The Effect of Local Anesthetic Volume within the Adductor Canal on Quadriceps Function Evaluated by Electromyography:A Randomized, Observer-Masked, Placebo-Controlled Study in Volunteers.

Phase 1

• Conditions: Healthy volunteers. Results will be used for optimizing the treatment of post-operative pain after total knee arthroplasty; MedDRA version: 17.1Level: SOCClassification code 10022891Term: InvestigationsSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2014-004601-32-DK
• Lead Sponsor: Gentofte Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-29
• Last Update Posted: 16 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

•Age > 18 years old
•Subjects who gave their written informed consent to participating in the study after having fully understood the contents of the protocol and re-strictions.
•ASA 1
•Male
•BMI 18–30
•Physical exercise 1-3 hours/week

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

•Subjects who cannot cooperate with the study.
•Subjects who cannot understand or speak Danish.
•Subjects with allergy to the medicines used in the study.
•Subjects suffering from alcohol and/or drug abuse – based on the inves-tigator's opinion.
•Pathology or previous surgery or trauma to the lower limb.
•Intense exercise 24 h before the tests
•Intake of any analgesics 24 h prior to baseline measurements.

Study & Design

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