Healthy volunteers (treatment intended for pain treatment in patients after hip surgery) MedDRA version: 19.0 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 100000004863
Conditions
Interventions
Trade Name: Ropivacain
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Perineural use
Sponsors
Department of Anesthesiology, Næstved Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age >18 ASA 1-2 BMI >18 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Allergy to study medication Alcohol consumption >21 units of alcohol per week Medical abuse (as judged by investigator) Daily intake of perscription painkillers within the last 4 weeks Intake of over the counter medication within 48 hours Earlier trauma, neuromusclare diseases, or surgery to lower limb Diabetes mellitus Cant cooperate Cant speak or understand danish Pregnant women
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Difference in the percentage coverage of the incision (anterolateral approach) between the side given ropivacain versus the side given saline assessed by cold sensation with an alcohol swab. -Difference in the percentage coverage of the incision (posterior approach) between the side given ropivacain versus the side given saline assessed by pinprick (von frey). -Difference in the percentage coverage of the incision (anterolateral approach) between the side given ropivacain versus the side given saline assessed by pinprick (von frey). -The percentage of patients with no sensory function (VAS = 0) assessed by Maximum pain during tonic heat stimulation test on the most superior part of the incision (posterior approach) on the side given ropivacain versus the side given saline. -The percentage of patients with no sensory function (VAS = 0) assessed by Maximum pain during tonic heat stimulation test on the most inferior part of the incision (posterior approach) on the side given ropivacain versus the side given saline. -The percentage of patients with no sensory function (VAS = 0) assessed by Maximum pain during tonic heat stimulation test on the most superior part of the incision (anterolateral approach) on the side given ropivacain versus the side given saline. -The percentage of patients with no sensory function (VAS = 0) assessed by Maximum pain during tonic heat stimulation test on the most inferior part of the incision (anterolateral approach) on the side given ropivacain versus the side given saline. -The percentage of patients with no sensory function (no pain detection) assessed by Heat pain detection threshold test on the most superior part of the incision (posterior approach) on the side given ropivacain versus the side given saline. -The percentage of patients with no sensory function (no pain detection) assessed by Heat pain detection threshold test on the most inferior part of the incision (posterior approach) on the side giv | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the sensory distribution of a LFCN-block;Secondary Objective: Not Applicable;Primary end point(s): -Difference in the percentage coverage of the incision (posterior approach) between the side given ropivacain versus the side given saline assessed by cold sensation with an alcohol swab.;Timepoint(s) of evaluation of this end point: 1 hour post block | — |
Countries
Denmark
Contacts
Public Contactoffice
Department of Anesthesiology, Næstved Hospital
Outcome results
None listed