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

NCT ID: NCT03738735

Last Updated: 2018-11-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-31
• Study Completion Date: 2020-06-30

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.

Conditions

Arthroscopic Shoulder Surgery; Rotator Cuff Tear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control

Patients will receive standard of care lactated ringer's solution for the arthroscopic irrigation during surgery.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Patients will receive hyperosmolar saline for the arthroscopic irrigation during surgery.

Group Type: EXPERIMENTAL

Hypertonic saline

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rothman Institute Orthopaedics

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryan Cox, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Daniel Davis, MD

Role: STUDY_DIRECTOR

Rothman Orthopaedics

Central Contacts

Liam Kane, BS

Role: CONTACT

Liam.Kane@rothmanortho.com

2673393593

Thema Nicholson

Role: CONTACT

thema.nicholson@rothmanortho.com

2673393615

References

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.

Reference Type: BACKGROUND

PMID: 28318850 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25725966 (View on PubMed)

Other Identifiers

2018Davis

Identifier Type: -

Identifier Source: org_study_id