Natural History of Pain After Shoulder Arthroplasty Conducted With Multimodal Analgesia (TSA)

Hospital for Special Surgery (HSS)

Status: Completed

Conditions: TSA; Bruise; Pain, Postoperative

Treatments: Other: Surveys

Study type: Observational

Funder types: Other

Identifiers

NCT03021096

2016-0779

Details and patient eligibility

About

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.

Full description

This is a pilot study, with the goals of

1. developing data for a subsequent randomized trials
2. describing the pain trajectory after total shoulder arthroplasty given comprehensive multimodal perioperative analgesia
3. gathering preliminary data about which shoulder arthroplasty patients are at high risk for moderate or severe postoperative pain (NRS with movement, POD14, moderate >= 4- 6; Gerbershagen 2011; severe >= 7-10, Krebs 2007) Potential factors include fibromyalgia score, catastrophizing score, anxiety/depression score, gender, preoperative opioid use
4. gathering preliminary data on the potential association between the predictors listed in (c) and NRS pain score with movement on POD 14.
5. estimating incidence and severity of postoperative bruising on POD 14

Enrollment: 108 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design