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
19 participants
INTERVENTIONAL
2018-02-07
2018-04-18
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ESP
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.
Erector Spinae Plane blockade
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.
Oxycodone
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
Each patient will generally anesthetized and endotracheal tube will be inserted
paracetamol
Paracetamol will be given i.v. every 6 hours.
PCA
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.
Oxycodone
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
Each patient will generally anesthetized and endotracheal tube will be inserted
paracetamol
Paracetamol will be given i.v. every 6 hours.
Interventions
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Erector Spinae Plane blockade
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.
Oxycodone
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
Each patient will generally anesthetized and endotracheal tube will be inserted
paracetamol
Paracetamol will be given i.v. every 6 hours.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* obtained consent
Exclusion Criteria
* depression, antidepressant drugs treatment
* epilepsy
* usage of painkiller before surgery
* addiction to alcohol or recreational drugs
* postoperative ventilation or ICU admission
18 Years
80 Years
ALL
No
Sponsors
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University of Rzeszow
OTHER
Medical University of Lublin
OTHER
Responsible Party
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Michał Borys
associate professor
Principal Investigators
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Mirosław Czuczwar, M.D., PhD
Role: STUDY_CHAIR
Medical University of Lublin
Locations
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Queen Jadwiga Hospital
Rzeszów, , Poland
Countries
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Other Identifiers
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KE-0254/26/2018
Identifier Type: -
Identifier Source: org_study_id