does a regional hip anesthesia technique reduce pain after hip arthroplasty
- Conditions
- Our hypothesis is that a longitudinal approach to the fascia iliaca with a larger volume of local anesthetic will decrease morphine consumption and pain scores in patients after total hip arthroplasty compared to a control group.We will test our hypothesis in a double blind, randomized, placebo controlled trial.MedDRA version: 17.0Level: LLTClassification code 10044088Term: Total hip replacementSystem Organ Class: 100000004865Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2014-002122-12-BE
- Lead Sponsor
- az turnhout
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
After obtaining written, informed consent patients presenting for primary THA will be included in the study.
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 44
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 44
Exclusion Criteria
Exclusion criteria will be age <18years, BMI>35, intolerance to any of the drugs used in the study, opioid dependency and coagulopathy.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary endpoint of the study will be total morfine consumption during the first 24 hours. <br><br>;Secondary Objective: Secondary endpoints will be morphine consumption at 48 hours, pain scores, postoperative nausea and vomiting and number of blocked nerves using respons to pinprick in the sensory territories of the different nerves (femoral, obturator and lateral cutaneous).;Primary end point(s): The primary endpoint of the study will be total morfine consumption during the first 24 hours. ;Timepoint(s) of evaluation of this end point: Total Morphine consumption at 24 hours.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Secondary endpoints will be morphine consumption at 48 hours, pain scores, postoperative nausea and vomiting and number of blocked nerves using respons to pinprick in the sensory territories of the different nerves (femoral, obturator and lateral cutaneous).;Timepoint(s) of evaluation of this end point: Total Morphine consumption at 48 hours.