Healthy volunteers (treatment intended for pain treatment in patients after hip surgery) MedDRA version: 19.1 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 100000004863
Conditions
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 abuse (as judged by the investigator) 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 (from the hip to the knee) Diabetes mellitus Cant cooperate Cant speak or understand danish Woulds in the investigated area Pregnant women Large tattoos in the area of investigation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the sensory distribution of a LFCN-block with two different doses;Secondary Objective: Not applicable;Primary end point(s): -Difference in the percentage coverage of the incision (posterior approach) between the side given ropivacain, 16 ml, versus the side given ropivacain, 8 ml, assessed by cold sensation with an alcohol swab.;Timepoint(s) of evaluation of this end point: 1 hour post block | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Difference in the percentage coverage of the incision (anterolateral approach) between the side givenropivacain, 16 ml, versus the side given ropivacain, 8 ml, assessed by cold sensation with an alcohol swab. -Difference in the percentage coverage of the incision (posterior approach) between the side given ropivacain, 16 ml, versus the side given ropivacain, 8 ml, assessed by pinprick (von frey). -Difference in the percentage coverage of the incision (anterolateral approach) between the side given ropivacain, 16 ml, versus the side given ropivacain, 8 ml, 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, 16 ml, versus the side given ropivacain, 8 ml. -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 givenropivacain, 16 ml, versus the side given ropivacain, 8 ml. -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, 16 ml, versus the side given ropivacain, 8 ml. -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, 16 ml, versus the side given ropivacain, 8 ml. -Estimation of the areal of the sensory loss (including fotodocumentation) on the side given ropivacain, 16 ml, versus the side given ropivacain, 8 ml. Marked with the incicions -The difference in MVIC (maksimal voluntary isometric contraktion) of the knee joint between the side given ropivacain, 16 ml, versus t | — |
Countries
Denmark
Contacts
Public ContactOffice
Department of Anesthesiology, Næstved Hospital
Outcome results
None listed