Hyperosmolar Saline Irrigation Fluid in Arthroscopic Knee Surgery

Arthroscopic Knee Surgery Clinical Trial

— Salty Knee  

Official title:

Safety and Efficacy of Hyperosmolar Saline Irrigation Fluid in Arthroscopic Knee Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03564886
• Other study ID #: 2011296
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2019
• Est. completion date: September 5, 2019

Study information

• Verified date: August 2020
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 5, 2019
• Est. primary completion date: September 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroscopic Knee Surgery

Intervention

Drug:
• Hyperosmolar Saline
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)

Locations

Country	Name	City	State
United States	University of Missouri Health System	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postoperative Pain	To determine if a hyperosmolar solution has any effect on post-operative knee pain (Visual Analogue Scale; 0-10; 0= no pain; 10= worst pain imaginable) compared to the standard isotonic solution.	Post-operative Days 1, 2 and 3
Secondary	Opioid Consumption	To determine if a hyperosmolar solution has any effect on post-operative pain medicine consumption compared to the standard isotonic solution.	Postoperative Days 1, 2 and 3.