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NCT03564886 · ClinicalTrials.gov registry record · Phase 4
Hyperosmolar Saline Irrigation Fluid in Arthroscopic Knee Surgery
A Phase 4 study, sponsored by University of Missouri-Columbia.
- Completed
- Registry status
- Phase 4
- Development phase
- 48
- Enrollment target
NCT03564886 is a Phase 4 study that has completed, run by University of Missouri-Columbia. The registered enrollment target is 48 participants.
The verdict
NCT03564886, a Phase 4 study, has completed, sponsored by University of Missouri-Columbia.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 48 participants
- Enrollment target
Study 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
- DRUG Normal saline
- DRUG Hyperosmolar Saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2019-01-01 |
| Est. Completion | 2019-09-05 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03564886
The ClinicalTrials.gov registry entry for NCT03564886 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Missouri-Columbia, which has 291 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Normal saline is the first listed.
NCT03564886 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03564886 about?
NCT03564886 is a clinical study titled "Hyperosmolar Saline Irrigation Fluid in Arthroscopic Knee Surgery". 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...
What is the current status of trial NCT03564886?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 48 participants. The study started on 2019-01-01. Estimated completion is 2019-09-05.
What interventions are being tested in trial NCT03564886?
The interventions under investigation include: Normal saline (DRUG), Hyperosmolar Saline (DRUG).
Who is sponsoring clinical trial NCT03564886?
This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.
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