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 of the thigh and knee

Phase 1

• 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.; MedDRA version: 20.0Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 100000004865; MedDRA version: 20.0Level: 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: EUCTR2018-004986-15-DK
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-03
• Study Completion: 2019-04-07
• Last Update Posted: 11 May 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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
Pregnancy
Allergy towards any medical product used in the trial

Study & Design

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