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Surgical Dressings After Endoscopic Carpal Tunnel Release

Primary Purpose

Carpal Tunnel Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bandaid
Conventional bulky soft tissue dressing
Sponsored by
Chris Grandizio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients 18 years of age or older
  2. Patients undergoing primary, elective, unilateral ECTR under monitored anesthesia care with local anesthesia.

Exclusion Criteria:

  1. Patients undergoing ECTR as part of a worker's compensation case
  2. Patients currently incarcerated
  3. Subject who cannot read and speak English

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Conventional post-operative bulky soft tissue dressing

    Bandaid post-operative dressing

    Arm Description

    Intraoperative: MAC-Local Anesthesia; Local anesthetic mixture will be distributed in both the subcutaneous tissue and within the carpal canal Postoperative: Non-opioid medications only; Conventional post-operative bulky soft tissue dressing (Xeroform, 4x4s, Webril, Ace Wrap; Worn until first postoperative visit)

    Intraoperative: MAC-Local Anesthesia; Local anesthetic mixture will be distributed in both the subcutaneous tissue and within the carpal canal Postoperative: Non-opioid medications only; Bandaid over incision (Patient given an edema glove to wear starting post-operative day 1; Dressing change be changed post-operative day 2 and as needed after that)

    Outcomes

    Primary Outcome Measures

    Visual Analog Scale Pain Score
    best 0-10 worst; continuous scale to measure current pain level

    Secondary Outcome Measures

    Boston Carpal Tunnel Questionnaire
    ranges from 1 to 5, with a higher score indicating greater disability; -specific measure of self-reported symptom severity and functional status
    PROMIS Pain Interference
    best 0-100 worst; measures the effects of a patient's pain on their daily activities and lifestyle
    PROMIS Self-Efficacy Manage Symptoms
    best 0-100 worst; measures a patient's ability to cope with their symptoms related to the procedure
    PROMIS Upper Extremity
    worst 0-100 best; measures physical function of upper extremities
    QuickDASH
    best 0-100 worst; functional outcome score for disabilities of the arm, shoulder, and hand
    number of participants with unscheduled healthcare contact
    unscheduled healthcare contact includes patient calls/messages, emergency room visits, or scheduled clinic visits
    morphine equivalents
    morphine equivalents consumed for post-operative pain control
    number of participants with complications
    complications after surgery including infection and delayed healing
    Satisfaction with overall outcome
    11 point Likert scale; worst 0-10 best
    Satisfaction postoperative pain control
    11 point Likert scale; worst 0-10 best
    Satisfaction with the dressing
    11 point Likert scale; worst 0-10 best
    Grip Strength Measurement
    Using Jamar Hand Dynamometer, in kilograms ranging from worst 0-90 best

    Full Information

    First Posted
    August 24, 2019
    Last Updated
    March 28, 2023
    Sponsor
    Chris Grandizio
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04070924
    Brief Title
    Surgical Dressings After Endoscopic Carpal Tunnel Release
    Official Title
    Surgical Dressings After Endoscopic Carpal Tunnel Release: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    June 2024 (Anticipated)
    Study Completion Date
    June 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Chris Grandizio

    4. Oversight

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

    5. Study Description

    Brief Summary
    Carpal tunnel syndrome (CTS) is the most common compressive neuropathy in the upper extremity. While carpal tunnel release (CTR), both open (OCTR) and endoscopic (ECTR), is safe and effective, there are questions regarding the use of postoperative dressings after surgery. It is not currently known if dressing choices influence post-operative pain, function or patient satisfaction after ECTR. A less cumbersome dressing (bandaid) may allow patients to perform daily tasks with more ease after surgery. The purpose of this investigation is to compare postoperative pain scores and patient satisfaction after ECTR for patients treated with conventional post-operative bulky soft tissue dressings versus those treated with a bandaid after surgery. The hypothesis is that patients using a bandaid after surgery will have an easier time with functional tasks after surgery and that pain scores will not significantly differ between the two groups. Furthermore, this study aims to determine if there are differences in patient satisfaction, functional outcomes, complications, and unscheduled healthcare contact between these two groups. This will be a randomized, controlled investigation.
    Detailed Description
    Carpal tunnel syndrome (CTS) is the most common compressive neuropathy in the upper extremity. While carpal tunnel release (CTR), both open (OCTR) and endoscopic (ECTR), is safe and effective, there are questions regarding the use of postoperative dressings after surgery. With recent attention to the opioid epidemic, there have been increasing efforts to reduce narcotic usage postoperatively while still controlling expected postoperative pain. Recent authors have found that many patients, particularly older patients, do not require any opioid analgesia after CTR with 47% of men and 36% of women consuming no narcotics after CTR (CHAPMAN). Furthermore, while splints have historically been used after surgery, their need has recently been questioned (LOGLI). It is not currently known if dressing choices influence post-operative pain, function or patient satisfaction after ECTR. A less cumbersome dressing (bandaid) may allow patients to perform daily tasks with more ease after surgery. The purpose of this investigation is to compare postoperative pain scores and patient satisfaction after ECTR for patients treated with conventional post-operative bulky soft tissue dressings versus those treated with a bandaid after surgery. The hypothesis is that patients using a bandaid after surgery will have an easier time with functional tasks after surgery and that pain scores will not significantly differ between the two groups. Furthermore, this study aims to determine if there are differences in patient satisfaction, functional outcomes, complications, and unscheduled healthcare contact between these two groups. This will be a randomized, controlled investigation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carpal Tunnel Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Conventional post-operative bulky soft tissue dressing
    Arm Type
    Active Comparator
    Arm Description
    Intraoperative: MAC-Local Anesthesia; Local anesthetic mixture will be distributed in both the subcutaneous tissue and within the carpal canal Postoperative: Non-opioid medications only; Conventional post-operative bulky soft tissue dressing (Xeroform, 4x4s, Webril, Ace Wrap; Worn until first postoperative visit)
    Arm Title
    Bandaid post-operative dressing
    Arm Type
    Experimental
    Arm Description
    Intraoperative: MAC-Local Anesthesia; Local anesthetic mixture will be distributed in both the subcutaneous tissue and within the carpal canal Postoperative: Non-opioid medications only; Bandaid over incision (Patient given an edema glove to wear starting post-operative day 1; Dressing change be changed post-operative day 2 and as needed after that)
    Intervention Type
    Other
    Intervention Name(s)
    Bandaid
    Intervention Description
    Bandaid dressing
    Intervention Type
    Other
    Intervention Name(s)
    Conventional bulky soft tissue dressing
    Intervention Description
    Conventional bulky soft tissue dressing
    Primary Outcome Measure Information:
    Title
    Visual Analog Scale Pain Score
    Description
    best 0-10 worst; continuous scale to measure current pain level
    Time Frame
    0-12 months
    Secondary Outcome Measure Information:
    Title
    Boston Carpal Tunnel Questionnaire
    Description
    ranges from 1 to 5, with a higher score indicating greater disability; -specific measure of self-reported symptom severity and functional status
    Time Frame
    0-12 months
    Title
    PROMIS Pain Interference
    Description
    best 0-100 worst; measures the effects of a patient's pain on their daily activities and lifestyle
    Time Frame
    0-12 months
    Title
    PROMIS Self-Efficacy Manage Symptoms
    Description
    best 0-100 worst; measures a patient's ability to cope with their symptoms related to the procedure
    Time Frame
    0-12 months
    Title
    PROMIS Upper Extremity
    Description
    worst 0-100 best; measures physical function of upper extremities
    Time Frame
    0-12 months
    Title
    QuickDASH
    Description
    best 0-100 worst; functional outcome score for disabilities of the arm, shoulder, and hand
    Time Frame
    0-12 months
    Title
    number of participants with unscheduled healthcare contact
    Description
    unscheduled healthcare contact includes patient calls/messages, emergency room visits, or scheduled clinic visits
    Time Frame
    0-12 months
    Title
    morphine equivalents
    Description
    morphine equivalents consumed for post-operative pain control
    Time Frame
    0-12 months
    Title
    number of participants with complications
    Description
    complications after surgery including infection and delayed healing
    Time Frame
    0-12 months
    Title
    Satisfaction with overall outcome
    Description
    11 point Likert scale; worst 0-10 best
    Time Frame
    0-12 months
    Title
    Satisfaction postoperative pain control
    Description
    11 point Likert scale; worst 0-10 best
    Time Frame
    0-12 months
    Title
    Satisfaction with the dressing
    Description
    11 point Likert scale; worst 0-10 best
    Time Frame
    0-12 months
    Title
    Grip Strength Measurement
    Description
    Using Jamar Hand Dynamometer, in kilograms ranging from worst 0-90 best
    Time Frame
    0-12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients 18 years of age or older Patients undergoing primary, elective, unilateral ECTR under monitored anesthesia care with local anesthesia. Exclusion Criteria: Patients undergoing ECTR as part of a worker's compensation case Patients currently incarcerated Subject who cannot read and speak English
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Christopher Grandizio, MD
    Phone
    570-271-5555
    Ext
    54033
    Email
    lcgrandizio@geisinger.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kenneth Sams
    Phone
    570-214-6178
    Email
    kbsams@geisinger.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Christopher Grandizio, MD
    Organizational Affiliation
    Geisinger Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Surgical Dressings After Endoscopic Carpal Tunnel Release

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