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Study of Nerve Block Anesthesia for Surgery of Hip Fracture in the Elderly

Primary Purpose

Anesthesia; Reaction

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
paravertebral nerve
lumbar and sacral plexus block
Sponsored by
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia; Reaction

Eligibility Criteria

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

Inclusion Criteria:

  • ASA Ⅰ-Ⅲ
  • hip fracture need surgery

Exclusion Criteria:

  • patient refusal
  • chronic use of opioids
  • coagulation disorders
  • preexisting neurological disorders

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    paravertebral nerve

    lumbar and sacral plexus block

    Arm Description

    Injection with 20ml 0.5% ropivacaine at lumbar plexus(level L3-4) , 10ml 0.5%ropivacaine at sacral plexus and 10ml 0.5%ropivacaine at paravertebral nerve(level L1)

    a lumbar and sacral plexus block(LS) group with 20ml 0.5% ropivacaine at lumbar plexus(level L3-4) and 10ml 0.5%ropivacaine at sacral plexus;

    Outcomes

    Primary Outcome Measures

    cumulative propofol dose

    Secondary Outcome Measures

    The optimal target concentration propofol

    Full Information

    First Posted
    March 3, 2014
    Last Updated
    December 30, 2014
    Sponsor
    Shanghai Jiao Tong University Affiliated Sixth People's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02104908
    Brief Title
    Study of Nerve Block Anesthesia for Surgery of Hip Fracture in the Elderly
    Official Title
    Target-controlled Propofol Infusion as a Technique of Anesthesia for Surgery of Hip Fracture Under Ultrasound Guidance Lumbar and Sacral Plexus Block or Lumbar, Sacral and Paravertebral Nerve Block in the Elderly
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2014 (undefined)
    Primary Completion Date
    December 2014 (Anticipated)
    Study Completion Date
    December 2014 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai Jiao Tong University Affiliated Sixth People's Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The investigators aim to examine target-controlled propofol infusion as a technique of anesthesia for surgery of hip fracture under ultrasound guidance lumbar and sacral plexus block or lumbar, sacral and paravertebral nerve block in the elderly; and to evaluate which regional anesthesia was more sufficient for the old.
    Detailed Description
    Eighty patients with American Society of Anesthesiologists(ASA) Ⅰ-Ⅲ older than 80 years are randomly assigned to 2 groups: a lumbar and sacral plexus block(LS) group with 20ml 0.5% ropivacaine at lumbar plexus(level L3-4) and 10ml 0.5%ropivacaine at sacral plexus; a lumbar, sacral plexus and paravertebral nerve block(LSP) group with 20ml 0.5% ropivacaine at lumbar plexus(level L3-4) , 10ml 0.5%ropivacaine at sacral plexus and 10ml 0.5%ropivacaine at paravertebral nerve(level L1). The target-controlled propofol infusion is started immediately after positioning the patient on the operating table. The initial target concentration was 0.5μg/mL. The infusion rate is adjusted every 5min by increasing or decreasing the target concentration by 0.2μg/mL steps based on the patients' respiratory rate(RR), blood pressure(BP), heart rate(HR), and level of sedation(score of 5 on Ramsay Sedation Scale ). The minimal, maximal, optimal target concentration, cumulative propofol dose, frequency of spontaneous movement and incidences of associated complications are recorded. Patients were phoned for followup and questioned for activity status in one year. If the patients were dead, date of death; if they survived, daily living activity questioned.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anesthesia; Reaction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    paravertebral nerve
    Arm Type
    Experimental
    Arm Description
    Injection with 20ml 0.5% ropivacaine at lumbar plexus(level L3-4) , 10ml 0.5%ropivacaine at sacral plexus and 10ml 0.5%ropivacaine at paravertebral nerve(level L1)
    Arm Title
    lumbar and sacral plexus block
    Arm Type
    Other
    Arm Description
    a lumbar and sacral plexus block(LS) group with 20ml 0.5% ropivacaine at lumbar plexus(level L3-4) and 10ml 0.5%ropivacaine at sacral plexus;
    Intervention Type
    Procedure
    Intervention Name(s)
    paravertebral nerve
    Intervention Description
    a lumbar, sacral plexus and paravertebral nerve block(LSP) group with 20ml 0.5% ropivacaine at lumbar plexus(level L3-4) , 10ml 0.5%ropivacaine at sacral plexus and 10ml 0.5%ropivacaine at paravertebral nerve(level L1).
    Intervention Type
    Procedure
    Intervention Name(s)
    lumbar and sacral plexus block
    Intervention Description
    a lumbar and sacral plexus block(LS) group with 20ml 0.5% ropivacaine at lumbar plexus(level L3-4) and 10ml 0.5%ropivacaine at sacral plexus;
    Primary Outcome Measure Information:
    Title
    cumulative propofol dose
    Time Frame
    24 weeks
    Secondary Outcome Measure Information:
    Title
    The optimal target concentration propofol
    Time Frame
    24 weeks
    Other Pre-specified Outcome Measures:
    Title
    Mortality
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ASA Ⅰ-Ⅲ hip fracture need surgery Exclusion Criteria: patient refusal chronic use of opioids coagulation disorders preexisting neurological disorders
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Daqiang Zhao, Master
    Organizational Affiliation
    Shanghai Jiaotong University Affiliated Sixth People's Hospital Shanghai,China
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Study of Nerve Block Anesthesia for Surgery of Hip Fracture in the Elderly

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