healthy volunteers (treatment intended for postoperative pain treatment in patients after knee surgery) MedDRA version: 16.0 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 100000004863
Conditions
Interventions
Trade Name: Ropivacaine
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ROPIVACAINE
CAS Number: 84057-95-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Sponsors
Professor Jørgen B. Dahl
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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 26 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 the lower limb Diabetes Mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether reducing the volume (30 versus 10 ml) ropivacaine injected can reduce the number of subjects with impaired muscle strength following adductor canal block;Secondary Objective: To investigate wheteher reducing the volume ropivacaine injected for adductor canal block has any effect on ambulation and reduces sensory effect of the block;Primary end point(s): The difference between the two volumes in number of subjects excperiencing a reduction in quadriceps muscle strength by more than 25% from baseline in two consecutive assessments. ;Timepoint(s) of evaluation of this end point: From 30 minutes to 6 hours post block | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): A: The difference between the two volumes in maximum voluntary isometric contraction (MVIC) of the quadriceps muscle, assessed as percentage of the baseline value. B: The difference between the two volumes in maximum voluntary isometric contraction (MVIC) of the quadriceps muscle calculated as ”area under the curve” (AUC) C: The difference between the pre block value and the post block value in the modified 30-second Chair Stand test on one leg, between the two volumes. D: The difference between the two volumes in VAS pain score during warmth stimulation ;Timepoint(s) of evaluation of this end point: A: 2, 3 and 4 hours post block B: Area under the curve for the interval 30 minutes to 6 hours post block C: Difference from pre block value at 2 and 4 hours post block D: Mean value for the periode 30 minutes - 6 hours post block | — |
Countries
Denmark
Contacts
Public ContactClinical Trials Information
Professor Jørgen B. Dahl
Outcome results
None listed