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.|
|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Arthroscopic Shoulder Surgery Rotator Cuff Tear||Drug: Hypertonic saline||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
No Intervention: Control
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.
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.
- Visual Analogue Scale [ Time Frame: daily for 14 days post-operatively ]pain rated on scale of 1-10
- Morphine equivalent [ Time Frame: weekly for first 2 weeks post-operatively ]opiod comsumption
- American Shoulder Elbow Surgeons standardized shoulder assessment form [ Time Frame: 3 months and 6 months ]shoulder function
- Passive range of motion [ Time Frame: 6 weeks, 3 months, 6 months ]passive range of motion
- Active range of motion [ Time Frame: 3 months, 6 months ]Active range of motion
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 ClinicalTrials.gov identifier (NCT number): NCT03738735
|Contact: Liam Kane, BS||2673393593||Liam.Kane@rothmanortho.com|
|Contact: Thema Nicholsonfirstname.lastname@example.org|
|Principal Investigator:||Ryan Cox, MD||Thomas Jefferson University|
|Study Director:||Daniel Davis, MD||Rothman Orthopaedics|