Post-operative Pain After Shoulder Surgery

June 11, 2020 updated by: Dr. Marie Awad, American University of Beirut Medical Center

Predictors of Post-operative Pain in Shoulder Surgery, a Prospective Observational Study

A prospective observational study conducted at the American University of Beirut Medical center that targets patients undergoing shoulder surgeries. It is conducted to to prospectively collect patient, surgery and anesthesia-related variables and perform correlation studies with postoperative pain severity, patients' satisfaction and analgesic consumption following shoulder surgery.

In addition, identifying predictors for postoperative pain will contribute to adjust pain management protocols as per surgical and patients' factors.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

146

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Beirut, Lebanon
        • American University of Beirut Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients older than 18 years of age and admitted to the American University of Beirut Medical Center for any shoulder surgery

Description

Inclusion Criteria:

  • All adult patients > 18 years old admitted to the American University of Beirut - Medical Center for any shoulder surgery

Exclusion Criteria:

  • Patients suffering of opioids addiction (or previous history of addiction) or drug abuse.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative change in pain intensity (NRS pain scale)
Time Frame: 24 hours, 3 days and one week after surgery
Asses the change in pain intensity after the surgery using the NRS pain score (0-10)
24 hours, 3 days and one week after surgery
Postoperative change in satisfaction with pain management (NRS satisfaction scale)
Time Frame: 24 hours, 3 days and one week after surgery
Asses the change in satisfaction with the pain management protocol using the NRS satisfaction score (0-10)
24 hours, 3 days and one week after surgery
Postoperative analgesic consumption
Time Frame: Over one week
Analgesic consumption over one week after the surgery
Over one week
Postoperative functional level (QuickDASH questionnaire)
Time Frame: One week after surgery
The QuickDASH questionnaire includes questions about the symptoms and ability to do certain activities
One week after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 19, 2018

Primary Completion (ACTUAL)

April 20, 2020

Study Completion (ACTUAL)

April 20, 2020

Study Registration Dates

First Submitted

November 2, 2018

First Submitted That Met QC Criteria

November 5, 2018

First Posted (ACTUAL)

November 6, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 12, 2020

Last Update Submitted That Met QC Criteria

June 11, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain, Shoulder

Clinical Trials on Shoulder surgery and post-op pharmacological treatment

3
Subscribe