Salty Knee: Hyperosmolar Saline Irrigation Fluid in Arthroscopic Knee Surgery

• Sponsor: University of Missouri-Columbia (Other)
• Overall Status: Completed
• CT.gov ID: NCT03564886
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.1
• Patients Per Site Per Month: 5.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arthroscopic Knee Surgery	Drug: Hyperosmolar Saline; Drug: Normal saline	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy of Hyperosmolar Saline Irrigation Fluid in Arthroscopic Knee Surgery
• Actual Study Start Date: Jan 1, 2019
• Actual Primary Completion Date: Sep 5, 2019
• Actual Study Completion Date: Sep 5, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hyperosmolar Saline The hyperosmolar solution will be created by adding 120cc of 23.4% NS solution to a 3L bag of LR.	Drug: Hyperosmolar Saline; The hyperosmolar solution will be created by adding 120cc of 23.4% NS solution to a 3L bag of LR.
Placebo Comparator: 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.	Drug: Normal saline; Lactate Ringer's (LR, 273mOsm/L)

Outcome Measures

Primary Outcome Measures

1. Fluid Extravasation [Immediately Postoperatively]

   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.

Secondary Outcome Measures

1. Postoperative Pain [Post-operative Days 1, 2 and 3]

   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.

2. Opioid Consumption [Postoperative Days 1, 2 and 3.]

   To determine if a hyperosmolar solution has any effect on post-operative pain medicine consumption compared to the standard isotonic solution.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Missouri Health System	Columbia	Missouri	United States	65212

Sponsors and Collaborators

• University of Missouri-Columbia

Investigators

• Principal Investigator: James P Stannard, MD, University of Missouri-Columbia

Study Documents (Full-Text)

• Study Protocol - Apr 3, 2019

More Information

Publications

None provided.

• Responsible Party: James Stannard, Hansjörg Wyss Distinguished Chair in Orthopaedic Surgery, University of Missouri-Columbia
• ClinicalTrials.gov Identifier: NCT03564886
• Other Study ID Numbers: 2011296
• First Posted: Jun 21, 2018
• Last Update Posted: Aug 21, 2020
• Last Verified: Aug 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Study Results

Participant Flow

Arm/Group Title	Hyperosmolar Saline	Normal Saline
Arm/Group Description	The hyperosmolar solution will be created by adding 120cc of 23.4% NS solution to a 3L bag of LR. Hyperosmolar Saline: The hyperosmolar solution will be created by adding 120cc of 23.4% NS solution to a 3L bag of LR.	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. Normal saline: Lactate Ringer's (LR, 273mOsm/L)
Period Title: Overall Study
STARTED	24	24
COMPLETED	23	23
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Hyperosmolar Saline	Normal Saline	Total
Arm/Group Description	The hyperosmolar solution will be created by adding 120cc of 23.4% NS solution to a 3L bag of LR. Hyperosmolar Saline: The hyperosmolar solution will be created by adding 120cc of 23.4% NS solution to a 3L bag of LR.	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. Normal saline: Lactate Ringer's (LR, 273mOsm/L)	Total of all reporting groups
Overall Participants	23	23	46
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.2 (12.5)	44.0 (13.8)	42.1 (13.2)
Sex: Female, Male (Count of Participants)
Female	15 65.2%	12 52.2%	27 58.7%
Male	8 34.8%	11 47.8%	19 41.3%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	30.4 (7.1)	31.7 (6.9)	31.0 (7.0)

Outcome Measures

1. Primary Outcome

Title	Fluid Extravasation
Description	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.
Time Frame	Immediately Postoperatively

Outcome Measure Data

Analysis Population Description

Change in Knee Girth (cm)= Postoperative knee girth- preoperative knee girth

Arm/Group Title	Hyperosmolar Saline	Normal Saline
Arm/Group Description	The hyperosmolar solution will be created by adding 120cc of 23.4% NS solution to a 3L bag of LR. Hyperosmolar Saline: The hyperosmolar solution will be created by adding 120cc of 23.4% NS solution to a 3L bag of LR.	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. Normal saline: Lactate Ringer's (LR, 273mOsm/L)
Measure Participants	23	23
Mean (Standard Deviation) [centimeters]	1.8 (1.1)	1.2 (1.1)

2. Secondary Outcome

Title	Postoperative Pain
Description	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.
Time Frame	Post-operative Days 1, 2 and 3

Outcome Measure Data

Analysis Population Description

Visual Analogue Score (0-10) for the first three postoperative days.

Arm/Group Title	Hyperosmolar Saline	Normal Saline
Arm/Group Description	The hyperosmolar solution will be created by adding 120cc of 23.4% NS solution to a 3L bag of LR. Hyperosmolar Saline: The hyperosmolar solution will be created by adding 120cc of 23.4% NS solution to a 3L bag of LR.	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. Normal saline: Lactate Ringer's (LR, 273mOsm/L)
Measure Participants	23	23
VAS Pain PostOp Day 1	4.9 (2.0)	4.8 (2.0)
VAS Pain PostOp Day 2	3.8 (1.7)	4.8 (2.5)
VAS Pain PostOp Day 3	3.6 (1.9)	3.8 (1.7)

3. Secondary Outcome

Title	Opioid Consumption
Description	To determine if a hyperosmolar solution has any effect on post-operative pain medicine consumption compared to the standard isotonic solution.
Time Frame	Postoperative Days 1, 2 and 3.

Outcome Measure Data

Analysis Population Description

Pain medication consumption on postoperative days 1, 2, and 3 as measured in morphine equivalent units

Arm/Group Title	Hyperosmolar Saline	Normal Saline
Arm/Group Description	The hyperosmolar solution will be created by adding 120cc of 23.4% NS solution to a 3L bag of LR. Hyperosmolar Saline: The hyperosmolar solution will be created by adding 120cc of 23.4% NS solution to a 3L bag of LR.	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. Normal saline: Lactate Ringer's (LR, 273mOsm/L)
Measure Participants	23	23
Medication PostOp Day 1	17.0 (14.9)	23.6 (18.3)
Medication PostOp Day 2	15.0 (19.7)	19.5 (18.4)
Medication PostOp Day 3	4.0 (7.6)	15.5 (17.4)

Adverse Events

Time Frame	30 Days
Adverse Event Reporting Description	A member of the research team was responsible for documenting any perioperative adverse events that occurred prior to discharge. A retrospective review of the electronic medical records was performed to identify any adverse events that occurred within the first 30 days following surgery.
Arm/Group Title	Hyperosmolar Saline		Normal Saline
Arm/Group Description	The hyperosmolar solution will be created by adding 120cc of 23.4% NS solution to a 3L bag of LR. Hyperosmolar Saline: The hyperosmolar solution will be created by adding 120cc of 23.4% NS solution to a 3L bag of LR.		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. Normal saline: Lactate Ringer's (LR, 273mOsm/L)
All Cause Mortality
	Hyperosmolar Saline		Normal Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/23 (0%)
Serious Adverse Events
	Hyperosmolar Saline		Normal Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/23 (0%)
Other (Not Including Serious) Adverse Events
	Hyperosmolar Saline		Normal Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/23 (4.3%)		0/23 (0%)
Vascular disorders
Deep Vein Thrombosis (DVT)	1/23 (4.3%)	1	0/23 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.