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Continuous Lumbar Plexus Block for Postoperative Pain Control After Total Hip Arthroplasty

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
continuous infusion of ropivacaine via CLPB vs. CFB vs IV PCA
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Continuous lumbar plexus,Femoral,hydromorphone

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18-80 years old
  • primary diagnosis of osteoarthritis

Exclusion Criteria:

  • allergy to local anesthetics
  • peripheral neuropathy
  • opioid dependency
  • dementia
  • coagulopathy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    PCA;active comparator

    CFB

    CLPB

    Arm Description

    Patients with intravenous PCA hydromorphone alone

    Patients with a continuous femoral block (CFB) + PCA hydromorphone

    Patients with a continuous lumbar plexus block + PCA hydromorphone

    Outcomes

    Primary Outcome Measures

    VAS pain scores

    Secondary Outcome Measures

    hydromorphone consumption,patient satisfaction,distance ambulated, opioid-related side effects

    Full Information

    First Posted
    November 12, 2008
    Last Updated
    November 12, 2008
    Sponsor
    Northwell Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00790179
    Brief Title
    Continuous Lumbar Plexus Block for Postoperative Pain Control After Total Hip Arthroplasty
    Official Title
    Continuous Lumbar Plexus Block for Postoperative Pain Control After Total Hip Arthroplasty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2003 (undefined)
    Primary Completion Date
    January 2007 (Actual)
    Study Completion Date
    March 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Northwell Health

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Continuous lumbar plexus and femoral blocks have been demonstrated to provide effective postoperative analgesia of the lower extremity following total joint arthroplasty. The purpose of this study was to compare these two techniques when used with intravenous patient-controlled analgesia and the use of patient-controlled analgesia alone for postoperative pain management following unilateral total hip arthroplasty.
    Detailed Description
    above may be applied

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain
    Keywords
    Continuous lumbar plexus,Femoral,hydromorphone

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    225 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PCA;active comparator
    Arm Type
    Active Comparator
    Arm Description
    Patients with intravenous PCA hydromorphone alone
    Arm Title
    CFB
    Arm Type
    Active Comparator
    Arm Description
    Patients with a continuous femoral block (CFB) + PCA hydromorphone
    Arm Title
    CLPB
    Arm Type
    Active Comparator
    Arm Description
    Patients with a continuous lumbar plexus block + PCA hydromorphone
    Intervention Type
    Procedure
    Intervention Name(s)
    continuous infusion of ropivacaine via CLPB vs. CFB vs IV PCA
    Intervention Description
    0.5% Ropivacaine bolus of 30 ml. followed by ropivacaine 0.2%at 10 ml/hr via CLPB vs. CFB. Hydromorphone 0.3 mg demand only every 10 minutes via IV PCA.
    Primary Outcome Measure Information:
    Title
    VAS pain scores
    Time Frame
    at 24 and 48 hours
    Secondary Outcome Measure Information:
    Title
    hydromorphone consumption,patient satisfaction,distance ambulated, opioid-related side effects
    Time Frame
    at 24 and 48 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 18-80 years old primary diagnosis of osteoarthritis Exclusion Criteria: allergy to local anesthetics peripheral neuropathy opioid dependency dementia coagulopathy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Joseph Marino, M.D.
    Organizational Affiliation
    Huntington Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Continuous Lumbar Plexus Block for Postoperative Pain Control After Total Hip Arthroplasty

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