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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Patients will receive standard of care lactated ringer's solution for the arthroscopic irrigation during surgery. | |
| Intervention | Experimental | Patients will receive hyperosmolar saline for the arthroscopic irrigation during surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypertonic saline | Drug | 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. |
| 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 |
| 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 |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liam Kane, BS | Contact | 2673393593 | Liam.Kane@rothmanortho.com | |
| Thema Nicholson | Contact | 2673393615 | thema.nicholson@rothmanortho.com |
| Name | Affiliation | Role |
|---|---|---|
| Ryan Cox, MD | Thomas Jefferson University | Principal Investigator |
| Daniel Davis, MD | Rothman Orthopaedics | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28318850 | Background | 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. | |
| 25725966 | Background | 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. |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D012462 | Saline Solution, Hypertonic |
| ID | Term |
|---|---|
| D006982 | Hypertonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| 6 weeks, 3 months, 6 months |
| Active range of motion | Active range of motion | 3 months, 6 months |