healthy volunteers ( intended for postoperative pain treatment in patients after knee surgery) MedDRA version: 16.1 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 100000004863
Conditions
Interventions
Trade Name: Lidocain
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Lidocaine 5 mg/ml
Other descriptive name: LIDOCAINE
Concentration unit: mg/ml milligram(s)/millilitre
Concentratio
Sponsors
Professor Jørgen B. Dahl
Eligibility
Sex/Gender
Male
Inclusion criteria
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
Exclusion criteria: Allergy to study medication Earlier trauma or surgery to lower limb Diabetes Mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether increased dose of local anesthetic (lidocain) 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 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 block, and thereafter every hour. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Difference in duration of sensory block between different doses of lidocain assessed with: - heat pain detection threshold - warmth detection threshold - pain during 1 minute of warmth stimulation - tolerance to transcutane electrical stimulation - cold sensation Difference in duration of motor block between different doses of lidocain assessed as maximum voluntary isometric contraction. Difference in onset of sensory blockade between different doses of lidocain, assessed with pinprick.;Timepoint(s) of evaluation of this end point: Duration is defined as time from block performance until recovery of normal sensation/ muscle strength, assessed at 30 and 60 minutes post block, and thereafter every hour. Onset is defined as the time from block performance until loss of sensation to pin-prick stimulus assessed at 30 and 60 minutes post block, and thereafter every hour. | — |
Countries
Denmark
Contacts
Public ContactClinical Trials Information
Professor Jørgen B. Dahl
Outcome results
None listed