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Intraoperative Arthroscopic Cold Irrigation Solution Improves Visual Clarity During Arthroscopic rotator cuff repair: A Double-Blind Randomized Controlled Trial

Intraoperative Arthroscopic Cold Irrigation Solution Improves Visual Clarity during Arthroscopic rotator cuff repair: A Double-Blind Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260102009
Enrollment
66
Registered
2026-01-02
Start date
2025-12-22
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator cuff injuries and Arthroscopic rotator cuff repair Rotator Cuff Arthroscopy Irrigation Cold Temperature Visual Clarity Randomized Controlled Trial

Interventions

Cold saline irrigation at 4 degrees C Epinephrine 1:1,000,000 added routinely to irrigation fluid ,Saline stored at ambient Operative room temperature (20 to 24 degrees C) Epinephrine 1:1,000,000 adde
Cold saline irrigation at 4 degree celcius,room temperature saline irrigation

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Adults aged 18 to 75 years 2.ASA physical status 1-3 3.Scheduled for elective shoulder arthroscopy for rotator cuff repair

Exclusion criteria

Exclusion criteria: 1.Known cold intolerance or Raynaud phenomenon 2.cold intolerance symptom severity (ciss) >50 3.Bleeding disorders or anticoagulant therapy 4.Prior arthroscopy on the same joint 5.Active infection or systemic inflammatory disease 6.Refusal or inability to provide informed consent

Design outcomes

Primary

MeasureTime frame
Visual clarity grading during arthroscopic surgery from start to end operation Visual clarity grading by using AI analysis video and image to clarify grading of visual clarity during perform surgery

Secondary

MeasureTime frame
operative time from start to end operation operative time,Postoperative pain 6 12 24 postop VAS,Analgesic consumption postop medical record,change of Core temperature every 5 minute during operation probe monitor core temperature,Intraarticular temperature every 15 minute during operation thermometer via RF,Joint swelling compare pre-postop measured by arm circumference 15 cm from lateral epicondyle along the acromion-lateral epicondyle line,complication intraopertative to discharge from hospital shivering,hypothermia,arryhtmia

Countries

Thailand

Contacts

Public ContactThanawat Tantimethanon

Faculty of medicine,Chulalongkorn Univeristy

tantimethanon.thanawat@gmail.com0818046998

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026