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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperosmolar Saline | Experimental | The hyperosmolar solution will be created by adding 120cc of 23.4% NS solution to a 3L bag of LR. |
|
| Normal Saline | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperosmolar Saline | Drug | The hyperosmolar solution will be created by adding 120cc of 23.4% NS solution to a 3L bag of LR. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Opioid Consumption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James P Stannard, MD | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri Health System | Columbia | Missouri | 65212 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Normal Saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Change in Knee Girth (cm)= Postoperative knee girth- preoperative knee girth | Posted | Mean | Standard Deviation | centimeters | Immediately Postoperatively |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep Vein Thrombosis (DVT) | Vascular disorders | Non-systematic Assessment | Post-operative DVT |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lasun Oladeji, MD | University of Missouri, Department of Orthopaedics | 573-884-7796 | OladejiL@health.missouri.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 3, 2019 | Jul 24, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Normal saline | Drug | Lactate Ringer's (LR, 273mOsm/L) |
|
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. |
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) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
|
|
| 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. | Visual Analogue Score (0-10) for the first three postoperative days. | Posted | Mean | Standard Deviation | units on a scale | 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. | Pain medication consumption on postoperative days 1, 2, and 3 as measured in morphine equivalent units | Posted | Mean | Standard Deviation | morphine equivalent units | Postoperative Days 1, 2 and 3. |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 1 |
| 23 |
| EG001 | 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) | 0 | 23 | 0 | 23 | 0 | 23 |
|
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| VAS Pain PostOp Day 3 |
|
| Medication PostOp Day 3 |
|