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Clinical Trials/EUCTR2021-002765-17-CZ
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)

Fakultní nemocnice Ostrava0 sites50 target enrollmentMay 28, 2021

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.

Registry
who.int
Start Date
May 28, 2021
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

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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