EUCTR2018-004986-15-DK
Active, not recruiting
Phase 1
ltrasound-guided nerve block of the anterior femoral cutaneous nerves in healthy volunteers
Aarhus University Hospital0 sites40 target enrollmentJanuary 3, 2019
ConditionsPain around the surgical incision after total knee arthroplasty (TKA). The area anesthetized by a combination of nerve block techniques anesthetizing the anterior femoral cutaneous nerves are investigated in healthy volunteers to see if the relevant area around the surgical incision site is anesthetized.MedDRA version: 20.0Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 100000004865MedDRA version: 20.0Level: LLTClassification code 10002325Term: Anesthesia localSystem Organ Class: 100000004865MedDRA version: 20.1Level: PTClassification code 10045434Term: Ultrasound scanSystem Organ Class: 10022891 - InvestigationsTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
DrugsRopivacain
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Pain around the surgical incision after total knee arthroplasty (TKA). The area anesthetized by a combination of nerve block techniques anesthetizing the anterior femoral cutaneous nerves are investigated in healthy volunteers to see if the relevant area around the surgical incision site is anesthetized.
- Sponsor
- Aarhus University Hospital
- Enrollment
- 40
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \= 18 years
- •American Society of Anesthesiologists physical status classification score (ASA) I\-II
- •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 40
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range 0
Exclusion Criteria
- •Unable to cooperate
- •Unable to speak or understand Danish
- •Known neuropathy in the extremities
- •Chronic, opioid\-requiring pain
- •Infection in the areas around the injection sites
- •Obesity (Body Mass Index, BMI \> 28 kg/m2\)
- •Body weight \< 60 kg
- •Allergy towards any medical product used in the trial
Outcomes
Primary Outcomes
Not specified
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