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A comparison of the analgesic efficacy of pericapsular nerve group blocking vs periarticular injection after total hip arthroplaslty - Prospective study -

Status Approved

  • First Submitted Date

    2021/02/17

  • Registered Date

    2021/03/31

  • Last Updated Date

    2021/02/17

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0006049
    Unique Protocol ID CNUH 2020-04-013
    Public/Brief Title A comparison of the analgesic efficacy of pericapsular nerve group blocking vs periarticular injection after total hip arthroplaslty - Prospective study -
    Scientific Title A comparison of the analgesic efficacy of pericapsular nerve group blocking vs periarticular injection after total hip arthroplaslty - Prospective study -
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number CNUH 2020-04-013
    Approval Date 2020-07-16
    Institutional Review Board Name Chungnam National University Hospital Institutional Review Board
    Institutional Review Board Address 282, Munhwa-ro, Jung-gu, Daejeon
    Institutional Review Board Telephone 042-280-8715
    Data Monitoring Committee
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Deuk Soo Hwang
    Title Professor
    Telephone +82-42-338-2480
    Affiliation Chungnam National University Hospital
    Address Chungnam National University Hospital, 282 Munwha-ro, Jung-gu, Daejeon 35015, Republic of Korea
    Contact Person for Public Queries
    Name Jeong Kil Lee
    Title Professor
    Telephone +82-42-338-2480
    Affiliation Chungnam National University Sejong Hospital
    Address 20, Bodeum 7-ro, Sejong-si, Republic of Korea
    Contact Person for Updating Information
    Name Jeong Kil Lee
    Title Professor
    Telephone +82-42-338-2480
    Affiliation Chungnam National University Sejong Hospital
    Address 20, Bodeum 7-ro, Sejong-si, Republic of Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Active, not recruiting
    Date of First Enrollment 2020-07-16 Actual
    Target Number of Participant 60
    Primary Completion Date 2021-02-28 , Anticipated
    Study Completion Date 2021-02-28 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Chungnam National University Hospital
    Recruitment Status Active, not recruiting
    Date of First Enrollment 2020-07-16 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Chungnam National University Hospital
    Organization Type Medical Institute
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Chungnam National University Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Pain after surgery is one of the most common reasons for delayed discharge. The pain of total hip arthroplasty is so severe that it may not only cause pain to the patient after surgery, but may also lead to fear of surgery. Pain can slow the recovery of joint motion after rehabilitation and surgery, which may lead to less than expected range of motion, and fear of surgery may interfere with the formation of a relationship between the patient and the doctor. For this reason, various methods have been attempted to reduce postoperative pain, but there is no established method due to utility problems and side effects. In this study, the effect of postoperative pain control in patients who underwent total hip arthroplasty surgery compared the group who underwent preoperative Nerve block surgery around the joint capsule and the group who underwent an anesthetic injection into the joint capsule during surgery. The goal is to find a more effective postoperative pain control method by performing an anesthetic injection into the joint capsule, which has already proven effective in total hip arthroplasty, and setting it as a comparative group, and setting the recently emerged nerve group blockage around the hip as an experimental group.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Single
    Blinded Subject Subject
    Allocation RCT
    Intervention Type /Procedure/Surgery  
    Intervention Description
    An anesthetic in the experimental group was injected between the psoas tendon and the pubic ramus with a mixture of 20 ml of ropivacaine and 10 ml of normal saine while watching ultrasound. The mixture of the comparative group is prepared by mixing 20 ml of ropivacaine, 2 ml of ketorolac, and 1 ml of epinephrine with physiological saline to make 100 cc and dividing into two 50 cc syringes. Inject it into the subcutaneous before skin incision, into the posterior capsule before capsectomy, and into the anterior capsule before inserting the femoral stem. After surgery, before stitching the surgical site, the remaining mixture is injected into the soft tissue around the surgical site and layer by layer suture is performed.
    Number of Arms 2
    Arm 1

    Arm Label

    Experimental group

    Target Number of Participant

    30

    Arm Type

    Experimental

    Arm Description

    An anesthetic in the experimental group was injected between the psoas tendon and the pubic ramus with a mixture of 20 ml of ropivacaine and 10 ml of normal saine while watching ultrasound.
    Arm 2

    Arm Label

    Comparative group

    Target Number of Participant

    30

    Arm Type

    Active comparator

    Arm Description

    The mixture of the comparative group is prepared by mixing 20 ml of ropivacaine, 2 ml of ketorolac, and 1 ml of epinephrine with physiological saline to make 100 cc and dividing into two 50 cc syringes. Inject it into the subcutaneous before skin incision, into the posterior capsule before capsectomy, and into the anterior capsule before inserting the femoral stem. After surgery, before stitching the surgical site, the remaining mixture is injected into the soft tissue around the surgical site and layer by layer suture is performed.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (M00-M99)Diseases of the musculoskeletal system and connective tissue 
       (M25.95)Joint disorder, unspecified, pelvic region and thigh 

    Hip, Osteoarthritis, Hip Replacement
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    18Year~No Limit

    Description

    1) Men and women over 18 years of age
    2) Patients who underwent total hip arthroplasty under the diagnosis of arthritis after the IRB approval date
    3) Patients who have completed the survey among patients admitted to the hospital for more than 48 hours after surgery
    Exclusion Criteria
    1) Patients who were hospitalized for more than 48 hours after surgery and did not faithfully participate in the survey, or were discharged within 48 hours unplanned and failed to complete the survey
    2) Patients who have undergone total hip arthroplasty due to reoperation, infectious disease, or fracture rather than simple total hip arthroplasty.
    3) Patients with side effects related to nerve group blockage before surgery or periarticular capsule injection during surgery
    4) Patients with diseases such as delirium/dementia are excluded
    5) If the patient does not agree to participate in the test
    Healthy Volunteers Yes
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome clinical-equivalence
    Primary Outcome(s) 1
    Outcome
    Statistically analyzed whether there was a significant difference in the degree of pain reduction between the experimental group and the control group.
    Timepoint
    Measure and evaluate the change in pain score for 48 hours after surgery
    Secondary Outcome(s) 1
    Outcome
    Statistical analysis was made to see if there was a significant difference in the quality of recovery between the experimental group and the control group, and whether the shortening of hospitalization period accordingly occurred.
    Timepoint
    Measure the quality of recovery after surgery and evaluate the hospitalization period until discharge
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Yes
    Time of Sharing 2021. 12
    Way of Sharing To be made available at a later date
    (myhomejungle@hanmail.net)
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