ESP in Breast Surgery Due to Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Anesthesia, Local; Pain, Acute
• Intervention / Treatment: Procedure: General anesthesia; Procedure: Patient-controlled analgesia; Drug: Oxycodone; Drug: paracetamol; Procedure: Erector spinae plane block; Procedure: Sham block

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Lublin, Poland, 20-081
    • II Department of Anesthesia and Intensive Care, Medical University of Lublin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Controlled; Standard care without regional block. General anesthesia. After the end of the surgery, the patient-controlled analgesia with oxycodone.	Procedure: 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.; Other Names: GA; Procedure: 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); Other Names: PCA; 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.; Drug: paracetamol; intravenous paracetamol will be used (1.0 gram), up to 4 grams per day
Experimental: ESP 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.	Procedure: 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.; Other Names: GA; Procedure: 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); Other Names: PCA; 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.; Drug: paracetamol; intravenous paracetamol will be used (1.0 gram), up to 4 grams per day; 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).; Other Names: ESP block
Sham Comparator: 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.	Procedure: 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.; Other Names: GA; Procedure: 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); Other Names: PCA; 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.; Drug: paracetamol; intravenous paracetamol will be used (1.0 gram), up to 4 grams per day; Procedure: Sham block; Ultrasound-guided the erector spinae plane block with 0.9% saline, 0.4 mL per KG, up to 40 mL (maximum dose).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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
Total oxycodone consumption	Consumption of oxycodone with PCA pump, loading, and additional doses.	up to 24 hours after the surgery

Collaborators and Investigators

• Sponsor: Medical University of Lublin
• Investigators: Study Chair: Paweł Piwowarczyk, MD-PhD, Medical University of Lublin

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): August 12, 2021
• Study Completion (Actual): August 17, 2021

Study Registration Dates

• First Submitted: January 23, 2021
• First Submitted That Met QC Criteria: January 23, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): November 9, 2021
• Last Update Submitted That Met QC Criteria: November 8, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: quality of recovery; patient-controlled analgesia; visual analog scale; erector spinae plane block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Analgesics, Opioid; Narcotics; Acetaminophen; Oxycodone
• Other Study ID Numbers: KE-0254/92/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No