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Effect of a Lateral Nerve of the Thigh Block on Postoperative Pain After Total Hip Replacement Surgery

Primary Purpose

Pain, Postoperative, Anesthesia, Conduction, Arthroplasty, Replacement, Hip

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ropivacaine
Placebo
An ultrasound-guided Nervus cutaneous femoral lateralis blockade will be given postoperatively
Sponsored by
Daniel Hägi-Pedersen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Postoperative pain, regional anaesthesia, total hip replacement, nervus cutaneous femoral lateralis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary total hip replacement

Exclusion Criteria:

  • general anaesthesia
  • Allergy to local anesthetics of the amide type
  • Revision surgery
  • Bilateral surgery
  • Chronic pain patient
  • Women in the fertile age

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Ropivacaine

    Placebo

    Arm Description

    8 ml of ropivacaine 7,5 mg/ml will be injected around nervus cutaneous femoral lateralis. Ultrasound-guided.

    8 ml of isotonic saline will be injected around nervus cutaneous femoral lateralis. Ultrasound-guided

    Outcomes

    Primary Outcome Measures

    VAS-score 4 hours postoperative during movement
    VAS-score 4 hours postoperative during 30 degrees of flexion of the hip. VAS-score: 0-100 mm; 0: no pain, 100: worst imaginable pain.

    Secondary Outcome Measures

    VAS-score 0-24 hours postoperative during movement
    VAS-score 0, 1, 2, 8, 12, and 24 hours postoperative during 30 degrees of flexion of the hip. VAS-score: 0-100 mm; 0: no pain, 100: worst imaginable pain.
    VAS-score 0-24 hours postoperative at rest
    VAS-score 0, 1, 2, 4, 8, 12, and 24 hours postoperative at rest. VAS-score: 0-100 mm; 0: no pain, 100: worst imaginable pain.
    Oxynorm consumption
    Oxynorm consumption 24 hours postoperative
    time to first oxynorm requirement
    Mobilization
    time to first mobilization
    Mobilization
    Ability to mobilize judged by the cumulated ambulation (CAS) score: 0-6; 0 no mobilization, 6: fully mobilized
    Length of stay

    Full Information

    First Posted
    November 10, 2014
    Last Updated
    November 12, 2014
    Sponsor
    Daniel Hägi-Pedersen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02289937
    Brief Title
    Effect of a Lateral Nerve of the Thigh Block on Postoperative Pain After Total Hip Replacement Surgery
    Official Title
    Effect of a Lateral Nerve of the Thigh Block on Postoperative Pain After Total Hip Replacement Surgery: a Clinical Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2014 (undefined)
    Primary Completion Date
    October 2014 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Daniel Hägi-Pedersen

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study was to evaluate the analgesic efficacy of the nervus cutaneous femoral lateralis (NCFL) blockade on postoperative pain after total hip replacement surgery. The NCFL-block is a pure sensory block. We hypothesized that the NCFL-block would reduced the postoperative pain without delaying mobilization.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Postoperative, Anesthesia, Conduction, Arthroplasty, Replacement, Hip
    Keywords
    Postoperative pain, regional anaesthesia, total hip replacement, nervus cutaneous femoral lateralis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ropivacaine
    Arm Type
    Experimental
    Arm Description
    8 ml of ropivacaine 7,5 mg/ml will be injected around nervus cutaneous femoral lateralis. Ultrasound-guided.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    8 ml of isotonic saline will be injected around nervus cutaneous femoral lateralis. Ultrasound-guided
    Intervention Type
    Drug
    Intervention Name(s)
    Ropivacaine
    Other Intervention Name(s)
    Naropin
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Saline, NaCl
    Intervention Type
    Device
    Intervention Name(s)
    An ultrasound-guided Nervus cutaneous femoral lateralis blockade will be given postoperatively
    Primary Outcome Measure Information:
    Title
    VAS-score 4 hours postoperative during movement
    Description
    VAS-score 4 hours postoperative during 30 degrees of flexion of the hip. VAS-score: 0-100 mm; 0: no pain, 100: worst imaginable pain.
    Time Frame
    4 hours postoperative
    Secondary Outcome Measure Information:
    Title
    VAS-score 0-24 hours postoperative during movement
    Description
    VAS-score 0, 1, 2, 8, 12, and 24 hours postoperative during 30 degrees of flexion of the hip. VAS-score: 0-100 mm; 0: no pain, 100: worst imaginable pain.
    Time Frame
    0-24 hours postoperatively
    Title
    VAS-score 0-24 hours postoperative at rest
    Description
    VAS-score 0, 1, 2, 4, 8, 12, and 24 hours postoperative at rest. VAS-score: 0-100 mm; 0: no pain, 100: worst imaginable pain.
    Time Frame
    0-24 hours postoperatively
    Title
    Oxynorm consumption
    Description
    Oxynorm consumption 24 hours postoperative
    Time Frame
    0-24 hours postoperative
    Title
    time to first oxynorm requirement
    Time Frame
    0-24 hours postoperatively
    Title
    Mobilization
    Description
    time to first mobilization
    Time Frame
    0-24 hours postoperatively
    Title
    Mobilization
    Description
    Ability to mobilize judged by the cumulated ambulation (CAS) score: 0-6; 0 no mobilization, 6: fully mobilized
    Time Frame
    0-24 hours postoperatively
    Title
    Length of stay
    Time Frame
    0-7 days postoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Primary total hip replacement Exclusion Criteria: general anaesthesia Allergy to local anesthetics of the amide type Revision surgery Bilateral surgery Chronic pain patient Women in the fertile age
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Daniel Hägi-Pedersen, M.D., Ph.D.
    Organizational Affiliation
    Naestved Hospital, Department of Anaesthesiology
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of a Lateral Nerve of the Thigh Block on Postoperative Pain After Total Hip Replacement Surgery

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