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Clinical Trials/EUCTR2017-002170-39-FI
EUCTR2017-002170-39-FIActive, not recruitingPhase 1

Combination of intrathecal morphine and local infiltration analgesia in treatment postoperative pain of total knee arthroplasty

Eksote0 sites120 target enrollmentStarted: August 16, 2017Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
120

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Inclusion Criteria

  • - 120 patients who have given their written consent
  • - primary total knee arthroplasty
  • - age 18-85 years
  • - ASA I-III
  • - suitable for spinal anesthesia
  • - NSAID not contraindicated
  • 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 40
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

  • - age <18 or >86 yrs
  • - weight < 50 kgs or BMI =35 kg/m2
  • - ASA IV - V
  • - reoperation
  • - preoperative SpO2 <93%
  • - dementia
  • - drug or alcohol abuse
  • - preoperative use of strong opioids, gabapentin or pregabalin
  • - any drug of the research protocol is contraindicated

Investigators

Sponsor
Eksote

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