Anesthesia, Local, Breast Cancer, Pain, Acute
Conditions
Keywords
erector spinae plane block, visual analog scale, quality of recovery, patient-controlled analgesia
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.
Interventions
PROCEDUREErector 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).
PROCEDURESham block
Ultrasound-guided the erector spinae plane block with 0.9% saline, 0.4 mL per KG, up to 40 mL (maximum dose).
PROCEDUREGeneral 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.
PROCEDUREPatient-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)
DRUGOxycodone
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.
DRUGparacetamol
intravenous paracetamol will be used (1.0 gram), up to 4 grams per day
Sponsors
Medical University of Lublin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, 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.
Intervention model description
Patients will be randomized 1:1:1
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Elective surgery of breast due to cancer * obtained consent
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Poland
Outcome results
None listed