Natural History of Pain After Shoulder Arthroplasty Conducted With Multimodal Analgesia

NCT03021096 | Completed Results DMC

• 1 other identifier: 2016-0779
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

TSA; Bruise; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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".

  14 days after surgery for each patient

Secondary Outcomes (9)

• 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

• Opioid Consumption (in Past 24 Hours)

  Days 1 day, 3 days, 7 days after surgery

• Opioid Related Symptom Distress Scale

  Day 1 after surgery

• Range of Motion

  Day 14 after surgery and 3 months after surgery

• Severity of Bruising

  Day 14 after surgery

Interventions

Surveys OTHER

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing TSA for Osteoarthritis, Reverse, Anatomic procedures

You may qualify if:

• 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

You may not qualify if:

• Incapable to provide informed consent
• Contraindications for regional anesthesia (anticoagulation, infection at injection site)
• Patients undergoing TSA for Trauma or Rheumatoid Arthritis
• Conversion of hemiarthroplasty to TSA
• Planned use of tranexamic acid

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related 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.

  PMID: 25050091 BACKGROUND

• 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.

  PMID: 26814246 BACKGROUND

MeSH Terms

Conditions

Contusions; Pain, Postoperative

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Dr Jacques Yadeau
• Organization: Hospital for Special Surgery, Anesthesiology

Yadeauj@hss.edu

2126061036

Study Officials

• Jacques YaDeau, MD, PhD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: January 13, 2017
• Study Start: January 27, 2017
• Primary Completion: December 18, 2017
• Study Completion: March 22, 2018
• Last Updated: March 4, 2025
• Results First Posted: March 4, 2025

Record last verified: 2025-01

Locations

US (1)