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The Effect of Nerve Blockades in Addition to General Anesthesia in Surgical Fixation of Ankle Fractures.

Primary Purpose

Ankle Fracture in Need of Surgical Fixation

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ropivacaine block
Sponsored by
Herlev Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ankle Fracture in Need of Surgical Fixation

Eligibility Criteria

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

Inclusion Criteria:

  • Age >18 years
  • Patients in need of anaesthesia for operative fixation of ankle fractures.
  • American Society of Anesthesiologists (ASA) score 1-3.
  • BMI > 18 og < 35.
  • Oral and written consent

Exclusion Criteria:

  • Weight < 50kg
  • Allergy towards drugs used in the study
  • Patients for re-operation
  • Other fracture at the same time
  • Pregnancy
  • Daily use of opioids within two weeks before operation
  • Infection near the application site
  • Patients in need of dialysis
  • Patients with neuropathy in lower extremities

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Block

    NaCl

    Arm Description

    Popliteal and saphenous Block with Ropivacaine

    Outcomes

    Primary Outcome Measures

    Use of Morphine

    Secondary Outcome Measures

    Functional rehabilitation outcome
    American Orthopaedic Foot and Ankle Society (AOFAS) score

    Full Information

    First Posted
    August 13, 2013
    Last Updated
    April 2, 2017
    Sponsor
    Herlev Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01923623
    Brief Title
    The Effect of Nerve Blockades in Addition to General Anesthesia in Surgical Fixation of Ankle Fractures.
    Official Title
    The Effect of Combined Popliteal and Saphenous Block in Addition to General Anesthesia in Surgical Fixation of Ankle Fractures: a Prospective Randomized Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study was redesigned and taken over by a ph.D-student
    Study Start Date
    July 1, 2013 (Actual)
    Primary Completion Date
    July 1, 2013 (Actual)
    Study Completion Date
    July 31, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Herlev Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This clinical, randomized, and controlled study will provide valuable scientific evidence regarding the effect of adding peripheral nerve blockades to general anaesthesia during ankle surgery. In particular, the investigators want to determine if the need for postoperative opioids will be reduced and whether this will lead to shorter admission to recovery room and fewer instances of side effects such as postoperative nausea and vomiting. In addition, the investigators will determine whether the functional outcome is improved i.e. faster and more successful rehabilitation. This would have profound benefits not only to the individual patient but also to society by reducing expenses during admission, the cost of sick leave etc.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ankle Fracture in Need of Surgical Fixation

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Block
    Arm Type
    Experimental
    Arm Description
    Popliteal and saphenous Block with Ropivacaine
    Arm Title
    NaCl
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Ropivacaine block
    Primary Outcome Measure Information:
    Title
    Use of Morphine
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    Functional rehabilitation outcome
    Description
    American Orthopaedic Foot and Ankle Society (AOFAS) score
    Time Frame
    10-14 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age >18 years Patients in need of anaesthesia for operative fixation of ankle fractures. American Society of Anesthesiologists (ASA) score 1-3. BMI > 18 og < 35. Oral and written consent Exclusion Criteria: Weight < 50kg Allergy towards drugs used in the study Patients for re-operation Other fracture at the same time Pregnancy Daily use of opioids within two weeks before operation Infection near the application site Patients in need of dialysis Patients with neuropathy in lower extremities
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rune Sort, M.D.
    Organizational Affiliation
    Herlev Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Ann M. Møller, Dr.med.
    Organizational Affiliation
    Herlev Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    The Effect of Nerve Blockades in Addition to General Anesthesia in Surgical Fixation of Ankle Fractures.

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