NCT03732456

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 19, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 6, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2020

Completed
Last Updated

June 12, 2020

Status Verified

June 1, 2020

Enrollment Period

1.8 years

First QC Date

November 2, 2018

Last Update Submit

June 11, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • Postoperative change in pain intensity (NRS pain scale)

    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)

    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

    Analgesic consumption over one week after the surgery

    Over one week

  • Postoperative functional level (QuickDASH questionnaire)

    The QuickDASH questionnaire includes questions about the symptoms and ability to do certain activities

    One week after surgery

Interventions

Usual care surgery (shoulder arthroscopy) and post-operative pain management protocol

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology, Interim Chairperson

Study Record Dates

First Submitted

November 2, 2018

First Posted

November 6, 2018

Study Start

July 19, 2018

Primary Completion

April 20, 2020

Study Completion

April 20, 2020

Last Updated

June 12, 2020

Record last verified: 2020-06

Locations