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

Rothman Institute Orthopaedics

Status and phase: Unknown; Phase 4

Conditions: Rotator Cuff Tear; Arthroscopic Shoulder Surgery

Treatments: Drug: Hypertonic saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03738735

2018Davis

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Control

No Intervention group

Description:

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

Intervention

Experimental group

Description:

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

Treatment:

Drug: Hypertonic saline