E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
healthy volunteers ( intended for postoperative pain treatment in
patients after knee surgery) |
|
E.1.1.1 | Medical condition in easily understood language |
healthy volunteers ( intended for pain treatment in patients after knee
surgery) |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054711 |
E.1.2 | Term | Postoperative pain |
E.1.2 | System Organ Class | 100000004863 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate whether increased dose of local anesthetic (lidocain)
increases duration of peripheral nerve block (adductor canal block) |
|
E.2.2 | Secondary objectives of the trial |
To develop a model for assessing duration of peripheral nerve blockades |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age 18-30 years
Men
ASA 1
Body mass index 18-25 |
|
E.4 | Principal exclusion criteria |
Allergy to study medication
Earlier trauma or surgery to lower limb
Diabetes Mellitus |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Difference in duration of sensory block between different doses of
lidocain assessed with pinprick. |
|
E.5.1.1 | 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. |
|
E.5.2 | 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. |
|
E.5.2.1 | 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. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
different dosage of the same product |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |