ESP in Breast Surgery Due to Cancer

Breast Cancer Clinical Trial

Official title:

Effectiveness of the Erector Spinae Plane Block in Patients Undergoing Breast Surgery Due to Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04726878
• Other study ID #: KE-0254/92/2018
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2021
• Est. completion date: August 17, 2021

Study information

• Verified date: May 2021
• Source: Medical University of Lublin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: August 17, 2021
• Est. primary completion date: August 12, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Anesthesia, Local
• Breast Cancer
• Pain, Acute

Intervention

Procedure:
• Erector 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).
• Sham block
Ultrasound-guided the erector spinae plane block with 0.9% saline, 0.4 mL per KG, up to 40 mL (maximum dose).
• General 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.
• Patient-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)

Drug:
• Oxycodone
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.
• paracetamol
intravenous paracetamol will be used (1.0 gram), up to 4 grams per day

Locations

Country	Name	City	State
Poland	II Department of Anesthesia and Intensive Care, Medical University of Lublin	Lublin

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Lublin

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of recovery 40	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.	Before the hospital discharge
Secondary	Patient-controlled analgesia (PCA)	All good and bad demands with PCA pump.	24 hours from the connection of the PCA pump in the post-anesthesia care unit.
Secondary	Visual analog scale	Acute pain measured with VAS (visual analog scale). From 0 (no pain) to 100. More on the scale is worse.	up to 24 hours after the surgery
Secondary	Total oxycodone consumption	Consumption of oxycodone with PCA pump, loading, and additional doses.	up to 24 hours after the surgery