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

• Sponsor: Hospital for Special Surgery, New York (Other)
• Overall Status: Completed
• CT.gov ID: NCT03021096
• Collaborator: (none)
• Enrollment: 108
• Location: 1
• Actual Duration (Months): 13.8
• Patients Per Site Per Month: 7.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
TSA; Bruise; Pain, Postoperative	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 Design

• Study Type: Observational
• Actual Enrollment: 108 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Natural History of Pain After Shoulder Arthroplasty Conducted With Multimodal Analgesia
• Actual Study Start Date: Jan 27, 2017
• Actual Primary Completion Date: Dec 18, 2017
• Actual Study Completion Date: Mar 22, 2018

Outcome Measures

Primary Outcome Measures

1. NRS Pain Scores [14 days after surgery for each patient]

   Quantifying patients' pain at a sub-acute time point after surgery

Secondary Outcome Measures

1. NRS pain with movement and at rest [Days 1, 3, 7 and 3 months after surgery]

2. Opioid and NSAID consumption (in past 24 hours) [Days 1, 3, 7 and 3 months after surgery]

3. Total number of analgesic pills taken [1 day, 3 days, 7 days, 14 days and 3 months after surgery]

   Other analgesic usage - POD1, POD3, POD7, POD 14, 3 months. (Number of tablets of other analgesics used in past 24 hours, including acetaminophen, NSAIDs, COX2 inhibitors, gabapentin, pregabalin, muscle relaxants)

4. Opioid Related Symptom Distress Scale [Day 1 after surgery]

5. 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.

6. Incidence and Severity of Bruising [Day 14 after surgery and 3 months after surgery]

   Surgeon will determine whether bruising occurred and if so, the size and severity of the bruise

7. Hospital Anxiety and Depression Scale [Day 1 after surgery]

8. PainOUT Questionnaire [Day 1 and 14 after surgery]

   Included satisfaction question

9. Pain catastrophizing Scale [Day of Surgery]

10. Fibromyalgia Scale [Day of Surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital for Special Surgery	New York	New York	United States	10021

Sponsors and Collaborators

• Hospital for Special Surgery, New York

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Hospital for Special Surgery, New York
• ClinicalTrials.gov Identifier: NCT03021096
• Other Study ID Numbers: 2016-0779
• First Posted: Jan 13, 2017
• Last Update Posted: Apr 14, 2022
• Last Verified: Apr 1, 2022

• Additional relevant MeSH terms: Pain, Postoperative

Study Results

No Results Posted as of Apr 14, 2022