Natural History of Pain After Shoulder Arthroplasty Conducted With Multimodal Analgesia

Completed

Conditions: TSA
Pain, Postoperative
Bruise

Registration Number: NCT03021096

Lead Sponsor: Hospital for Special Surgery, New York

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 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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 108

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Numeric Rating Scale Pain Scores at Post-operative Day 14	14 days after surgery for each patient	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".

Secondary Outcome Measures

Name	Time	Method
Opioid Related Symptom Distress Scale	Day 1 after surgery	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.
Range of Motion	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.
Severity of Bruising	Day 14 after surgery	Surgeon will assess each individual patient to determine whether bruising occurred and if so, the size and severity of the bruise.
Hospital Anxiety and Depression Scale	Day 1 after surgery	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.
PainOUT Questionnaire	Day 1 and 14 after surgery	The PainOUT questionnaire assess pain intensity, quality of pain, and satisfaction with pain management. The questionnaire measured the following: 1. Worst pain: On a 0-10 scale, where 0 means "no pain" and 10 means "worst possible pain". Higher scores reflect more severity. 2. Pain severity: On a scale 0-10, where 0 means "very unsatisfied" and 10 means "very satisfied". Higher scores means more satisfaction. 3. 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. 4. Nausea \& Itching: Both rated on a 0-10 scale, where 0 means "none" and 10 means "severe". A higher rating means more severe. 5. 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.
Fibromyalgia Scale. a Lower Score is a Better Outcome.	Day of Surgery	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: 1. Fatigue 2. Waking from sleep feeling unrefreshed 3. Cognitive symptoms (including trouble concentrating, confusion, disorientation, and impaired comprehension) 4. 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.
Numeric Rating Scale (NRS) Pain With Movement and at Rest.	Days 1 day (POD0), 3 days(POD3), 7 days(POD7) and 3 months(POD90) after surgery	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.
Opioid Consumption (in Past 24 Hours)	Days 1 day, 3 days, 7 days after surgery	Measured in milligrams taken. A lower consumption is a better outcome.
Pain Catastrophizing Scale (PCS)	Day of Surgery	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.