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Preoperative Fluoroscopy Guided Hip Articular Branch Blocks and Analgesic Outcomes Following Hip Arthroscopy

Primary Purpose

Surgery, Arthroscopic, Analgesia, Pain, Acute

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Control
Articular Branch Block (ABB)
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgery, Arthroscopic focused on measuring hip arthroscopy, articular branch block

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Presenting for Hip Arthroscopy (Diagnostic or Therapeutic)
  • Pre-operative Numeric Rating Score (NRS) for pain <8 on a 0 to 10 scale where 0 is no pain and 10 is worst pain imaginable.

Exclusion Criteria:

  • Allergies to any of the study medications
  • Anti-coagulation status (INR > 1.1, PT or APTT > 1.5 control)
  • History of Hip Arthroplasty
  • Infection of Hip
  • Evidence of tumor
  • Pregnancy
  • History of diabetes with HbA1c > 10%
  • Prior history of Hip Articular Branch Blockade or Hip Articular Branch PRF Ablation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Sham Comparator

    Experimental

    Arm Label

    Sham Injection

    Articular Branch Block (ABB)

    Arm Description

    20cc of Normal Saline 0.9%

    20cc of 0.5% Bupivacaine with epinephrine 1:200,000

    Outcomes

    Primary Outcome Measures

    NRS Pain Scores (NRS)
    Numerical Rating Scale is a self-reported pain assessment, in which a patient indicates their current pain level experienced. Patients can rate their pain on a scale of 0 (no pain) to 10 (worse pain imaginable). Higher scores indicated on this scale may indicate that a patient is experiencing higher pain intensities at that particular point in time. Whereas lower reported scores indicate that the patient is experiencing less intense or minimal pain.

    Secondary Outcome Measures

    The QOR-15 (Quality of Recovery)
    Quality of Recovery scores will be obtained 24 hours post-operatively. Scores are reported on an 11 point scale (0 to 10), where 0 = none of the time and 10 = all of the time. Higher scores indicated on the Quality of Recovery scale represent a better recovery outcome.
    Analgesic medication use

    Full Information

    First Posted
    August 17, 2020
    Last Updated
    September 13, 2021
    Sponsor
    Rush University Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04538105
    Brief Title
    Preoperative Fluoroscopy Guided Hip Articular Branch Blocks and Analgesic Outcomes Following Hip Arthroscopy
    Official Title
    Preoperative Fluoroscopy Guided Hip Articular Branch Blocks and Analgesic Outcomes Following Hip Arthroscopy: A Randomized, Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study cancelled
    Study Start Date
    May 1, 2021 (Anticipated)
    Primary Completion Date
    October 1, 2021 (Anticipated)
    Study Completion Date
    October 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rush University Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Arthroscopic hip surgeries are increasingly being performed as both diagnostic and therapeutic interventions. These procedures are considerably painful, thus requiring the proper pain management techniques in order to provide patient satisfaction and sufficient pain control. Articular branch blocks have not been evaluated for their use in hip arthroscopy, but have potential advantages of blocking the sensory innervation of the entire hip joint, with minimal impact on motor innervation compared to alternative blocks. This current study aims to evaluate the efficacy of using preoperative fluoroscopic-guided blockade of articular branches of the femoral and obturator nerves for analgesic management of patients undergoing arthroscopy compared to a saline sham block. The utility of pre-operative hip articular branch block (ABB) prior to hip arthroscopy will provide superior pain management postoperatively compared to a saline sham block. We hypothesize that the ABB (Articular Branch Block) will reduce the area under the NRS pain scores by time curve (AUC) and decreased oral opioid milligram equivalent use in the first 24 hours post-operatively.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Surgery, Arthroscopic, Analgesia, Pain, Acute
    Keywords
    hip arthroscopy, articular branch block

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Sham Injection
    Arm Type
    Sham Comparator
    Arm Description
    20cc of Normal Saline 0.9%
    Arm Title
    Articular Branch Block (ABB)
    Arm Type
    Experimental
    Arm Description
    20cc of 0.5% Bupivacaine with epinephrine 1:200,000
    Intervention Type
    Other
    Intervention Name(s)
    Control
    Intervention Description
    Saline Articular Nerve Branch Block
    Intervention Type
    Other
    Intervention Name(s)
    Articular Branch Block (ABB)
    Intervention Description
    0.5% Bupivacaine with epinephrine 1:200,000 (Articular Branch Block)
    Primary Outcome Measure Information:
    Title
    NRS Pain Scores (NRS)
    Description
    Numerical Rating Scale is a self-reported pain assessment, in which a patient indicates their current pain level experienced. Patients can rate their pain on a scale of 0 (no pain) to 10 (worse pain imaginable). Higher scores indicated on this scale may indicate that a patient is experiencing higher pain intensities at that particular point in time. Whereas lower reported scores indicate that the patient is experiencing less intense or minimal pain.
    Time Frame
    24 hours post-operatively
    Secondary Outcome Measure Information:
    Title
    The QOR-15 (Quality of Recovery)
    Description
    Quality of Recovery scores will be obtained 24 hours post-operatively. Scores are reported on an 11 point scale (0 to 10), where 0 = none of the time and 10 = all of the time. Higher scores indicated on the Quality of Recovery scale represent a better recovery outcome.
    Time Frame
    24 hours post-operatively
    Title
    Analgesic medication use
    Time Frame
    24 hours post-operatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Presenting for Hip Arthroscopy (Diagnostic or Therapeutic) Pre-operative Numeric Rating Score (NRS) for pain <8 on a 0 to 10 scale where 0 is no pain and 10 is worst pain imaginable. Exclusion Criteria: Allergies to any of the study medications Anti-coagulation status (INR > 1.1, PT or APTT > 1.5 control) History of Hip Arthroplasty Infection of Hip Evidence of tumor Pregnancy History of diabetes with HbA1c > 10% Prior history of Hip Articular Branch Blockade or Hip Articular Branch PRF Ablation

    12. IPD Sharing Statement

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    Preoperative Fluoroscopy Guided Hip Articular Branch Blocks and Analgesic Outcomes Following Hip Arthroscopy

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