Examination of Edema After Arthroscopic Shoulder Surgery

Edema Clinical Trial

Official title:

Examination of Edema After Arthroscopic Shoulder Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06014203
• Other study ID #: Iayas5
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: May 10, 2024

Study information

• Verified date: March 2024
• Source: Gazi University
• Contact: Inci H Ayas
• Phone: 05071740342
• Email: inciayass[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators's aim is to examine trunk and upper extremity edema after arthroscopic rotator cuff repair and/or labrum repair surgeries. During surgery, the shoulder joint capsule is cut and the joint is entered arthroscopically. During this procedure, approximately 3-6 liters of saline fluid is injected into the joint, depending on the duration of the surgery. The given fluid accumulates out of the joint in relation to the duration of the surgery and the amount of fluid given. In this study, the investigators aim is to examine how much the extra-articular fluid collects under the skin of the upper extremity and trunk, and the change in the amount of fluid 24 hours after surgery. Examination of the amount of subcutaneous fluid may help to better understand the postoperative complications such as edema, carpal tunnel syndrome, compartment syndrome, myolysis, and dyspnea. How much edema the joint and surrounding structures are exposed to and its relationship with the duration of surgery can help to clinicians determine the safe discharge time.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 10, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Arthroscopic shoulder surgery planned
• 18-65 years old

Exclusion Criteria:

• Frozen/stiff shoulder
• Metabolic and endocrine diseases
• Dermatological pathologies
• Hyperlaxity

Related Conditions & MeSH terms

• Arthroscopy
• Edema
• Shoulder

Intervention

Diagnostic Test:
• Edema measurement
Subcutaneous fluid measurements will be made 3 times in total, before the surgery, immediately after the surgery and 24 hours after the surgery. Measurements will be made with the MoistureMeterD Compact local edema measuring device. Points to be measured: Midpoint of the upper trapezius muscle 5 cm distal to anterior acromion 5cm distal to lateral acromion 5cm distal to posterior acromion 3cm medial to the axilla Anterior cubital fossa Carpal tunnel

Locations

Country	Name	City	State
Turkey	Gazi University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Edema	After the MoistureMeterD Compact local edema measuring device is placed perpendicular to the area to be measured, it will be held for 3 seconds and the percent moisture value will be recorded. 3 measurements will be made for each region. The average of the 3 measurements will be used in the statistical analysis.	3 months
Secondary	Surgery time	The duration of each operation will be recorded in minutes by the surgeon performing the operation.	3 months
Secondary	Amount of the saline	The amount of saline fluid used in each operation will be recorded in liters by the surgeon performing the operation.	3 months