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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03738735
Recruitment Status : Unknown
Verified November 2018 by Rothman Institute Orthopaedics.
Recruitment status was:  Not yet recruiting
First Posted : November 13, 2018
Last Update Posted : November 13, 2018
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

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.

Condition or disease Intervention/treatment Phase
Arthroscopic Shoulder Surgery Rotator Cuff Tear Drug: Hypertonic saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Prospective, Double Blinded, Randomized Control Trial on Effect of Hyperosmlar Saline in Reducing Postoperative Pain Following Arthroscopic Rotator Cuff Repair
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Control
Patients will receive standard of care lactated ringer's solution for the arthroscopic irrigation during surgery.
Experimental: Intervention
Patients will receive hyperosmolar saline for the arthroscopic irrigation during surgery.
Drug: Hypertonic saline
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 Measures :
  1. Visual Analogue Scale [ Time Frame: daily for 14 days post-operatively ]
    pain rated on scale of 1-10

  2. Morphine equivalent [ Time Frame: weekly for first 2 weeks post-operatively ]
    opiod comsumption

Secondary Outcome Measures :
  1. American Shoulder Elbow Surgeons standardized shoulder assessment form [ Time Frame: 3 months and 6 months ]
    shoulder function

  2. Passive range of motion [ Time Frame: 6 weeks, 3 months, 6 months ]
    passive range of motion

  3. Active range of motion [ Time Frame: 3 months, 6 months ]
    Active range of motion

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03738735

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Contact: Liam Kane, BS 2673393593
Contact: Thema Nicholson 2673393615

Sponsors and Collaborators
Rothman Institute Orthopaedics
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Principal Investigator: Ryan Cox, MD Thomas Jefferson University
Study Director: Daniel Davis, MD Rothman Orthopaedics
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Responsible Party: Rothman Institute Orthopaedics Identifier: NCT03738735    
Other Study ID Numbers: 2018Davis
First Posted: November 13, 2018    Key Record Dates
Last Update Posted: November 13, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Wounds and Injuries
Shoulder Injuries
Tendon Injuries