ESP in Breast Surgery Due to Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 75
Summary
- Conditions
- Anesthesia Local
- Breast Cancer
- Pain Acute
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Patients will be randomized 1:1:1Masking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: 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.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Only males
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 lary...
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.
Tracking Information
- NCT #
- NCT04726878
- Collaborators
- Not Provided
- Investigators
- Study Chair: Pawe? Piwowarczyk, MD-PhD Medical University of Lublin
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