Arthroscopic Knee Surgery
Conditions
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.
Interventions
DRUGHyperosmolar Saline
The hyperosmolar solution will be created by adding 120cc of 23.4% NS solution to a 3L bag of LR.
DRUGNormal saline
Lactate Ringer's (LR, 273mOsm/L)
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 23 |
| 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) | 23 |
| Total | 46 |
Baseline characteristics
| Characteristic | Hyperosmolar Saline | Normal Saline | Total |
|---|---|---|---|
| Age, Continuous | 40.2 years STANDARD_DEVIATION 12.5 | 44.0 years STANDARD_DEVIATION 13.8 | 42.1 years STANDARD_DEVIATION 13.2 |
| Body Mass Index | 30.4 kg/m^2 STANDARD_DEVIATION 7.1 | 31.7 kg/m^2 STANDARD_DEVIATION 6.9 | 31.0 kg/m^2 STANDARD_DEVIATION 7 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 15 Participants | 12 Participants | 27 Participants |
| Sex: Female, Male Male | 8 Participants | 11 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 23 |
| other Total, other adverse events | 1 / 23 | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 | 0 / 23 |
Outcome results
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.
Time frame: Immediately Postoperatively
Population: Change in Knee Girth (cm)= Postoperative knee girth- preoperative knee girth
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hyperosmolar Saline | Fluid Extravasation | 1.8 centimeters | Standard Deviation 1.1 |
| Normal Saline | Fluid Extravasation | 1.2 centimeters | Standard Deviation 1.1 |
Secondary
Opioid Consumption
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.
Population: Pain medication consumption on postoperative days 1, 2, and 3 as measured in morphine equivalent units
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hyperosmolar Saline | Opioid Consumption | Medication PostOp Day 1 | 17.0 morphine equivalent units | Standard Deviation 14.9 |
| Hyperosmolar Saline | Opioid Consumption | Medication PostOp Day 2 | 15.0 morphine equivalent units | Standard Deviation 19.7 |
| Hyperosmolar Saline | Opioid Consumption | Medication PostOp Day 3 | 4.0 morphine equivalent units | Standard Deviation 7.6 |
| Normal Saline | Opioid Consumption | Medication PostOp Day 3 | 15.5 morphine equivalent units | Standard Deviation 17.4 |
| Normal Saline | Opioid Consumption | Medication PostOp Day 1 | 23.6 morphine equivalent units | Standard Deviation 18.3 |
| Normal Saline | Opioid Consumption | Medication PostOp Day 2 | 19.5 morphine equivalent units | Standard Deviation 18.4 |
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.
Time frame: Post-operative Days 1, 2 and 3
Population: Visual Analogue Score (0-10) for the first three postoperative days.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hyperosmolar Saline | Postoperative Pain | VAS Pain PostOp Day 1 | 4.9 units on a scale | Standard Deviation 2 |
| Hyperosmolar Saline | Postoperative Pain | VAS Pain PostOp Day 2 | 3.8 units on a scale | Standard Deviation 1.7 |
| Hyperosmolar Saline | Postoperative Pain | VAS Pain PostOp Day 3 | 3.6 units on a scale | Standard Deviation 1.9 |
| Normal Saline | Postoperative Pain | VAS Pain PostOp Day 1 | 4.8 units on a scale | Standard Deviation 2 |
| Normal Saline | Postoperative Pain | VAS Pain PostOp Day 2 | 4.8 units on a scale | Standard Deviation 2.5 |
| Normal Saline | Postoperative Pain | VAS Pain PostOp Day 3 | 3.8 units on a scale | Standard Deviation 1.7 |