Arthroscopic Shoulder Surgery, Rotator Cuff Tear
Conditions
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.
Interventions
DRUGHypertonic 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.
Sponsors
Rothman Institute Orthopaedics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale | daily for 14 days post-operatively | pain rated on scale of 1-10 |
| Morphine equivalent | weekly for first 2 weeks post-operatively | opiod comsumption |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder Elbow Surgeons standardized shoulder assessment form | 3 months and 6 months | shoulder function |
| Passive range of motion | 6 weeks, 3 months, 6 months | passive range of motion |
| Active range of motion | 3 months, 6 months | Active range of motion |
Contacts
Primary ContactLiam Kane, BS
Backup ContactThema Nicholson
Outcome results
None listed