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

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

• 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
Numeric Rating Scale Pain Scores at Post-operative Day 14	Quantifying patients' pain at a sub-acute time point after surgery at rest and with movement. The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".	14 days after surgery for each patient

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Numeric Rating Scale (NRS) Pain With Movement and at Rest.	The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". A lower score is a better outcome.	Days 1 day (POD0), 3 days(POD3), 7 days(POD7) and 3 months(POD90) after surgery
Opioid Consumption (in Past 24 Hours)	Measured in milligrams taken. A lower consumption is a better outcome.	Days 1 day, 3 days, 7 days after surgery
Opioid Related Symptom Distress Scale	The Opioid-Related Symptom Distress Scale (ORSDS) is calculated by taking the average of the three symptom distress dimensions. Frequency will be assessed using a 4 point scale: 1, rarely 2, occasionally 3, frequently 4, almost constantly with 1 being the lowest and 4 being the highest. Severity is assessed using a 4 point scale: 1, slight 2, moderate 3, severe 4, very severe with 1 being the lowest and 4 being the highest. Bothersomeness is assessed using a 5 point scale: 1, not at all 2, a little bit 3, somewhat 4, quite a bit 5, very much with 1 being the lowest and 5 being the highest. A higher score indicates worse outcomes. The total score for each participant is calculated and the median score for all participants is reported.	Day 1 after surgery
Severity of Bruising	Surgeon will assess each individual patient to determine whether bruising occurred and if so, the size and severity of the bruise.	Day 14 after surgery
Hospital Anxiety and Depression Scale	The Hospital Anxiety and Depression Scale (HADS) measures anxiety and depression in a general medical population of patients. a lower score is a better outcome. Each item on the questionnaire is scored from 0-3 and a person's total score can ranged from 0 = normal and 21 = abnormal for either anxiety or depression. Scale range: 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case) A total score for each participant was calculated and then all participants' scores were averaged.	Day 1 after surgery
PainOUT Questionnaire	The PainOUT questionnaire assess pain intensity, quality of pain, and satisfaction with pain management. The questionnaire measured the following: Worst pain: On a 0-10 scale, where 0 means "no pain" and 10 means "worst possible pain". Higher scores reflect more severity.; Pain severity: On a scale 0-10, where 0 means "very unsatisfied" and 10 means "very satisfied". Higher scores means more satisfaction.; Interference with sleep: Rated on a 0-10 scale, where 0 means "does not interfere" and 10 means "completely interfere" A higher rating means more interference.; Nausea & Itching: Both rated on a 0-10 scale, where 0 means "none" and 10 means "severe". A higher rating means more severe.; Drowsiness: Rated on a 0-10 scale, where 0 means "not at all" and 10 means "extremely". A higher rating means more severe. Each question score for each participant was added up and divided by the total number of participants to obtain an average score of 0-10 at each timepoint.	Day 1 and 14 after surgery
Pain Catastrophizing Scale (PCS)	The pain catastrophizing scale (PCS) evaluates a person's pain experience by asking them how they feel and what they think about when they are in pain. The questionnaire uses a 5-point Likert scale, with answers ranging from 0 (never) to 4. (always). The total score is the sum of the individual item scores and ranges from 0 to 52. A lower score indicates a more positive outcome.	Day of Surgery
Fibromyalgia Scale. a Lower Score is a Better Outcome.	The symptom severity (SS) scale assesses four symptoms that are thought to be defining in a fibromyalgia diagnosis. The four symptoms assessed by the criteria are as follows: Fatigue; Waking from sleep feeling unrefreshed; Cognitive symptoms (including trouble concentrating, confusion, disorientation, and impaired comprehension); Somatic symptoms (physical sensations such as pain, dizziness, nausea, fainting, or bowel disorders) Each of the 4 symptoms is graded on a scale of 0 to 3, with 0 indicating no symptoms, 1 indicating mild symptoms, 2 indicating moderate symptoms, and 3 indicating severe symptoms. The sum of the scores for each of the 4 symptoms is summed to produce the SS total score. The SS total score has a minimum score of 0 and a maximum score of 12. The higher score means worst outcome. The sum score for each participant is calculated and then the average score for all participants is reported.	Day of Surgery

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Investigators: Principal Investigator: Jacques YaDeau, MD, PhD, Hospital for Special Surgery, New York

Publications and helpful links

General Publications

• 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.
• 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.

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 (Estimated): January 13, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

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