EUCTR2021-002765-17-CZ
Active, not recruiting
Phase 1
Risk-benefit analysis of intrathecal morphine administration to patients undergoing surgical treatment of proximal femoral fracture (monocentric, single-blinded, randomised clinical study compared to standard treatment)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Fakultní nemocnice Ostrava
- Enrollment
- 50
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. signed informed consent
- •2\. male and female
- •3\. 60 to 90 years of age
- •4\. surgical treatment of proximal femure fracture
- •5\. ASA classification I to III
- •6\. spinal anaesthesia used for the operation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 50
Exclusion Criteria
- •1\. general anaesthesia used for the operation
- •2\. allergy for the opioids
- •3\. high risk of respiratory depression
Outcomes
Primary Outcomes
Not specified
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