Hyperosmolar Saline Irrigation Fluid in Arthroscopic Knee Surgery

NCT03564886 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2011296
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

An isotonic solution, such as saline (0.9%, 300mOsm/L) or lactated ringer's (273 mOsm/L), is commonly used and safely proven for joint irrigation during arthroscopy. Arthroscopic fluid is usually pressurized to enable visualization through dilation of the joint or bursa and prevent bleeding from the microvasculature. It has been recommended that this pressure be maintained at 49mmHg or less below the systolic blood pressure to preserve the clarity of view. The combination of large amounts of pressurized irrigation solution and lengthy arthroscopic procedures may cause substantial tissue fluid retention. Thus, extravasation of irrigation fluid into the periarticular tissues is inevitable and may create technical difficulties as well as patient morbidity and complications. Previous investigators have reported complications including tracheal obstruction, post-operative airway edema and compromise leading to prolonged intubation, excess weight gain, neurologic injuries, skin necrosis, and fluid overload associated with excessive fluid extravasation and tissue retention. Furthermore, it has been shown that fluid accumulated during the operation is slowly released back into the systemic circulation. Although there is not a rapid change in circulating volume, there may be implications for elderly patients and those with multiple comorbidities during prolonged arthroscopic surgery. Therefore the investigators seek to determine if a hyperosmolar solution, similar to what is used in head trauma patients, can reduce the degree of fluid extravasation in knee arthroscopy. The investigators also seek to determine if a hyperosmolar solution has any effect on post-operative knee pain compared to the standard isotonic solution. The third objective is to determine if a hyperosmolar solution has any effect on post-operative pain medicine consumption compared to the standard isotonic solution.

Conditions

Arthroscopic Knee Surgery

Outcome Measures

Primary Outcomes (1)

• Fluid Extravasation

  To determine if a hyperosmolar solution, similar to what is used in head trauma patients, can change the degree of fluid extravasation in knee arthroscopy.

  Immediately Postoperatively

Secondary Outcomes (2)

• Postoperative Pain

  Post-operative Days 1, 2 and 3

• Opioid Consumption

  Postoperative Days 1, 2 and 3.

Study Arms (2)

Hyperosmolar Saline

EXPERIMENTAL

The hyperosmolar solution will be created by adding 120cc of 23.4% NS solution to a 3L bag of LR.

Drug: Hyperosmolar Saline

Normal Saline

PLACEBO COMPARATOR

Lactate Ringer's (LR, 273mOsm/L) is commonly used at our facility as our isotonic standard irrigation solution and will serve as the control to be evaluated against a hyperosmolar (1.9%, 600mOsm) solution.

Drug: Normal saline

Interventions

Hyperosmolar Saline DRUG

The hyperosmolar solution will be created by adding 120cc of 23.4% NS solution to a 3L bag of LR.

Hyperosmolar Saline

Normal saline DRUG

Lactate Ringer's (LR, 273mOsm/L)

Normal Saline

Eligibility Criteria

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

You may qualify if:

• Adult patients (18 years of age or greater) undergoing arthroscopic knee surgery who are willing and able to consent.

You may not qualify if:

• Current pregnancy or breastfeeding
• Unable to give consent
• Prisoner
• Mentally Disabled

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri Health System

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Lasun Oladeji, MD
• Organization: University of Missouri, Department of Orthopaedics

OladejiL@health.missouri.edu

573-884-7796

Study Officials

• James P Stannard, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hansjörg Wyss Distinguished Chair in Orthopaedic Surgery

Study Record Dates

• First Submitted: June 8, 2018
• First Posted: June 21, 2018
• Study Start: January 1, 2019
• Primary Completion: September 5, 2019
• Study Completion: September 5, 2019
• Last Updated: August 21, 2020
• Results First Posted: August 10, 2020

Record last verified: 2020-08

Locations

US (1)