NCT03021096

Natural History of Pain After Shoulder Arthroplasty Conducted With Multimodal Analgesia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 108 (actual)
• Sponsor: Hospital for Special Surgery, New York · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• TSA
• Bruise
• Pain, Postoperative

Interventions

Type	Name	Description
OTHER	Surveys	The study is just using validated surveys to assess pain and mood states after surgery

Timeline

• Start date: 2017-01-27
• Primary completion: 2017-12-18
• Completion: 2018-03-22
• First posted: 2017-01-13
• Last updated: 2025-03-04
• Results posted: 2025-03-04

Locations

1 site across 1 country: United States