A comparison of two nerve blockade - adductor Channel Blockade vs. Femoral Blockade - on muscle strength, mobility and pain in patients with severe pain first or 2 days after insertion of artificial knees
- Conditions
- Treatment of postoperative pain after a total knee replacementMedDRA version: 14.1Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 100000004865Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2012-004554-28-DK
- Lead Sponsor
- Rigshospitalet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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 <40
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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br><br>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<br>;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 Outcome Measures
Name Time Method