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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; TSA; Bruise
• Intervention / Treatment: Other: Surveys

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

• Study Type: Observational
• Enrollment (Actual): 108

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing TSA for Osteoarthritis, Reverse, Anatomic procedures

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS Pain Scores	Quantifying patients' pain at a sub-acute time point after surgery	14 days after surgery for each patient

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS pain with movement and at rest		Days 1, 3, 7 and 3 months after surgery
Opioid and NSAID consumption (in past 24 hours)		Days 1, 3, 7 and 3 months after surgery
Total number of analgesic pills taken	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)	1 day, 3 days, 7 days, 14 days and 3 months after surgery
Opioid Related Symptom Distress Scale		Day 1 after surgery
Range of Motion	Measure the ability of shoulder movement from 0 to 180 degrees at these follow up visits with the surgeon after surgery.	Day 14 after surgery and 3 months after surgery
Incidence and Severity of Bruising	Surgeon will determine whether bruising occurred and if so, the size and severity of the bruise	Day 14 after surgery and 3 months after surgery
Hospital Anxiety and Depression Scale		Day 1 after surgery
PainOUT Questionnaire	Included satisfaction question	Day 1 and 14 after surgery
Pain catastrophizing Scale		Day of Surgery
Fibromyalgia Scale		Day of Surgery

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York

Publications and helpful links

General Publications

• Goon AK, Dines DM, Craig EV, Gordon MA, Goytizolo EA, Lin Y, Lin E, YaDeau JT. A clinical pathway for total shoulder arthroplasty-a pilot study. HSS J. 2014 Jul;10(2):100-6. doi: 10.1007/s11420-014-9381-0. Epub 2014 Mar 8.
• YaDeau JT, Gordon MA, Goytizolo EA, Lin Y, Fields KG, Goon AK, Holck G, Miu TW, Gulotta LV, Dines DM, Craig EV. Buprenorphine, Clonidine, Dexamethasone, and Ropivacaine for Interscalene Nerve Blockade: A Prospective, Randomized, Blinded, Ropivacaine Dose-Response Study. Pain Med. 2016 May;17(5):940-60. doi: 10.1093/pm/pnv010. Epub 2015 Dec 14.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 27, 2017
• Primary Completion (ACTUAL): December 18, 2017
• Study Completion (ACTUAL): March 22, 2018

Study Registration Dates

• First Submitted: January 3, 2017
• First Submitted That Met QC Criteria: January 11, 2017
• First Posted (ESTIMATE): January 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2016-0779