Clinical Trial: Natural History of Pain After Shoulder Arthroplasty Conducted With Multimodal Analgesia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Natural History of Pain After Shoulder Arthroplasty Conducted With Multimodal Analgesia

Brief 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 Summary:

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

Sponsor: Hospital for Special Surgery, New York

Current Primary Outcome: NRS Pain Scores [ Time Frame: 14 days after surgery for each patient ]

Quantifying patients' pain at a sub-acute time point after surgery


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • NRS pain with movement and at rest [ Time Frame: Days 1, 3, 7 and 3 months after surgery ]
  • Opioid and NSAID consumption (in past 24 hours) [ Time Frame: Days 1, 3, 7 and 3 months after surgery ]
  • Total number of analgesic pills taken [ Time Frame: 1 day, 3 days, 7 days, 14 days and 3 months after surgery ]
    Other analgesic usage - POD1, POD3, POD7, POD 14, 3 months. (Number of tablets of other analgesics used in past 24 hours, including acetaminophen, NSAIDs, COX2 inhibitors, gabapentin, pregabalin, muscle relaxants)
  • Opioid Related Symptom Distress Scale [ Time Frame: Day 1 after surgery ]
  • Range of Motion [ Time Frame: Day 14 after surgery and 3 months after surgery ]
    Measure the ability of shoulder movement from 0 to 180 degrees at these follow up visits with the surgeon after surgery.
  • Incidence and Severity of Bruising [ Time Frame: Day 14 after surgery and 3 months after surgery ]
    Surgeon will determine whether bruising occurred and if so, the size and severity of the bruise
  • Hospital Anxiety and Depression Scale [ Time Frame: Day 1 after surgery ]
  • PainOUT Questionnaire [ Time Frame: Day 1 and 14 after surgery ]
    Included satisfaction question
  • Pain catastrophizing Scale [ Time Frame: Day of Surgery ]
  • Fibromyalgia Scale [ Time Frame: Day of Surgery ]


Original Secondary Outcome: Same as current

Information By: Hospital for Special Surgery, New York

Dates:
Date Received: January 3, 2017
Date Started: January 27, 2017
Date Completion: February 2018
Last Updated: February 28, 2017
Last Verified: February 2017