Hyperosmolar Saline Irrigation Fluid in Arthroscopic Knee Surgery

NCT ID: NCT03564886

Last Updated: 2020-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2019-09-05

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

Study Design

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

Study Groups

Hyperosmolar Saline

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

Group Type: EXPERIMENTAL

Hyperosmolar Saline

Intervention Type: DRUG

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

Normal Saline

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.

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

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

Interventions

Hyperosmolar Saline

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

Intervention Type: DRUG

Normal saline

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

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

Sponsors

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

James Stannard

Hansjörg Wyss Distinguished Chair in Orthopaedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James P Stannard, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

University of Missouri Health System

Columbia, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

2011296

Identifier Type: -

Identifier Source: org_study_id