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Currently the prevalent approach to perioperative management of patients is ERAS (Enhanced Recovery After Surgery) concept. This approach includes numerous aspects, among which the perioperative use of multimodal analgesia takes one of the leading places. Within the ERAS guidelines all sorts of minimization of opioid analgesics use in schemes of postoperative analgesia are appreciated. Thus, new pharmacological approaches are being actively developed currently in order to achieve adequate analgesia and to minimize the use of this group of drugs.
One of the most perspective trends within the multimodal analgesia concept is continuous infusion of non-steroidal anti-inflammatory drugs (NSAID). Up to date there are papers that both confirm the effectiveness of this method for maintaining adequate postoperative analgesia and show its limitations and deny the advantages of the continuous use of NSAID.
Up to this time the main attention of the medical community was paid for such drugs as paracetamol and ketoprofen. Nevertheless, one of the most common and safe NSAID is ibuprofen. In spite of this, there are no studies that explore the effectiveness of the continuous infusion of this drug. Thus, the lack of even low-quality evidence led to setting up a study of effectiveness and safety of continuous infusion of ibuprofen in comparison to its bolus injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NSAID bolus injection | Active Comparator |
| |
| NSAID continuous infusion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen continuous infusion | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption | Evaluation of the overall consumption of opioid analgesics after surgery during the whole postoperative period | up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity assessment | Evaluation of postoperative pain intensity using the Numerical Rating Scale (NRS); measurements at regular intervals and before rescue analgesia if pain exceeds NRS >5. The maximum value is 10, the minimum value is 0. The higher the value, the more severe patient's pain (worse). | From admission to ICU until 48 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| NSAID-related Adverse Effects | Incidence and severity of adverse effects including respiratory depression, gastrointestinal dysfunction, hepatotoxicity, renal dysfunction, allergic reactions, and CNS effects. | up to 28 days |
| Length of ICU stay |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valery Likhvantsev, PhD | Contact | +79036235982 | lik0704@gmail.com | |
| Kristina Kadantseva, PhD | Contact | +79168306947 | kristina161093@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Valery Likhvantsev, PhD | Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City Clinical Hospital named after S.S. Yudin | Recruiting | Moscow | Moscow Oblast | 115446 | Russia |
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|
| Ibuprofen bolus injection | Drug |
Between the boluses a placebo (0,9% NaCl) continuous intravenous infusion is performed with the speed imitating the speed of ibuprofen infusion in the experimental group. |
|
The number of days between the day of discharge from the ICU (or in-hospital death) after initial admission and the day of randomization.
| 1 year |
| Length of Hospital Stay | The number of days between the day of discharge from the hospital (or in-hospital death) after initial admission and the day of randomization. | 1 year |
| ICU Readmission | Incidence of readmission to the intensive care unit within 28 days from the day of randomization. | Within 28 days from randomization |
| In-hospital mortality | Number of patients who die from any cause during initial hospitalization | 1 year |
| 28-days mortality | Number of patients who die from any cause within28 days after randomization | From randomization to 28 days |
| 6-month mortality | Number of patients who die from any cause within 6 months after randomization | From randomization to 6 months |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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