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The effect of tranexamic acid in combination with dexamethasone on the quality of recovery after arthroscopic rotator cuff repair of the shoulder: a prospective, randomised, controlled trial

The effect of tranexamic acid in combination with dexamethasone on the quality of recovery after arthroscopic rotator cuff repair of the shoulder: a prospective, randomised, controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078507
Enrollment
Unknown
Registered
2023-12-11
Start date
2023-12-11
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

Rotator cuff tear

Interventions

A:100ml saline and 100ml saline
B:100ml (1g tranexamic acid) and 100ml saline
C:100ml (1g tranexamic acid) and (0.5mg/ml dexamethasone)

Sponsors

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: Age 40-80 years old; BMI<35kg/m^2; ASA class I or II; Diagnosed with rotator cuff tear based on the clinical manifestation, physical examination, imaging manifestation, and confirmed diagnosis as rotator cuff tear during the surgery; only one shoulder for surgery not both.

Exclusion criteria

Exclusion criteria: Lung disease (lung infection, emphysema, COPD et al.); Renal injuries (BUN and/or Cr>upper limit of normal value); Liver disease (ALT and/or AST > 1.5 times the upper limit of normal value); Coagulation function defect (PT/APTT above the upper limit of normal value); Using anti-coagulation or anti-platelet drugs recently or in a long period; Hb or Hct concentration is abnormal before surgery; The history of heart disease or other chronic diseases; Psychological or neurological disease, or cannot properly express their opinions; Taking sedative, analgesic, and psychotropic drugs in a long period of time; Excessive drinking or taking drugs; Taking corticosteroids two weeks before surgery; Epidural or articular injection of corticosteroids three months before surgery; Taking opioids daily two weeks before surgery; High blood glucose level; Pregonant; Obesity (BMI>35 kg/m^2); Allergy to tranexamic acid or dexamethasone; Other contraindication for using tranexamic acid or dexamethasone.

Design outcomes

Primary

MeasureTime frame
QoR-15 value at 24 hours after surgery;

Secondary

MeasureTime frame
QoR-15 value before surgery;Resting VAS value at 0-4h,5-8h,9-12h,13-16h,17-20h,21-24h after surgery;The starting time of shoulder pain after surgery;The values of blood glucose, CRP, IL-6, IL-1, IL-10, and TNF before surgery and at 24 hours after surgery;The values of Hb, PT, APTT, INR, fibrinogen, and platelet before surgery and at 24 hours after surgery;The range of motion , ASES value, Constant value before surgery and at 3 months after surgery;The occur of other complications;

Countries

China

Contacts

Public ContactYu, Weilin

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

yuweilin2008@163.com+86 159 0174 1070

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026