Clinical trial NCT04726878: ESP in Breast Surgery Due to Cancer
Official title: Effectiveness of the Erector Spinae Plane Block in Patients Undergoing Breast Surgery Due to Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Pain, Acute
Anesthesia, Local
Keywords: erector spinae plane block
visual analog scale
quality of recovery
patient-controlled analgesia
Lead sponsor: Medical University of Lublin
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized 1:1:1
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of recovery 40
timeFrame: Before the hospital discharge
Secondary outcomes:
measure: Patient-controlled analgesia (PCA)
timeFrame: 24 hours from the connection of the PCA pump in the post-anesthesia care unit.
measure: Visual analog scale
timeFrame: up to 24 hours after the surgery
measure: Total oxycodone consumption
timeFrame: up to 24 hours after the surgery
Other outcomes:
Locations:
city: Lublin
country: Poland
facility: II Department of Anesthesia and Intensive Care, Medical University of Lublin
Study officials:
affiliation: Medical University of Lublin
name: Paweł Piwowarczyk, MD-PhD
role: STUDY_CHAIR
References:
citation: 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.