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

Phase 4

• Conditions: Arthroscopic Shoulder Surgery; Rotator Cuff Tear
• Interventions: Drug: Hypertonic saline

• Registration Number: NCT03738735
• Lead Sponsor: Rothman Institute Orthopaedics

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-11
• Study First Submitted: 2018-11-08
• Study First Submitted QC: 2018-11-08
• Last Update Submitted: 2018-11-08
• Study First Posted: 2018-11-13
• Last Update Posted: 2018-11-13
• Study Start: 2019-01
• Primary Completion: 2020-01
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Hypertonic saline	Patients will receive hyperosmolar saline for the arthroscopic irrigation during surgery.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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