Rotator Cuff Tear Clinical Trial
Official title:
Prospective, Double Blinded, Randomized Control Trial on Effect of Hyperosmlar Saline in Reducing Postoperative Pain Following Arthroscopic Rotator Cuff Repair
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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | June 2020 |
Est. primary completion date | January 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Rothman Institute Orthopaedics |
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Analogue Scale | pain rated on scale of 1-10 | daily for 14 days post-operatively | |
Primary | Morphine equivalent | opiod comsumption | weekly for first 2 weeks post-operatively | |
Secondary | American Shoulder Elbow Surgeons standardized shoulder assessment form | shoulder function | 3 months and 6 months | |
Secondary | Passive range of motion | passive range of motion | 6 weeks, 3 months, 6 months | |
Secondary | Active range of motion | Active range of motion | 3 months, 6 months |
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