search
Back to results

How Much is Too Much: Assessing Varying Pressure Pump Pressures in Post Operative Pain Control in Shoulder Arthroscopy.

Primary Purpose

Shoulder Arthroscopy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Arthroscopic rotator cuff repair
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Arthroscopy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients attending St. Joseph's hospital
  • Shoulder pathology amenable to arthroscopic surgery
  • Medically suitable for surgical management
  • Able to consent for surgery.

Exclusion Criteria:

  • Unable to consent
  • Active infection
  • Active malignancy
  • Drug or alcohol misuse
  • Work related injury
  • Lack of permanent home residence
  • Previous surgery to affected shoulder
  • Medical contraindiction to surgery
  • Pregnant women

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    25mmHg pressure

    45mmHg pressure

    65mmHg pressure

    Arm Description

    Pump pressure of 25mmHg during rotator cuff repair

    Pump pressure of 45mmHg during rotator cuff repair

    Pump pressure of 65mmHg during rotator cuff repair

    Outcomes

    Primary Outcome Measures

    Pain - VAS scale

    Secondary Outcome Measures

    Full Information

    First Posted
    September 7, 2016
    Last Updated
    September 7, 2016
    Sponsor
    Lawson Health Research Institute
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02896959
    Brief Title
    How Much is Too Much: Assessing Varying Pressure Pump Pressures in Post Operative Pain Control in Shoulder Arthroscopy.
    Official Title
    How Much is Too Much: Assessing Varying Pressure Pump Pressures in Post Operative Pain Control in Shoulder Arthroscopy.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2016 (undefined)
    Primary Completion Date
    June 2019 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Lawson Health Research Institute

    4. Oversight

    5. Study Description

    Brief Summary
    Postoperative surgical pain has been extensively study with regard to anaesthesia pain modalities, however little is published with regards to various arthroscopic shoulder surgical techniques. An intriguing characteristic of shoulder arthroscopy is the various arthroscopic pump pressures used by different surgeons. One could hypothesize that excessive water retention from the arthroscopic pump could causes excessive tissue pressure and swelling resulting in post operative pain. Unfortunately we could not find any literature in the English language regarding varying pressure pump settings on post operative pain control. For that reason we would like to assess how variable pump pressure effect tissue pressure over pre set time points, and how this may relate to post operative pain control.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Shoulder Arthroscopy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    25mmHg pressure
    Arm Type
    Experimental
    Arm Description
    Pump pressure of 25mmHg during rotator cuff repair
    Arm Title
    45mmHg pressure
    Arm Type
    Experimental
    Arm Description
    Pump pressure of 45mmHg during rotator cuff repair
    Arm Title
    65mmHg pressure
    Arm Type
    Experimental
    Arm Description
    Pump pressure of 65mmHg during rotator cuff repair
    Intervention Type
    Procedure
    Intervention Name(s)
    Arthroscopic rotator cuff repair
    Primary Outcome Measure Information:
    Title
    Pain - VAS scale
    Time Frame
    Two years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients attending St. Joseph's hospital Shoulder pathology amenable to arthroscopic surgery Medically suitable for surgical management Able to consent for surgery. Exclusion Criteria: Unable to consent Active infection Active malignancy Drug or alcohol misuse Work related injury Lack of permanent home residence Previous surgery to affected shoulder Medical contraindiction to surgery Pregnant women

    12. IPD Sharing Statement

    Learn more about this trial

    How Much is Too Much: Assessing Varying Pressure Pump Pressures in Post Operative Pain Control in Shoulder Arthroscopy.

    We'll reach out to this number within 24 hrs