Treatment of postoperative pain after a total knee replacement MedDRA version: 14.1 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Ropivacain
Product Name: Ropivacain
Product Code: N01BB09
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Ropivacaine Hydrochloride
CAS Number: 98717-15-8
Other descripti
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age more or egual 30 years and less or egual 85 years Patients who have undergone a total knee replacement within 3 days (2.postoperative days included) and VAS scores> 60 in 45 degree active knæfleksion, despite conventional pain management. Patients who have given written informed consent to participate in the study after having understood this. ASA 1-3 BMI> 18 and =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Patients who can not cooperate with the investigation. • Patients who do not understand or speak Danish. • Allergy to those used in the study drugs. • Alcohol and / or drug abuse - the investigator's opinion. • Known sensory disturbances in the lower limbs. • Pregnancy Ensure that women of childbearing potential are not pregnant prior to study entry by carrying out a pregnancy test before enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We want to investigate the effect of Adducter-canal - blockade(AKB) vs. Femoral blockade(FB) on muscle strength, mobility and pain in patients with intense pain (VAS> 60) at the active 45-degree flexion of the knee joint 1-2. postoperative days after TKA, despite division standard pain. Our hypothesis is that AKB has fewer side effects in the form of reduced muscle strength and / or mobilization effort than FB, but has an analgesic effect that is not significantly different from FB ;Secondary Objective: Not applicable;Primary end point(s): The change in muscle strength, Maximum Voluntary Isometric Contraction (MVIC) of the quadriceps femoris muscle measured before and 2 hours after the blockade construction. The change compared between the two groups;Timepoint(s) of evaluation of this end point: Before and 2 hours after the blockade | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The change in muscle strength, MVIC, the adductor muscles measured before and 2 hours after the blockade construction. The change compared between the two groups. The change in the time it takes to complete a TUG-test, performed before and 2 hours after the blockade construction. The change compared between the two groups. The change in pain score, VAS, at rest, measured before and 2 hours after the blockade construction. The change compared between the two groups. The change in pain score, VAS, by passive 45 degree flexion of the knee joint measured before and 2 hours after the blockade construction. The change compared between the two groups. The change in the highest pain score VAS in TUG test measured before and 2 hours after blockade construction. The change compared between the two groups.;Timepoint(s) of evaluation of this end point: TUG test before and two hours after the Blockade. Painscore (VAS) when resting before and 2 hours after the blockade Painscore (VAS) when passive 45 degree flexion of the knee joint before and 2 hours after the blockade | — |
Countries
Denmark
Contacts
Public ContactDepartment of Anaestesia 4231, HOC
Rigshospitalet
Outcome results
None listed