The Impact of Biological Gender in Peripheral Nerve Blockade: A Prospective Study in Volunteers

Phase 4

• Conditions: Gender differences in regional anaesthesia

• Registration Number: DRKS00030404
• Lead Sponsor: Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-04
• Study Completion: 2023-02-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Healthy males and females
-Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination as determined by the Investigator/Sub-Investigator
-Signed written informed consent prior to inclusion in the study
-18-55 years old inclusive
-BMI: 18 to 35 kg/m2
-Ability to understand the full nature and purpose of the study, including possible risks and side effects
-Ability to co-operate with the investigator and to comply with the requirements of the entire study
-Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements

Exclusion Criteria

-Any clinically relevant abnormalities at ECG (12 leads)
-Any clinically relevant abnormal physical findings
-Any clinically relevant abnormal laboratory values indicative of physical illness
-Ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients of the study drug
-History of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study
-Pregnancy (female volunteers)
-Relevant history of malignancy, of renal, hepatic, cardiovascular, respiratory, gastrointestinal, musculoskeletal, skin (particularly at the site of drug application), haematological, endocrine or neurological diseases that may interfere with the aim of the study
-Any psychiatric illnesses
-Using other medications during 1 week before the start of IMP application including OTC
-Participation in another clinical study investigating another IMP within 1 month prior to screening
-Blood donations during 4 weeks prior to this study
-History of drug or alcohol abuse (>2 drinks/day, defined according to USDA Dietary Guidelines 2015)
-Other objections to study participation in the opinion of the investigator

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is duration of sensory block following a ultrasound guided block of the ulnar nerve with ropivacaine 0,75%

Secondary Outcome Measures

Name	Time	Method
- Pharmacokinetic properties (Cmax, tmax, t1/2, AUC0-6, AUC0-8)<br> - Maximum concentration (Cmax)<br> - Time to maximum concentration (tmax)<br> - Terminal elimination half-life (t1/2)<br> - Area under the concentration-time curve (AUC) for the sampling period of 6 h (AUC0-6)<br><br>- Duration of the motor blockade<br>- Onset of sensory nerve block<br>- Onset of motor blockade<br>- Diameter of the N. ulnaris (absolute and relative to BMI)<br>- Visibility of the ulnar nerve in ultrasound (gray tone analysis of the ulnar nerve relative to the surrounding tissue)