Bruise, Pain, Postoperative, TSA
Conditions
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
Interventions
OTHERSurveys
The study is just using validated surveys to assess pain and mood states after surgery
Sponsors
Hospital for Special Surgery, New York
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Total Shoulder Surgery Patients In the operating room, patients received intravenous sedation of up to 5 mg of midazolam, 10 to 20 mg of ketamine, and propofol as deemed appropriate. An ultrasound-guided interscalene peripheral nerve block was performed in the operating room, before surgery, using 25 mL bupivacaine, 0.5%, with added 100 mg clonidine, 2 mg preservative free dexamethasone, and 150 mg buprenorphine. During the procedure, patients received either intravenous sedation with a propofol infusion, or general anesthesia with propofol induction, either laryngeal mask airway or endotracheal tube insertion, and general anesthesia maintenance with titrated propofol and 1% sevoflurane. For the intravenous sedation and general anesthesia groups, patients received ketamine (total of 50 mg), ondansetron (4 mg), famotidine (20 mg), dexamethasone (4 mg) and ketorolac (15 mg) during surgery. For postoperative analgesia, patients received intravenous acetaminophen (1000 mg every 6 hours, four total doses) and intravenous ketorolac (15 mg every 8 hours, for three postoperative doses in addition to one dose in the operating room) followed by oral acetaminophen (650 mg every 6 hours for 3 days) and oral meloxicam (7.5-15 mg per day). Oral opioids were available on demand, based on patient description of pain to the nursing staff as mild, moderate, or severe. Each patient also received intravenous patient-controlled analgesia of hydromorphone. | 102 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Protocol Violation | 2 |
Baseline characteristics
| Characteristic | Total Shoulder Surgery Patients | — |
|---|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 48 Participants | — |
| Sex: Female, Male Male | 54 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 108 |
| other Total, other adverse events | 0 / 108 |
| serious Total, serious adverse events | 0 / 108 |
Outcome results
Primary
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.
Time frame: 14 days after surgery for each patient
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Shoulder Surgery Patients | Numeric Rating Scale Pain Scores at Post-operative Day 14 | NRS at rest | 1.6 score on a scale | Standard Deviation 1.8 |
| Total Shoulder Surgery Patients | Numeric Rating Scale Pain Scores at Post-operative Day 14 | NRS with movement | 3.1 score on a scale | Standard Deviation 2.3 |
Secondary
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: 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.
Time frame: Day of Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Shoulder Surgery Patients | Fibromyalgia Scale. a Lower Score is a Better Outcome. | 5.5 score on a scale | Standard Deviation 3.4 |
Secondary
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.
Time frame: Day 1 after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Shoulder Surgery Patients | Hospital Anxiety and Depression Scale | Anxiety | 4.1 score on a scale | Standard Deviation 3.3 |
| Total Shoulder Surgery Patients | Hospital Anxiety and Depression Scale | Depression | 3.9 score on a scale | Standard Deviation 2.7 |
Secondary
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.
Time frame: Days 1 day (POD0), 3 days(POD3), 7 days(POD7) and 3 months(POD90) after surgery
Population: some patients did not fill out questionnaire or were lost to follow up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Shoulder Surgery Patients | Numeric Rating Scale (NRS) Pain With Movement and at Rest. | NRS POD90 with movement | 1.7 score on a scale | Standard Deviation 2.2 |
| Total Shoulder Surgery Patients | Numeric Rating Scale (NRS) Pain With Movement and at Rest. | NRS POD1 at rest | 1.6 score on a scale | Standard Deviation 2.1 |
| Total Shoulder Surgery Patients | Numeric Rating Scale (NRS) Pain With Movement and at Rest. | NRS POD1 with movement | 2.7 score on a scale | Standard Deviation 3 |
| Total Shoulder Surgery Patients | Numeric Rating Scale (NRS) Pain With Movement and at Rest. | NRS POD3 at rest | 2.8 score on a scale | Standard Deviation 3.3 |
| Total Shoulder Surgery Patients | Numeric Rating Scale (NRS) Pain With Movement and at Rest. | NRS POD3 with movement | 4.7 score on a scale | Standard Deviation 2.4 |
| Total Shoulder Surgery Patients | Numeric Rating Scale (NRS) Pain With Movement and at Rest. | NRS POD7 at rest | 2.3 score on a scale | Standard Deviation 2.4 |
| Total Shoulder Surgery Patients | Numeric Rating Scale (NRS) Pain With Movement and at Rest. | NRS POD7 with movement | 3.9 score on a scale | Standard Deviation 2.3 |
| Total Shoulder Surgery Patients | Numeric Rating Scale (NRS) Pain With Movement and at Rest. | NRS POD90 at rest | 0.8 score on a scale | Standard Deviation 1.7 |
Secondary
Opioid Consumption (in Past 24 Hours)
Measured in milligrams taken. A lower consumption is a better outcome.
Time frame: Days 1 day, 3 days, 7 days after surgery
Population: some patients were lost to follow up.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Total Shoulder Surgery Patients | Opioid Consumption (in Past 24 Hours) | POD1 | 17.5 oral morphine equivalents (mg) |
| Total Shoulder Surgery Patients | Opioid Consumption (in Past 24 Hours) | POD3 | 30 oral morphine equivalents (mg) |
| Total Shoulder Surgery Patients | Opioid Consumption (in Past 24 Hours) | POD7 | 10 oral morphine equivalents (mg) |
Secondary
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.
Time frame: Day 1 after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Total Shoulder Surgery Patients | Opioid Related Symptom Distress Scale | 0.3 score on a scale |
Secondary
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.
Time frame: Day of Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Shoulder Surgery Patients | Pain Catastrophizing Scale (PCS) | 12 score on a scale | Standard Deviation 11.9 |
Secondary
PainOUT Questionnaire
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.
Time frame: Day 1 and 14 after surgery
Population: some patients were lost to follow up.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Total Shoulder Surgery Patients | PainOUT Questionnaire | POD1 - Worst pain | 2 score on a scale |
| Total Shoulder Surgery Patients | PainOUT Questionnaire | POD14 - Worst pain | 4 score on a scale |
| Total Shoulder Surgery Patients | PainOUT Questionnaire | POD1 - Pain severity | 0 score on a scale |
| Total Shoulder Surgery Patients | PainOUT Questionnaire | POD14 - Pain severity | 0 score on a scale |
| Total Shoulder Surgery Patients | PainOUT Questionnaire | POD1 - Interference with sleep | 0 score on a scale |
| Total Shoulder Surgery Patients | PainOUT Questionnaire | POD14 - Interference with sleep | 0 score on a scale |
| Total Shoulder Surgery Patients | PainOUT Questionnaire | POD1 - Nausea | 0 score on a scale |
| Total Shoulder Surgery Patients | PainOUT Questionnaire | POD14 - Nausea | 0 score on a scale |
| Total Shoulder Surgery Patients | PainOUT Questionnaire | POD1 - Itching | 0 score on a scale |
| Total Shoulder Surgery Patients | PainOUT Questionnaire | POD14 - Itching | 0 score on a scale |
| Total Shoulder Surgery Patients | PainOUT Questionnaire | POD1 - Drowsiness | 0 score on a scale |
| Total Shoulder Surgery Patients | PainOUT Questionnaire | POD14 - Drowsiness | 0 score on a scale |
Secondary
Range of Motion
Measure the ability of shoulder movement from 0 to 180 degrees at these follow up visits with the surgeon after surgery.
Time frame: Day 14 after surgery and 3 months after surgery
Population: some patients were lost to follow up or did not answer questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Shoulder Surgery Patients | Range of Motion | 14 days after surgery extension | 15.8 degrees | Standard Deviation 5.8 |
| Total Shoulder Surgery Patients | Range of Motion | 3 months after surgery extension | 35 degrees | Standard Deviation 21.2 |
Secondary
Severity of Bruising
Surgeon will assess each individual patient to determine whether bruising occurred and if so, the size and severity of the bruise.
Time frame: Day 14 after surgery
Population: some patients were lost to follow up or did not complete questionnaire. 32 people were reported to have bruising and size (in centimeters) of their bruises were measured.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Shoulder Surgery Patients | Severity of Bruising | 1.5 cm | Standard Deviation 1.9 |