Natural History of Pain After Shoulder Arthroplasty Conducted With Multimodal Analgesia

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-27

Study Completion Date

2018-03-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prediction Of Post Operative Pain Following Arthroscopic Shoulder Surgery

NCT01351363

Arthroscopic Shoulder Surgery Pain Threshold

COMPLETED NA

A Study of the Incidence of Post-Thoracotomy Shoulder Pain

NCT00373984

Post-thoracotomy Shoulder Pain

COMPLETED

Postoperative Pain After Ambulatory Arthroscopic Shoulder Surgery

NCT02924519

Chronic Postoperative Pain

UNKNOWN

Pain Sensitivity and Outcome in Arthroscopic Shoulder Surgery

NCT01621555

Anomaly; Shoulder

UNKNOWN

Post-operative Pain After Shoulder Surgery

NCT03732456

Pain, Shoulder

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

TSA Bruise Pain, Postoperative

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Surveys

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes