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Caudal Block & Hip Fracture Surgery in Anticoagulated Patient

Sponsor
Salem Anaesthesia Pain Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05946863
Collaborator
(none)
100
Enrollment
1
Location
191.9
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Hip fractures are common in elderly patients, and require surgery. Many elderly patients take anticoagulants for vasculopathy treatment. Anticoagulation precludes the use of neuraxial anesthesia because of the risk of epidural bleeding. Caudal anesthesia may be a safe and effective technique in anticoagulated emergency surgical patients.

Quantitative analysis of prospective clinical data. Evaluation of caudal anesthesia efficacy for hip fracture surgery. Analysis of perioperative outcome, and postoperative course.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Hip or femoral neck fractures are common in elderly patients. These fractures require surgical repair. Many elderly patients take regular anticoagulant therapy for vasculopathy. Anticoagulation precludes the use of spinal or epidural anesthesia because of the risk of epidural bleeding. Caudal anesthesia is another form of neuraxial anesthesia that may be safe and effective for hip fracture surgery in anticoagulated elderly patients.

    Quantitative analysis of prospective clinical data. It is an evaluation of caudal anesthesia efficacy for hip fracture surgery. This is an analysis of intraoperative analgesia, perioperative outcome, postoperative course, and complications.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Caudal Anesthesia for Surgical Repair of Fractured Hip or Femoral-neck in Anticoagulated Patients
    Actual Study Start Date :
    Jan 2, 2008
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Pain score, objective measurement using the validated Numeric Pain Rating scale [1 month]

      Pain score, using the Numeric Pain Rating scale of 0 to 10, low scores indicate less pain, high scores indicate worse pain

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Patients with fractured hip or femoral neck who undergo surgical repair
    Exclusion Criteria:
    • Patients who refuse surgical repair

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Salem Anaesthesia Pain Clinic Surrey British Columbia Canada V3S 7J1

    Sponsors and Collaborators

    • Salem Anaesthesia Pain Clinic

    Investigators

    • Principal Investigator: Olu Bamgbade, MD,FRCPC, Salem Anaesthesia Pain Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Salem Anaesthesia Pain Clinic
    ClinicalTrials.gov Identifier:
    NCT05946863
    Other Study ID Numbers:
    • Salem2017 Caudal Blk NOF Surg
    First Posted:
    Jul 14, 2023
    Last Update Posted:
    Jul 17, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Salem Anaesthesia Pain Clinic
    Caudal anesthesia
    Additional relevant MeSH terms:
    Hemostatic Disorders
    Blood Coagulation Disorders
    Hip Fractures

    Study Results

    No Results Posted as of Jul 17, 2023