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| Name | Class |
|---|---|
| University of Rzeszow | OTHER |
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Patients scheduled for minimally invasive mitral valve replacement. Each patient will be treated with intravenous (i.v.) oxycodone - patient-controlled analgesia (PCA). Half of the patients will be randomly allocated to Erector Spinae Plane (ESP) blockade group.
Only patients who are qualified for an elective procedure of mitral valve replacement may participate in the study. Each patient will be anesthetized generally. The same drugs will be used in each stage of anesthesia. The induction: etomidate, remifentanil, rocuronium, scolina as required. The maintenance: sevoflurane, remifentanil, rocuronium. The emergence: oxygen, sugammadex or neostigmine a required.
Patients will be randomly allocated into one of two groups: PCA or ESP. Among the patients from ESP group will have ESP blockade before the induction of general anesthesia. ESP blockade will be performed under ultrasound control. A single-shot technique will be used with 0.375 % solution of ropivacaine: 0.2 mL per patients' KG. The maximum dose is 40 mL.
Each patient, before the end of surgery, will be administered i.v. 0.1 mg of oxycodone. PCA with oxycodone (1mg/mL) will be utilized during the postoperative period: 5-minute interval. This is standard protocol in our department.
Only patients who are successfully awakened after the procedure may participate in the study.
The pain intensity will be assessed with visual-analogue scale (VAS) at 2, 4, 8, 12 and 24 hour after the end of anesthesia.
The total consumption of oxycodone will be also monitored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESP | Experimental | Before the induction of general anesthesia, Erector Spinae Plane (ESP) blockade will be done. Postoperative analgesia is provided with intravenous oxycodone. Patient-controlled analgesia pump (PCA) will be used for this purpose. |
|
| PCA | Experimental | Postoperative analgesia is provided with intravenous oxycodone. Patient-controlled analgesia pump (PCA) will be used for this purpose. ESP will not be done in this arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erector Spinae Plane blockade | Procedure | Before the beginning of the procedure, ESP blockade will be performed under ultrasound control. A single-shot technique will be used with 0.375 % solution of ropivacaine: 0.2 mL per patients' KG. The maximum dose is 40 mL. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Patients' self-pain assessment with VAS (visual-analogue scale) | From the end of anesthesia till 24 hour postoperatively. VAS range from 0 (no pain, good outcome) to 100 in millimeters (the worst pain ever, bad outcome). |
| Measure | Description | Time Frame |
|---|---|---|
| Total consumption of oxycodone | The cumulative consumption of oxycodone during 24 hour from the end of anesthesia. | From the end of anesthesia till 24 hour postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mirosław Czuczwar, M.D., PhD | Medical University of Lublin | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Jadwiga Hospital | Rzeszów | 35-501 | Poland |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| D010323 | Passive Cutaneous Anaphylaxis |
| D000768 | Anesthesia, General |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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Parallel Assignment
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Single (Participant)
|
| Oxycodone | Drug | Each patient, before the end of surgery, will be administered i.v. 0.1 mg of oxycodone. PCA with oxycodone (1mg/mL) will be utilized during the postoperative period: 5-minute interval. |
|
|
| general anesthesia | Procedure | Each patient will generally anesthetized and endotracheal tube will be inserted |
|
|
| paracetamol | Drug | Paracetamol will be given i.v. every 6 hours. |
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D012882 | Skin Tests |
| D007159 | Immunologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
| D000937 | Antigen-Antibody Reactions |
| D055633 | Immune System Phenomena |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |