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Patients scheduled for breast surgery due to cancer. Each patient will be treated with intravenous (i.v.) oxycodone - patient-controlled analgesia (PCA). Patients will be allocated to one of three groups: erector spinae plane (ESP) block, sham block, controlled group.
Only patients who are qualified for an elective procedure of mitral breast surgery may participate in the study. Each patient will be anesthetized generally. The same drugs will be used in each stage of anesthesia. The induction: propofol, fentanyl, rocuronium. The airway will be secured with a laryngeal mask airway (LMA). When there is a risk of aspiration, the patient will be intubated. Then, rocuronium or suxamethonium will be used. The anesthesia maintenance: sevoflurane, fentanyl. The emergence: oxygen, sugammadex or neostigmine a required.
After the induction of general anesthesia, an opaque envelope with the selected group will be opened. In the controlled group, the procedure will be continued in the patient's supine position. Women from the ESP and Sham groups will be placed in the lateral position. The operated side will be above. Then, the ultrasound-guided ESP block with saline or ropivacaine will be performed.
At the end of the surgery, an anesthesiologist will administer oxycodone intravenously (0.1 mg/KG).
After emergence from anesthesia, the patient will be transferred to the postoperative care unit. Vital signs will be monitored. The patient-controlled analgesia pump with oxycodone will be used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controlled | Placebo Comparator | Standard care without regional block. General anesthesia. After the end of the surgery, the patient-controlled analgesia with oxycodone. |
|
| ESP block | Experimental | After the induction of general anesthesia, before the beginning of the surgery, the erector spinae plane block with 0.375% ropivacaine will be performed. Then, the patient will be treated as in the controlled group. |
|
| Sham block | Sham Comparator | After the induction of general anesthesia, before the beginning of the surgery, the erector spinae plane block with 0.9% saline will be performed. Then, the patient will be treated as in the controlled group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erector spinae plane block | Procedure | Ultrasound-guided the erector spinae plane block with 0.375% ropivacaine, 0.4 mL per KG, up to 40 mL (maximum dose). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of recovery 40 | Quality of recovery (QoR) score containing 40 items. This questionnaire measures the early postoperative health status of patients. Minimum is 40, maximum is 200. More points is better. | Before the hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-controlled analgesia (PCA) | All good and bad demands with PCA pump. | 24 hours from the connection of the PCA pump in the post-anesthesia care unit. |
| Visual analog scale | Acute pain measured with VAS (visual analog scale). From 0 (no pain) to 100. More on the scale is worse. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paweł Piwowarczyk, MD-PhD | Medical University of Lublin | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| II Department of Anesthesia and Intensive Care, Medical University of Lublin | Lublin | 20-081 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35836116 | Derived | Wiech M, Piwowarczyk P, Mieszkowski M, Tuyakov B, Pituch-Sala K, Czarnik T, Kurylcio A, Czuczwar M, Borys M. The quality of recovery after erector spinae plane block in patients undergoing breast surgery: a randomized controlled trial. BMC Anesthesiol. 2022 Jul 14;22(1):222. doi: 10.1186/s12871-022-01760-z. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| D016058 | Analgesia, Patient-Controlled |
| D010323 | Passive Cutaneous Anaphylaxis |
| D010098 | Oxycodone |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D000698 | Analgesia |
| D012882 | Skin Tests |
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Patients will be randomized 1:1:1
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The patient: The primary intervention (erector spinae plane block) will be provided under general anesthesia.
The investigator and outcome assessor will be not aware of the allocation.
|
| Sham block | Procedure | Ultrasound-guided the erector spinae plane block with 0.9% saline, 0.4 mL per KG, up to 40 mL (maximum dose). |
|
| General anesthesia | Procedure | Standard general anesthesia. The induction with fentanyl, 1-3 mcg per KG; propofol, 1.5-2 mg per kg. Then, the laryngeal mask airway will be inserted. Patients with the risk of aspiration will be intubated using rocuronium or suxamethonium. The maintenance with oxygen/air mixture, sevoflurane, and fentanyl. |
|
|
| Patient-controlled analgesia | Procedure | All patients will receive a PCA pump with oxycodone (1 mg/mL, 5-minute interval) after transfer to PACU (post-anesthesia care unit) |
|
|
| Oxycodone | Drug | Intravenous oxycodone will be administered about 30 minutes before the end of the surgery at a dose of 0.1 mg/KG. Additional 2 doses can be given if pain on the visual analog scale will be higher than 40. |
|
| paracetamol | Drug | intravenous paracetamol will be used (1.0 gram), up to 4 grams per day |
|
| up to 24 hours after the surgery |
| Total oxycodone consumption | Consumption of oxycodone with PCA pump, loading, and additional doses. | up to 24 hours after the surgery |
| D017437 |
| Skin and Connective Tissue Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| 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 |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |