Post-operative Pain After Shoulder Surgery

• Sponsor: American University of Beirut Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03732456
• Collaborator: (none)
• Enrollment: 146
• Location: 1
• Actual Duration (Months): 21.1
• Patients Per Site Per Month: 6.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Shoulder	Procedure: Shoulder surgery and post-op pharmacological treatment

Study Design

• Study Type: Observational
• Actual Enrollment: 146 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Predictors of Post-operative Pain in Shoulder Surgery, a Prospective Observational Study
• Actual Study Start Date: Jul 19, 2018
• Actual Primary Completion Date: Apr 20, 2020
• Actual Study Completion Date: Apr 20, 2020

Outcome Measures

Primary Outcome Measures

1. Postoperative change in pain intensity (NRS pain scale) [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)

2. Postoperative change in satisfaction with pain management (NRS satisfaction scale) [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)

3. Postoperative analgesic consumption [Over one week]

   Analgesic consumption over one week after the surgery

4. Postoperative functional level (QuickDASH questionnaire) [One week after surgery]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	American University of Beirut Medical Center	Beirut		Lebanon

Sponsors and Collaborators

• American University of Beirut Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Marie Awad, Professor of Anesthesiology, Interim Chairperson, American University of Beirut Medical Center
• ClinicalTrials.gov Identifier: NCT03732456
• Other Study ID Numbers: BIO-2018-0083
• First Posted: Nov 6, 2018
• Last Update Posted: Jun 12, 2020
• Last Verified: Jun 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Shoulder Pain; Pain, Postoperative

Study Results

No Results Posted as of Jun 12, 2020