ESP in Breast Surgery Due to Cancer
- Conditions
- Pain, AcuteBreast CancerAnesthesia, Local
- Interventions
- Procedure: General anesthesiaProcedure: Erector spinae plane blockProcedure: Sham blockProcedure: Patient-controlled analgesia
- Registration Number
- NCT04726878
- Lead Sponsor
- Medical University of Lublin
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 75
- Elective surgery of breast due to cancer
- obtained consent
- the lack of consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Controlled paracetamol Standard care without regional block. General anesthesia. After the end of the surgery, the patient-controlled analgesia with oxycodone. Controlled Patient-controlled analgesia Standard care without regional block. General anesthesia. After the end of the surgery, the patient-controlled analgesia with oxycodone. Sham block Patient-controlled analgesia 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. ESP block Patient-controlled analgesia 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. Controlled General anesthesia Standard care without regional block. General anesthesia. After the end of the surgery, the patient-controlled analgesia with oxycodone. Sham block General anesthesia 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. ESP block Erector spinae plane 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. Sham block 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. ESP block General anesthesia 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. ESP block paracetamol 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 paracetamol 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. ESP block Oxycodone 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. Controlled Oxycodone Standard care without regional block. General anesthesia. After the end of the surgery, the patient-controlled analgesia with oxycodone. Sham block Oxycodone 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.
- Primary Outcome Measures
Name Time Method Quality of recovery 40 Before the hospital discharge 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.
- Secondary Outcome Measures
Name Time Method Patient-controlled analgesia (PCA) 24 hours from the connection of the PCA pump in the post-anesthesia care unit. All good and bad demands with PCA pump.
Visual analog scale up to 24 hours after the surgery Acute pain measured with VAS (visual analog scale). From 0 (no pain) to 100. More on the scale is worse.
Total oxycodone consumption up to 24 hours after the surgery Consumption of oxycodone with PCA pump, loading, and additional doses.
Trial Locations
- Locations (1)
II Department of Anesthesia and Intensive Care, Medical University of Lublin
🇵🇱Lublin, Poland
II Department of Anesthesia and Intensive Care, Medical University of Lublin🇵🇱Lublin, Poland