Natural History of Pain After Shoulder Arthroplasty Conducted With Multimodal Analgesia

Pain, Postoperative Clinical Trial

— TSA Pain  

Official title:

Natural History of Pain After Shoulder Arthroplasty Conducted With Multimodal Analgesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03021096
• Other study ID #: 2016-0779
• Status: Completed
• Start date: January 27, 2017
• Est. completion date: March 22, 2018

Study information

• Verified date: April 2022
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: March 22, 2018
• Est. primary completion date: December 18, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bruise
• Pain, Postoperative
• TSA

Intervention

Other:
• Surveys
The study is just using validated surveys to assess pain and mood states after surgery

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NRS Pain Scores	Quantifying patients' pain at a sub-acute time point after surgery	14 days after surgery for each patient
Secondary	NRS pain with movement and at rest		Days 1, 3, 7 and 3 months after surgery
Secondary	Opioid and NSAID consumption (in past 24 hours)		Days 1, 3, 7 and 3 months after surgery
Secondary	Total number of analgesic pills taken	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)	1 day, 3 days, 7 days, 14 days and 3 months after surgery
Secondary	Opioid Related Symptom Distress Scale		Day 1 after surgery
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.	Day 14 after surgery and 3 months after surgery
Secondary	Incidence and Severity of Bruising	Surgeon will determine whether bruising occurred and if so, the size and severity of the bruise	Day 14 after surgery and 3 months after surgery
Secondary	Hospital Anxiety and Depression Scale		Day 1 after surgery
Secondary	PainOUT Questionnaire	Included satisfaction question	Day 1 and 14 after surgery
Secondary	Pain catastrophizing Scale		Day of Surgery
Secondary	Fibromyalgia Scale		Day of Surgery