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

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Double Blinded, Randomized Control Trial on Effect of Hyperosmlar Saline in Reducing Postoperative Pain Following Arthroscopic Rotator Cuff Repair

Conditions
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Arthroscopic Shoulder Surgery, Rotator Cuff Tear

Intervention / Treatment
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* Drug: Hypertonic saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Patients will receive standard of care lactated ringer's solution for the arthroscopic irrigation during surgery. | |
| Experimental: Intervention<br>Patients will receive hyperosmolar saline for the arthroscopic irrigation during surgery. | Drug: Hypertonic saline<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale | pain rated on scale of 1-10 | daily for 14 days post-operatively | 
| Morphine equivalent | opiod comsumption | weekly for first 2 weeks post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Shoulder Elbow Surgeons standardized shoulder assessment form | shoulder function | 3 months and 6 months | 
| Passive range of motion | passive range of motion | 6 weeks, 3 months, 6 months | 
| Active range of motion | Active range of motion | 3 months, 6 months |