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NCT03732456 Clinical Trial

Post-operative Pain After Shoulder Surgery

Pain, Shoulder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03732456
Other study ID # BIO-2018-0083
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 19, 2018
Est. completion date April 20, 2020

Study information
Verified date June 2020
Source American University of Beirut Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 146
Est. completion date April 20, 2020
Est. primary completion date April 20, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Shoulder surgery and post-op pharmacological treatment
Usual care surgery (shoulder arthroscopy) and post-operative pain management protocol

Locations
Country Name City State
Lebanon American University of Beirut Medical Center Beirut

Sponsors (1)
Lead Sponsor Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Postoperative analgesic consumption Analgesic consumption over one week after the surgery Over one week
Primary Postoperative functional level (QuickDASH questionnaire) The QuickDASH questionnaire includes questions about the symptoms and ability to do certain activities One week after surgery
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