A study in healthy volunteers investigating the effect of injecting local anesthetic on the front of the thigh under ultrasound-guidance in order to anesthetize the skin on the front and medial side of the knee

Phase 1

• Conditions: Pain around the surgical incisions after total knee arthroplasty (TKA).The area anesthetized by new nerve block techniques anesthetizing the medial femoral cutaneous nerve are investigated in healthy volunteers to see if the relevant area around the surgical incision sites are anesthetized.; MedDRA version: 21.1Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 100000004865; MedDRA version: 21.0Level: LLTClassification code 10002325Term: Anesthesia localSystem Organ Class: 100000004865; MedDRA version: 20.1Level: PTClassification code 10045434Term: Ultrasound scanSystem Organ Class: 10022891 - Investigations; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2020-004942-12-DK
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-13
• Last Update Posted: 17 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

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 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Unable to cooperate.
Unable to speak or understand Danish
Known neuropathy in the extremities
Infection in the areas around the injection sites
Obesity (Body Mass Index, BMI > 28 kg/m2)
Body weight < 60 kg
Pregnancy
Allergy towards any medical product used in the trial
Daily use of medicine except oral contraceptives

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified