Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
75 participants
INTERVENTIONAL
2021-02-01
2021-08-17
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
The investigator and outcome assessor will be not aware of the allocation.
Study Groups
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Controlled
Standard care without regional block. General anesthesia. After the end of the surgery, the patient-controlled analgesia with oxycodone.
General anesthesia
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
All patients will receive a PCA pump with oxycodone (1 mg/mL, 5-minute interval) after transfer to PACU (post-anesthesia care unit)
Oxycodone
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
intravenous paracetamol will be used (1.0 gram), up to 4 grams per day
ESP block
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.
Erector spinae plane block
Ultrasound-guided the erector spinae plane block with 0.375% ropivacaine, 0.4 mL per KG, up to 40 mL (maximum dose).
General anesthesia
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
All patients will receive a PCA pump with oxycodone (1 mg/mL, 5-minute interval) after transfer to PACU (post-anesthesia care unit)
Oxycodone
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
intravenous paracetamol will be used (1.0 gram), up to 4 grams per day
Sham block
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.
Sham block
Ultrasound-guided the erector spinae plane block with 0.9% saline, 0.4 mL per KG, up to 40 mL (maximum dose).
General anesthesia
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
All patients will receive a PCA pump with oxycodone (1 mg/mL, 5-minute interval) after transfer to PACU (post-anesthesia care unit)
Oxycodone
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
intravenous paracetamol will be used (1.0 gram), up to 4 grams per day
Interventions
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Erector spinae plane block
Ultrasound-guided the erector spinae plane block with 0.375% ropivacaine, 0.4 mL per KG, up to 40 mL (maximum dose).
Sham block
Ultrasound-guided the erector spinae plane block with 0.9% saline, 0.4 mL per KG, up to 40 mL (maximum dose).
General anesthesia
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
All patients will receive a PCA pump with oxycodone (1 mg/mL, 5-minute interval) after transfer to PACU (post-anesthesia care unit)
Oxycodone
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
intravenous paracetamol will be used (1.0 gram), up to 4 grams per day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* obtained consent
Exclusion Criteria
* the surgery of two breasts
* reoperation of the same breast
* previous participation in the study
* coagulopathy
* allergy to morphine and local anesthetics
* depression, antidepressant drugs treatment
* epilepsy
* usage of painkiller before surgery
* addiction to alcohol or recreational drugs
18 Years
80 Years
FEMALE
No
Sponsors
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Medical University of Lublin
OTHER
Responsible Party
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Michał Borys
associate professor
Principal Investigators
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Paweł Piwowarczyk, MD-PhD
Role: STUDY_CHAIR
Medical University of Lublin
Locations
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II Department of Anesthesia and Intensive Care, Medical University of Lublin
Lublin, , Poland
Countries
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References
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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.
Other Identifiers
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KE-0254/92/2018
Identifier Type: -
Identifier Source: org_study_id