Pain Scores at Post-operative Day 14 |
1.6; 3.1 | — |
| SECONDARY Numeric Rating Scale (NRS) Pain With Movement and at Rest. |
1.6; 2.7; 2.8; 4.7; 2.3; 3.9 | — |
| SECONDARY Opioid Consumption (in Past 24 Hours) |
17.5; 30; 10 | — |
| SECONDARY Opioid Related Symptom Distress Scale |
0.3 | — |
| SECONDARY Range of Motion |
15.8; 35 | — |
| SECONDARY Severity of Bruising |
1.5 | — |
| SECONDARY Hospital Anxiety and Depression Scale |
4.1; 3.9 | — |
| SECONDARY PainOUT Questionnaire |
2; 4; 0; 0; 0; 0 | — |
| SECONDARY Pain Catastrophizing Scale (PCS) |
12 | — |
| SECONDARY Fibromyalgia Scale. a Lower Score is a Better Outcome. |
5.5 | — |
Summary
This study aims to identify the timeline of pain following total shoulder replacement with the goal of developing data for a subsequent randomized trial. The investigators believe that with using HSS's current protocol, many patients have postoperative pain that is no worse than their preoperative pain. Previous HSS anesthesia protocols for total shoulder arthroplasty patients have not formally followed patients past their hospital discharge, and the investigators believe that some patients do experience moderate to severe subacute postoperative pain. Therefore, this study's primary outcome is to look at the numeric pain scores at 14 days after surgery. Future studies will look at measures of preventing bruising and subsequent pain after shoulder replacement.
Eligibility Criteria
Inclusion Criteria
- All patients eligible for the standardized anesthetic for TSA
- Patients who are capable to provide informed consent and answer questions in English (Study involves questionnaires validated in English)
- Age 18-80
Exclusion Criteria
- Incapable to provide informed consent
- Contraindications for regional anesthesia (anticoagulation, infection at injection site)
- Patients undergoing TSA for Trauma or Rheumatoid Arthritis
- Revision TSA (previous non-TSA surgery is not an exclusion)
- Conversion of hemiarthroplasty to TSA
- Planned use of tranexamic acid
Data sourced from ClinicalTrials.gov (NCT03021096). 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.