Postoperative pain and swelling following arthroscopic shoulder tendon repair, particularly rotator cuff repair, are conditions that can impair mobility, rehabilitation, and patients'
Conditions
Interventions
Participants will receive postoperative therapy using an automated hot and cold compression device designed to provide controlled thermal compression according to the study protocol. The device will b
s instructions. The effectiveness in reducing pain, swelling, and analgesic consumption will be evaluated and compared with the investigational device during the postoperative period.
Experimental Device,Active Comparator Device
Automated Hot and Cold Compression Device,Automated Cold Compression Device (Game Ready)
Sponsors
Thammasat University Hospital
Thammasat University
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Patients undergoing arthroscopic shoulder tendon repair at Thammasat University Hospital during both regular and after hours service periods 2. No history of cold sensitivity or allergic reactions to cold 3. No peripheral vascular diseases such as Buerger's disease 4. No diabetes mellitus with peripheral sensory neuropathy 5. No history of Raynaud's disease 6. No postoperative complications affecting consciousness or sensory function or requiring specific treatment such as shock or respiratory arrest 7. No history of morphine allergy or substance abuse 8. American Society of Anesthesiologists physical status class 1 to 3 9. Normal cognitive function vision hearing and communication ability 10. No psychiatric or neurological conditions affecting communication such as Alzheimer's disease or delirium 11. Patients receiving general anesthesia or regional anesthesia according to the treatment plan 12. Willingness to participate in the study and provide informed consent
Exclusion criteria
Exclusion criteria: 1. Patients who refuse to participate or withdraw their informed consent during the study 2. Patients with a history of cold sensitivity or allergic reactions to cold 3. Patients with peripheral vascular diseases such as Buerger's disease or Raynaud's disease 4. Patients with diabetes mellitus associated with peripheral sensory neuropathy 5. Patients with a history of morphine allergy or substance abuse 6. Patients who develop postoperative complications affecting consciousness or sensory function or requiring urgent medical treatment such as shock or respiratory arrest 7. Patients with communication difficulties, visual or hearing impairments, or psychiatric or neurological disorders that may affect study assessments 8. Patients who are unable to complete follow up during the 36 hour postoperative period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative pain intensity Baseline, 12, 24, and 36 hours after surgery Visual Analog Scale ,Shoulder swelling Baseline, 12, 24, and 36 hours after surgery Standardized shoulder circumference measurement | — |
Secondary
| Measure | Time frame |
|---|---|
| Analgesic consumption Within 36 hours after surgery Total postoperative analgesic dose recorded from medical records,Patient satisfaction At 36 hours after surgery or before hospital discharge Percentage of patients reporting satisfaction based on a structured satisfaction questionnaire | — |
Countries
Thailand
Contacts
Public ContactNuttakarn Koontorn
Thammasat University Hospital, Thammasat University
Outcome results
None listed