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NCT Number: NCT03021096

Natural History of Pain After Shoulder Arthroplasty Conducted With Multimodal Analgesia

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.

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Key information

Conditions

TSA Bruise Contusions Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital for Special Surgery

New York, 10021, United States

About this study

This is a pilot study, with the goals of

  • developing data for a subsequent randomized trials
  • describing the pain trajectory after total shoulder arthroplasty given comprehensive multimodal perioperative analgesia
  • 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
  • gathering preliminary data on the potential association between the predictors listed in (c) and NRS pain score with movement on POD 14.
  • estimating incidence and severity of postoperative bruising on POD 14

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surveys

Other

The study is just using validated surveys to assess pain and mood states after surgery

Primary outcomes

  1. Numeric Rating Scale Pain Scores at Post-operative Day 14

    Time frame: 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 outcomes

  1. Numeric Rating Scale (NRS) Pain With Movement and at Rest.

    Time frame: 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.

  2. Opioid Consumption (in Past 24 Hours)

    Time frame: Days 1 day, 3 days, 7 days after surgery

    Measured in milligrams taken. A lower consumption is a better outcome.

  3. Opioid Related Symptom Distress Scale

    Time frame: 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.

  4. 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.

  5. Severity of Bruising

    Time frame: 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.

  6. Hospital Anxiety and Depression Scale

    Time frame: 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.

  7. PainOUT Questionnaire

    Time frame: 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:

    • 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.

  8. Pain Catastrophizing Scale (PCS)

    Time frame: 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.

  9. Fibromyalgia Scale. a Lower Score is a Better Outcome.

    Time frame: 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:

    • 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.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Acronym: TSA

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jan 13, 2017
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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