Last reviewed · How we verify
Hyperosmolar Saline Irrigation Fluid in Arthroscopic Knee Surgery
Phase 4 trial testing Hyperosmolar Saline in Arthroscopic Knee Surgery in 48 participants. Completed in 5 September 2019.
| Lead sponsor | University of Missouri-Columbia |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 48 |
| Start date | 1 January 2019 |
| Primary completion | 5 September 2019 |
| Estimated completion | 5 September 2019 |
| Sites | 1 location across United States |
University of Missouri-Columbia
18 and older, any sex, with Arthroscopic Knee Surgery. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Hyperosmolar Saline | 1.8 | ± 1.1 |
| Normal Saline | 1.2 | ± 1.1 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Hyperosmolar Saline | 4.9 | ± 2.0 |
| Normal Saline | 4.8 | ± 2.0 |
| Group | Value | 95% CI |
|---|---|---|
| Hyperosmolar Saline | 3.8 | ± 1.7 |
| Normal Saline | 4.8 | ± 2.5 |
| Group | Value | 95% CI |
|---|---|---|
| Hyperosmolar Saline | 3.6 | ± 1.9 |
| Normal Saline | 3.8 | ± 1.7 |
To determine if a hyperosmolar solution has any effect on post-operative pain medicine consumption compared to the standard isotonic solution.
| Group | Value | 95% CI |
|---|---|---|
| Hyperosmolar Saline | 17.0 | ± 14.9 |
| Normal Saline | 23.6 | ± 18.3 |
| Group | Value | 95% CI |
|---|---|---|
| Hyperosmolar Saline | 15.0 | ± 19.7 |
| Normal Saline | 19.5 | ± 18.4 |
| Group | Value | 95% CI |
|---|---|---|
| Hyperosmolar Saline | 4.0 | ± 7.6 |
| Normal Saline | 15.5 | ± 17.4 |
Time frame: 30 Days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Hyperosmolar Saline | Normal Saline |
|---|---|---|---|
| Deep Vein Thrombosis (DVT) | Vascular disorders | — | — |
Data from ClinicalTrials.gov NCT03564886 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03564886.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing