Trial Outcomes & Findings for Hyperosmolar Saline Irrigation Fluid in Arthroscopic Knee Surgery (NCT NCT03564886)

NCT ID: NCT03564886

Last Updated: 2020-08-21

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 48 participants
• Primary outcome timeframe: Immediately Postoperatively
• Results posted on: 2020-08-21

Participant Flow

Participant milestones

Measure	Hyperosmolar Saline 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.	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. Normal saline: Lactate Ringer's (LR, 273mOsm/L)
Overall Study STARTED	24	24
Overall Study COMPLETED	23	23
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Hyperosmolar Saline n=23 Participants 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.	Normal Saline n=23 Participants 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 n=46 Participants Total of all reporting groups
Age, Continuous	40.2 years STANDARD_DEVIATION 12.5 • n=23 Participants	44.0 years STANDARD_DEVIATION 13.8 • n=23 Participants	42.1 years STANDARD_DEVIATION 13.2 • n=46 Participants
Sex: Female, Male Female	15 Participants n=23 Participants	12 Participants n=23 Participants	27 Participants n=46 Participants
Sex: Female, Male Male	8 Participants n=23 Participants	11 Participants n=23 Participants	19 Participants n=46 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Body Mass Index	30.4 kg/m^2 STANDARD_DEVIATION 7.1 • n=23 Participants	31.7 kg/m^2 STANDARD_DEVIATION 6.9 • n=23 Participants	31.0 kg/m^2 STANDARD_DEVIATION 7.0 • n=46 Participants

PRIMARY outcome

Timeframe: Immediately Postoperatively

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

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.

Outcome measures

Measure	Hyperosmolar Saline n=23 Participants 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.	Normal Saline n=23 Participants 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)
Fluid Extravasation	1.8 centimeters Standard Deviation 1.1	1.2 centimeters Standard Deviation 1.1

SECONDARY outcome

Timeframe: Post-operative Days 1, 2 and 3

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

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.

Outcome measures

Measure	Hyperosmolar Saline n=23 Participants 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.	Normal Saline n=23 Participants 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)
Postoperative Pain VAS Pain PostOp Day 2	3.8 units on a scale Standard Deviation 1.7	4.8 units on a scale Standard Deviation 2.5
Postoperative Pain VAS Pain PostOp Day 1	4.9 units on a scale Standard Deviation 2.0	4.8 units on a scale Standard Deviation 2.0
Postoperative Pain VAS Pain PostOp Day 3	3.6 units on a scale Standard Deviation 1.9	3.8 units on a scale Standard Deviation 1.7

SECONDARY outcome

Timeframe: Postoperative Days 1, 2 and 3.

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

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

Outcome measures

Measure	Hyperosmolar Saline n=23 Participants 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.	Normal Saline n=23 Participants 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)
Opioid Consumption Medication PostOp Day 1	17.0 morphine equivalent units Standard Deviation 14.9	23.6 morphine equivalent units Standard Deviation 18.3
Opioid Consumption Medication PostOp Day 2	15.0 morphine equivalent units Standard Deviation 19.7	19.5 morphine equivalent units Standard Deviation 18.4
Opioid Consumption Medication PostOp Day 3	4.0 morphine equivalent units Standard Deviation 7.6	15.5 morphine equivalent units Standard Deviation 17.4

Adverse Events

Hyperosmolar Saline

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Normal Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Hyperosmolar Saline n=23 participants at risk 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.	Normal Saline n=23 participants at risk 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)
Vascular disorders Deep Vein Thrombosis (DVT)	4.3% 1/23 • Number of events 1 • 30 Days 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.	0.00% 0/23 • 30 Days 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.

Additional Information

Lasun Oladeji, MD

University of Missouri, Department of Orthopaedics

Phone: 573-884-7796

Email: OladejiL@health.missouri.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place