EUCTR2017-005180-40-DK
Active, not recruiting
Phase 1
The effect of the popliteal plexus block on postoperative pain after total knee arthroplasty - a randomized, controlled, double-blinded study
Aarhus University Hospital0 sites70 target enrollmentJanuary 8, 2018
ConditionsPostoperative posterior pain after total knee arthroplastyMedDRA version: 20.0Level: PTClassification code 10023469Term: Knee arthroplastySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: LLTClassification code 10002325Term: Anesthesia localSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Postoperative posterior pain after total knee arthroplasty
- Sponsor
- Aarhus University Hospital
- Enrollment
- 70
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Male or female at least 50 years of age at screening
- •\- Scheduled to undergo primary total knee arthroplasty in spinal anaesthesia
- •\- Normal sensory function at the lateral part of the thigh and lower leg
- •\- American Society of Anesthesiologists (ASA) physical status 1, 2, or 3
- •\- Able to provide informed consent
- •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 10
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •\- Unable to cooperate and follow the study protocol
- •\- Communication problems
- •\- Allergic towards any medical product administered in the study
- •\- Diabetes requiring medical treatment
- •\- Pregnancy (a pregnancy test will be conducted on all women of childbearing potential prior to inclusion in the study. A positive test result will result in exclusion from the study)
- •\- Preoperative opioid treatment (dosed \> once daily)
Outcomes
Primary Outcomes
Not specified
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