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

NCT03738735 | Unknown Phase 4 FDA Drug

• 1 other identifier: 2018Davis
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Visual Analogue Scale

  pain rated on scale of 1-10

  daily for 14 days post-operatively

• Morphine equivalent

  opiod comsumption

  weekly for first 2 weeks post-operatively

Secondary Outcomes (3)

• American Shoulder Elbow Surgeons standardized shoulder assessment form

  3 months and 6 months

• Passive range of motion

  6 weeks, 3 months, 6 months

• Active range of motion

  3 months, 6 months

Study Arms (2)

Control

NO INTERVENTION

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

Intervention

EXPERIMENTAL

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

Drug: Hypertonic saline

Interventions

Hypertonic saline 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.

Intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years of age
• Patients undergoing arthroscopic rotator cuff repair of full thickness, one or two tendon tears

You may not qualify if:

• 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

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Related 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.

  PMID: 28318850 BACKGROUND

• 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.

  PMID: 25725966 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Saline Solution, Hypertonic

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ryan Cox, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

• Daniel Davis, MD

  Rothman Orthopaedics

  STUDY DIRECTOR

Central Study Contacts

Liam Kane, BS

CONTACT

2673393593; Liam.Kane@rothmanortho.com

Thema Nicholson

CONTACT

2673393615; thema.nicholson@rothmanortho.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 13, 2018
• Study Start: January 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: June 1, 2020
• Last Updated: November 13, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share