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

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03738735
• Other study ID #: 2018Davis
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 2019
• Est. completion date: June 2020

Study information

• Verified date: November 2018
• Source: Rothman Institute Orthopaedics
• Contact: Liam Kane, BS
• Phone: 2673393593
• Email: Liam.Kane[@]rothmanortho.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Arthroscopic Shoulder Surgery
• Rotator Cuff Injuries
• Rotator Cuff Tear

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

References & Publications (2)

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

Outcome

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