Effect of Nervus Cutaneous Femoris Lateralis-Blockade on Moderate Pain Responders After Total Hip Arthroplasty

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Nervus Cutaneous Femoris Lateralis-Blockade on Moderate Pain Responders After Total Hip Arthroplasty

Conditions
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Pain, Postoperative, Ropivacaine, Therapeutic Use, Arthroplasty, Replacement, Hip

Intervention / Treatment
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* Drug: Ropivacaine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: RP<br>first blockade: ropivacaine 7,5mg/ml 8 ml second blockade: placebo: saline 8 ml | Drug: Ropivacaine<br>* 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.<br>* Other names: Naropin;Drug: Saline<br>* 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.<br>* Other names: Placebo;|
| Other: PR<br>first blockade: placebo: saline 8 ml second blockade: ropivacaine 7,5mg/ml 8 ml | Drug: Ropivacaine<br>* 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.<br>* Other names: Naropin;Drug: Saline<br>* 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.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in VAS between NCFL and placebo during active 30 degrees hip flexion |  | 45 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in mean VAS between the groups during active hip flexion |  | 15, 30, 45, 60, 75, 90 min | 
| Difference in mean VAS between the groups at rest |  | 15, 30, 45, 60, 75, 90 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NCFL, US guided nerve block, Total hip Arthroplasty, nervus cutaneous femoralis lateralis