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Post Operative Pain Control for Distal Radius Surgery: Does Exparel Injected at the Surgery Site Improve Postoperative Pain Scores at 24 and 48 Hours ?

Primary Purpose

Post Operative Pain

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Group A (Exparel plus supraclavicular block)
Group B (Bupivacaine HCL plus supraclavicular block)
Group C(supraclavicular block only)
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring Brachial plexus block, Multimodal pain control for Distal Radius surgery, Exparel, Bupivacaine, Distal Radius Pain Control, Post operative pain Control, Supraclavicular nerve block

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • distal radius fractures
  • undergoing Open reduction internal fixation (ORIF) at Lyndon B Johnson Ambulatory Surgical Center (LBJ ASC)

Exclusion Criteria:

  • pregnancy
  • history of chronic pain conditions
  • currently taking opioids

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    Exparel plus supraclavicular block

    Bupivacaine HCL plus supraclavicular block

    supraclavicular block only

    Arm Description

    Outcomes

    Primary Outcome Measures

    Pain as measured by the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R)
    The questionnaire consists of 13 questions.The first 11 is scored form 0-10(a higher number indicating a worse outcome).
    Pain as measured by the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R)
    The questionnaire consists of 13 questions.The first 11 is scored form 0-10(a higher number indicating a worse outcome).

    Secondary Outcome Measures

    Number of patients who presented to Emergency room following surgery for pain control
    Number of patients who presented to Emergency room following surgery for pain control
    Number of over the counter(OTC) pain medications consumed by the patient
    Number of OTC pain medications consumed by the patient
    Number of prescription opioid medications consumed by the patient
    Number of prescription opioid medications consumed by the patient

    Full Information

    First Posted
    August 31, 2020
    Last Updated
    October 27, 2021
    Sponsor
    The University of Texas Health Science Center, Houston
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04540848
    Brief Title
    Post Operative Pain Control for Distal Radius Surgery: Does Exparel Injected at the Surgery Site Improve Postoperative Pain Scores at 24 and 48 Hours ?
    Official Title
    Post Operative Pain Control for Distal Radius Surgery: Does Exparel Injected at the Surgery Site Improve Postoperative Pain Scores at 24 and 48 Hours ?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Lack of ability to communicate with the study population
    Study Start Date
    March 1, 2021 (Anticipated)
    Primary Completion Date
    November 20, 2021 (Anticipated)
    Study Completion Date
    November 20, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The University of Texas Health Science Center, Houston

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to see if Exparel, used intraoperatively by injecting at the surgical site, followed by a Supraclavicular nerve block with bupivacaine in the recovery room, will provide better pain scores for patients at 24 and 48 hours post operatively than, 1)Bupivacaine Hydrochloride (HCL) injection at the surgical site, with a supraclavicular block in Post-anesthesia care unit(PACU), or 2)a supraclavicular block in PACU without any kind of injection at the surgical site.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post Operative Pain
    Keywords
    Brachial plexus block, Multimodal pain control for Distal Radius surgery, Exparel, Bupivacaine, Distal Radius Pain Control, Post operative pain Control, Supraclavicular nerve block

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Exparel plus supraclavicular block
    Arm Type
    Experimental
    Arm Title
    Bupivacaine HCL plus supraclavicular block
    Arm Type
    Active Comparator
    Arm Title
    supraclavicular block only
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Group A (Exparel plus supraclavicular block)
    Intervention Description
    Patients will receive 20 cc (266 mg) of Exparel injected in the distal radius area and a supraclavicular block in the recovery room.The supraclavicular blocks will be ultrasound guided and consist of 20 cc of Bupivacaine HCl 0.25% .Anesthesiologist performing the block will be instructed to surround the brachial plexus with the local anesthetic, taking special care to inject in the "corner pocket".
    Intervention Type
    Drug
    Intervention Name(s)
    Group B (Bupivacaine HCL plus supraclavicular block)
    Intervention Description
    Patients will receive 20 cc of Bupivacaine 0.25% (50mg) in the distal radius area.In the recovery room the patient will be given the supraclavicular block which will be ultrasound guided and consisting of 20 cc of Bupivacaine HCl 0.25% .Anesthesiologist performing the block will be instructed to surround the brachial plexus with the local anesthetic, taking special care to inject in the "corner pocket".
    Intervention Type
    Drug
    Intervention Name(s)
    Group C(supraclavicular block only)
    Intervention Description
    In the recovery room the patient will be given the supraclavicular block which will be ultrasound guided and consisting of 20 cc of Bupivacaine HCl 0.25% .Anesthesiologist performing the block will be instructed to surround the brachial plexus with the local anesthetic, taking special care to inject in the "corner pocket".
    Primary Outcome Measure Information:
    Title
    Pain as measured by the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R)
    Description
    The questionnaire consists of 13 questions.The first 11 is scored form 0-10(a higher number indicating a worse outcome).
    Time Frame
    24 hours post treatment
    Title
    Pain as measured by the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R)
    Description
    The questionnaire consists of 13 questions.The first 11 is scored form 0-10(a higher number indicating a worse outcome).
    Time Frame
    48 hours post treatment
    Secondary Outcome Measure Information:
    Title
    Number of patients who presented to Emergency room following surgery for pain control
    Time Frame
    24 hours post surgery
    Title
    Number of patients who presented to Emergency room following surgery for pain control
    Time Frame
    48 hours post surgery
    Title
    Number of over the counter(OTC) pain medications consumed by the patient
    Time Frame
    24 hours post surgery
    Title
    Number of OTC pain medications consumed by the patient
    Time Frame
    48 hours post surgery
    Title
    Number of prescription opioid medications consumed by the patient
    Time Frame
    24 hours post surgery
    Title
    Number of prescription opioid medications consumed by the patient
    Time Frame
    48 hours post surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: distal radius fractures undergoing Open reduction internal fixation (ORIF) at Lyndon B Johnson Ambulatory Surgical Center (LBJ ASC) Exclusion Criteria: pregnancy history of chronic pain conditions currently taking opioids
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Erikka L Washington, MD
    Organizational Affiliation
    The University of Texas Health Science Center, Houston
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Post Operative Pain Control for Distal Radius Surgery: Does Exparel Injected at the Surgery Site Improve Postoperative Pain Scores at 24 and 48 Hours ?

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