- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02344264
Effect of Nervus Cutaneous Femoris Lateralis-Blockade on Moderate Pain Responders After Total Hip Arthroplasty
The patients will be included the 1. or 2. day after surgery. All THA patients will be screened. Those reporting VAS > 40 during active 30 degrees hip flexion will be asked to participate.
Included patients will receive 2xNCFL (singleshot) first placebo (8 ml saline) and then ropivacaine (8 ml ropivacaine 7,5mg/ml) or the other way around (randomized). There will be 45 minutes between the two blockades. The blockades will be ultrasound guided.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Danmark
-
Næstved, Danmark, Denmark, 4700
- Department of Anaesthesiology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- THA within 48 hours and VAS>40 during active 30 degrees hip flexion despite conventional pain medication.
- informed consent
- ASA 1-3
- BMI 18-40
Exclusion Criteria:
- Unable to communicate in danish
- Allergic reactions toward drugs used
- Abuse of alcohol/drugs
- Unable to cooperate
- Pregnant women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: RP
first blockade: ropivacaine 7,5mg/ml 8 ml second blockade: placebo: saline 8 ml
|
Arm RP is receiving 8 ml of ropivacaine 7,5 mg/ml at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with placebo (saline 8ml). Arm PR is receiving 8 ml of placebo (saline) at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with ropivacaine 8 ml.
Other Names:
Arm RP is receiving 8 ml of ropivacaine 7,5 mg/ml at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with placebo (saline 8ml). Arm PR is receiving 8 ml of placebo (saline) at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with ropivacaine 8 ml.
Other Names:
|
Other: PR
first blockade: placebo: saline 8 ml second blockade: ropivacaine 7,5mg/ml 8 ml
|
Arm RP is receiving 8 ml of ropivacaine 7,5 mg/ml at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with placebo (saline 8ml). Arm PR is receiving 8 ml of placebo (saline) at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with ropivacaine 8 ml.
Other Names:
Arm RP is receiving 8 ml of ropivacaine 7,5 mg/ml at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with placebo (saline 8ml). Arm PR is receiving 8 ml of placebo (saline) at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with ropivacaine 8 ml.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Difference in VAS between NCFL and placebo during active 30 degrees hip flexion
Time Frame: 45 min
|
45 min
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Difference in mean VAS between the groups during active hip flexion
Time Frame: 15, 30, 45, 60, 75, 90 min
|
15, 30, 45, 60, 75, 90 min
|
Difference in mean VAS between the groups at rest
Time Frame: 15, 30, 45, 60, 75, 90 min
|
15, 30, 45, 60, 75, 90 min
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Daniel Hägi-Pedersen, Ph.D., Naestved Hospital, Department of Anaesthesiology
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PROTOKOL - 001-2014 - KHTY
- 2014-003730-10 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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