Clinical trial NCT03021096: Natural History of Pain After Shoulder Arthroplasty Conducted With Multimodal Analgesia
Official title: Natural History of Pain After Shoulder Arthroplasty Conducted With Multimodal Analgesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: TSA
Bruise
Pain, Postoperative
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2017-01-13
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing TSA for Osteoarthritis, Reverse, Anatomic procedures

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

Eligibility criteria: 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

Primary outcomes:
measure: Numeric Rating Scale Pain Scores at Post-operative Day 14
timeFrame: 14 days after surgery for each patient
Secondary outcomes:
measure: Numeric Rating Scale (NRS) Pain With Movement and at Rest.
timeFrame: Days 1 day (POD0), 3 days(POD3), 7 days(POD7) and 3 months(POD90) after surgery
measure: Opioid Consumption (in Past 24 Hours)
timeFrame: Days 1 day, 3 days, 7 days after surgery
measure: Opioid Related Symptom Distress Scale
timeFrame: Day 1 after surgery
measure: Range of Motion
timeFrame: Day 14 after surgery and 3 months after surgery
measure: Severity of Bruising
timeFrame: Day 14 after surgery
measure: Hospital Anxiety and Depression Scale
timeFrame: Day 1 after surgery
measure: PainOUT Questionnaire
timeFrame: Day 1 and 14 after surgery
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Day of Surgery
measure: Fibromyalgia Scale. a Lower Score is a Better Outcome.
timeFrame: Day of Surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Jacques YaDeau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.