ocal injection in the hip with an active pain reliever vs. an injection in the hip with a non active ingredient for patients who undergo a planned total hip surgery
- Conditions
- primary coxarthrosisTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
- Registration Number
- EUCTR2013-004031-71-NL
- Lead Sponsor
- Spaarne Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
-in writing given informed consent
-over 18 years of age
- operation indication: primary coxarthrosis
-Dutch speaking and understanding
-Spinal anaesthesia
-patients who go home after surgery (secondary outcome length of stay)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 160
-Patients who within 12 months prior to the surgery were opioid-dependent.
-malignancies.
-Patients with co-morbidities which may affect the possible pain perception (in the prehistory: CVA or a psychiatric disorder).
-Patients with allergies to ropivacaine
-ASA 3-4
-Patients with a peroperatieve complication occurs which interferes with the normal mobilization and pain experience (fractures, vascular/nerve injury
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method