The effect of different doses of local anesthetic on duration of a nerveblockade.
- Conditions
- healthy volunteers ( intended for postoperative pain treatment inpatients after knee surgery)MedDRA version: 16.1Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 100000004863Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2014-001752-31-DK
- Lead Sponsor
- Professor Jørgen B. Dahl
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
Age 18-30 years
Men
ASA 1
Body mass index 18-25
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 14
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Allergy to study medication
Earlier trauma or surgery to lower limb
Diabetes Mellitus
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate whether increased dose of local anesthetic (lidocain)<br>increases duration of peripheral nerve block (adductor canal block);Secondary Objective: To develop a model for assessing duration of peripheral nerve blockades;Primary end point(s): Difference in duration of sensory block between different doses of<br>lidocain assessed with pinprick.;Timepoint(s) of evaluation of this end point: Duration is defined as the time from block performance until recovery of sensation to pin-prick stimulus, assessed at 30 and 60 minutes post<br>block, and thereafter every hour.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Difference in duration of sensory block between different doses of<br>lidocain assessed with:<br>- heat pain detection threshold<br>- warmth detection threshold<br>- pain during 1 minute of warmth stimulation<br>- tolerance to transcutane electrical stimulation<br>- cold sensation<br>Difference in duration of motor block between different doses of lidocain<br>assessed as maximum voluntary isometric contraction.<br>Difference in onset of sensory blockade between different doses of<br>lidocain, assessed with pinprick.;Timepoint(s) of evaluation of this end point: Duration is defined as time from block performance until recovery of<br>normal sensation/ muscle strength, assessed at 30 and 60 minutes post<br>block, and thereafter every hour.<br>Onset is defined as the time from block performance until loss of<br>sensation to pin-prick stimulus assessed at 30 and 60 minutes post<br>block, and thereafter every hour.