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

Sponsor
Daniel Hägi-Pedersen (Other)
Overall Status
Completed
CT.gov ID
NCT02344264
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
8
Duration (Months)
7.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Nervus Cutaneous Femoris Lateralis-Blockade on Moderate Pain Responders After Total Hip Arthroplasty
Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Sep 1, 2015
Actual Study Completion Date :
Sep 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Other: RP

first blockade: ropivacaine 7,5mg/ml 8 ml second blockade: placebo: saline 8 ml

Drug: Ropivacaine
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:
  • Naropin

    • Drug: Saline
    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:
  • NaCl
  • Placebo

    		•
    Other: PR

    first blockade: placebo: saline 8 ml second blockade: ropivacaine 7,5mg/ml 8 ml

    Drug: Ropivacaine
    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:
  • Naropin

    • Drug: Saline
    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:
  • NaCl
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Difference in VAS between NCFL and placebo during active 30 degrees hip flexion [45 min]

    Secondary Outcome Measures

    1. Difference in mean VAS between the groups during active hip flexion [15, 30, 45, 60, 75, 90 min]

    2. Difference in mean VAS between the groups at rest [15, 30, 45, 60, 75, 90 min]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anaesthesiology Næstved Danmark Denmark 4700

    Sponsors and Collaborators

    • Daniel Hägi-Pedersen

    Investigators

    • Study Chair: Daniel Hägi-Pedersen, Ph.D., Naestved Hospital, Department of Anaesthesiology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daniel Hägi-Pedersen, Consultant, Naestved Hospital
    ClinicalTrials.gov Identifier:
    NCT02344264
    Other Study ID Numbers:
    • PROTOKOL - 001-2014 - KHTY
    • 2014-003730-10
    First Posted:
    Jan 22, 2015
    Last Update Posted:
    Sep 25, 2015
    Last Verified:
    Sep 1, 2015
    Keywords provided by Daniel Hägi-Pedersen, Consultant, Naestved Hospital
    US guided nerve block
    Total hip Arthroplasty
    NCFL
    nervus cutaneous femoralis lateralis
    Additional relevant MeSH terms:
    Pain, Postoperative
    Ropivacaine

    Study Results

    No Results Posted as of Sep 25, 2015