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 the automated cold compress innovation, including both the cold compress pad and the cooling device, and will undergo assessments of the effectiveness and safety of the innov
Device Feasibility
Healthy volunteers
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 |
|---|---|
| Safety of cold compress device use Throughout the 3-hour intervention period Assessment of adverse effects such as skin redness, numbness, abnormal pain, or cold injury, evaluated by clinical examination and symptom record form | — |
Secondary
| Measure | Time frame |
|---|---|
| Cold therapy related complications Within 3 hours after device initiation Occurrence of cold related complications such as skin injury, frostbite, or local tissue irritation recorded by the investigator | — |
Countries
Thailand
Contacts
Public ContactNuttakarn Koontorn
Thammasat University Hospital, Thammasat University
Outcome results
None listed