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Randomized, Controlled Trial of Hyperosmotlar Saline for Rotator Cuff Repair Irrigation Solution

Primary Purpose

Arthroscopic Shoulder Surgery, Rotator Cuff Tear

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Hypertonic saline
Sponsored by
Rothman Institute Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthroscopic Shoulder Surgery

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age > 18 years of age

Patients undergoing arthroscopic rotator cuff repair of full thickness, one or two tendon tears

Exclusion Criteria:

Patients younger than 18 years of age

Patients who are pregnant, mentally disabled, or imprisoned

Patients not receiving inter-scalene nerve block (catheters excluded)

Patients undergoing labral repair, capsular release, or distal clavicle excision

Patients with irreparable rotator cuff tears

Patients receiving any repair augmentation or graft

Patients with a known hypersensitivity to sodium lacta

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control

    Intervention

    Arm Description

    Patients will receive standard of care lactated ringer's solution for the arthroscopic irrigation during surgery.

    Patients will receive hyperosmolar saline for the arthroscopic irrigation during surgery.

    Outcomes

    Primary Outcome Measures

    Visual Analogue Scale
    pain rated on scale of 1-10
    Morphine equivalent
    opiod comsumption

    Secondary Outcome Measures

    American Shoulder Elbow Surgeons standardized shoulder assessment form
    shoulder function
    Passive range of motion
    passive range of motion
    Active range of motion
    Active range of motion

    Full Information

    First Posted
    November 8, 2018
    Last Updated
    November 8, 2018
    Sponsor
    Rothman Institute Orthopaedics
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03738735
    Brief Title
    Randomized, Controlled Trial of Hyperosmotlar Saline for Rotator Cuff Repair Irrigation Solution
    Official Title
    Prospective, Double Blinded, Randomized Control Trial on Effect of Hyperosmlar Saline in Reducing Postoperative Pain Following Arthroscopic Rotator Cuff Repair
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2019 (Anticipated)
    Primary Completion Date
    January 2020 (Anticipated)
    Study Completion Date
    June 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Rothman Institute Orthopaedics

    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 goal of this project is to perform a randomized, double-blinded study investigating postoperative pain after arthroscopic rotator cuff using hyperosmolar saline as opposed to lactated ringer's solution (normal osmolarity) as arthroscopy irrigation solutions. Hyperosmolar saline is an irrigation solution with a higher concentration of solutes that will be used intraoperatively to washout the surgical field. It will be used in place of lactated ringer's solution, which has an osmolarity comparable to that of normal saline. This study will help determine whether or not postoperative pain from rotator cuff repair can be mitigated by altering the osmolarity of the intraoperative irrigation solution. This knowledge is significant because the postoperative pain can be intense, so much so that patients may depend on narcotics for pain relief. Consequently, this study may provide benefit by helping to find new ways to minimize the need for narcotics. The main hypothesis of this is study is that hyperosmolar saline will reduce perceived pain and narcotic use in the postoperative period.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arthroscopic Shoulder Surgery, Rotator Cuff Tear

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Patients will receive standard of care lactated ringer's solution for the arthroscopic irrigation during surgery.
    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Patients will receive hyperosmolar saline for the arthroscopic irrigation during surgery.
    Intervention Type
    Drug
    Intervention Name(s)
    Hypertonic saline
    Intervention Description
    For the intervention group, the surgical staff will add 120 mL of 23.4% saline to the 3L bags of lactated Ringer's solution, and this new solution will be used for arthroscopic irrigation purposes throughout the rotator cuff repair surgery.
    Primary Outcome Measure Information:
    Title
    Visual Analogue Scale
    Description
    pain rated on scale of 1-10
    Time Frame
    daily for 14 days post-operatively
    Title
    Morphine equivalent
    Description
    opiod comsumption
    Time Frame
    weekly for first 2 weeks post-operatively
    Secondary Outcome Measure Information:
    Title
    American Shoulder Elbow Surgeons standardized shoulder assessment form
    Description
    shoulder function
    Time Frame
    3 months and 6 months
    Title
    Passive range of motion
    Description
    passive range of motion
    Time Frame
    6 weeks, 3 months, 6 months
    Title
    Active range of motion
    Description
    Active range of motion
    Time Frame
    3 months, 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age > 18 years of age Patients undergoing arthroscopic rotator cuff repair of full thickness, one or two tendon tears Exclusion Criteria: Patients younger than 18 years of age Patients who are pregnant, mentally disabled, or imprisoned Patients not receiving inter-scalene nerve block (catheters excluded) Patients undergoing labral repair, capsular release, or distal clavicle excision Patients with irreparable rotator cuff tears Patients receiving any repair augmentation or graft Patients with a known hypersensitivity to sodium lacta
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Liam Kane, BS
    Phone
    2673393593
    Email
    Liam.Kane@rothmanortho.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Thema Nicholson
    Phone
    2673393615
    Email
    thema.nicholson@rothmanortho.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ryan Cox, MD
    Organizational Affiliation
    Thomas Jefferson University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Daniel Davis, MD
    Organizational Affiliation
    Rothman Orthopaedics
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28318850
    Citation
    Capito NM, Cook JL, Yahuaca B, Capito MD, Sherman SL, Smith MJ. Safety and efficacy of hyperosmolar irrigation solution in shoulder arthroscopy. J Shoulder Elbow Surg. 2017 May;26(5):745-751. doi: 10.1016/j.jse.2017.02.021. Epub 2017 Mar 18.
    Results Reference
    background
    PubMed Identifier
    25725966
    Citation
    Capito NM, Smith MJ, Stoker AM, Werner N, Cook JL. Hyperosmolar irrigation compared with a standard solution in a canine shoulder arthroscopy model. J Shoulder Elbow Surg. 2015 Aug;24(8):1243-8. doi: 10.1016/j.jse.2014.12.027. Epub 2015 Feb 25.
    Results Reference
    background

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    Randomized, Controlled Trial of Hyperosmotlar Saline for Rotator Cuff Repair Irrigation Solution

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