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ESP in Breast Surgery Due to Cancer

Primary Purpose

Breast Cancer, Pain, Acute, Anesthesia, Local

Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Erector spinae plane block
Sham block
General anesthesia
Patient-controlled analgesia
Oxycodone
paracetamol
Sponsored by
Medical University of Lublin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring erector spinae plane block, visual analog scale, quality of recovery, patient-controlled analgesia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • II Department of Anesthesia and Intensive Care, Medical University of Lublin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Sham Comparator

Arm Label

Controlled

ESP block

Sham block

Arm Description

Standard care without regional block. General anesthesia. After the end of the surgery, the patient-controlled analgesia with oxycodone.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Patient-controlled analgesia (PCA)
All good and bad demands with PCA pump.
Visual analog scale
Acute pain measured with VAS (visual analog scale). From 0 (no pain) to 100. More on the scale is worse.
Total oxycodone consumption
Consumption of oxycodone with PCA pump, loading, and additional doses.

Full Information

First Posted
January 23, 2021
Last Updated
November 8, 2021
Sponsor
Medical University of Lublin
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1. Study Identification

Unique Protocol Identification Number
NCT04726878
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
August 12, 2021 (Actual)
Study Completion Date
August 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Lublin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Pain, Acute, Anesthesia, Local
Keywords
erector spinae plane block, visual analog scale, quality of recovery, patient-controlled analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized 1:1:1
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Controlled
Arm Type
Placebo Comparator
Arm Description
Standard care without regional block. General anesthesia. After the end of the surgery, the patient-controlled analgesia with oxycodone.
Arm Title
ESP block
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham block
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Erector spinae plane block
Other Intervention Name(s)
ESP block
Intervention Description
Ultrasound-guided the erector spinae plane block with 0.375% ropivacaine, 0.4 mL per KG, up to 40 mL (maximum dose).
Intervention Type
Procedure
Intervention Name(s)
Sham block
Intervention Description
Ultrasound-guided the erector spinae plane block with 0.9% saline, 0.4 mL per KG, up to 40 mL (maximum dose).
Intervention Type
Procedure
Intervention Name(s)
General anesthesia
Other Intervention Name(s)
GA
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Patient-controlled analgesia
Other Intervention Name(s)
PCA
Intervention Description
All patients will receive a PCA pump with oxycodone (1 mg/mL, 5-minute interval) after transfer to PACU (post-anesthesia care unit)
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
paracetamol
Intervention Description
intravenous paracetamol will be used (1.0 gram), up to 4 grams per day
Primary Outcome Measure Information:
Title
Quality of recovery 40
Description
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.
Time Frame
Before the hospital discharge
Secondary Outcome Measure Information:
Title
Patient-controlled analgesia (PCA)
Description
All good and bad demands with PCA pump.
Time Frame
24 hours from the connection of the PCA pump in the post-anesthesia care unit.
Title
Visual analog scale
Description
Acute pain measured with VAS (visual analog scale). From 0 (no pain) to 100. More on the scale is worse.
Time Frame
up to 24 hours after the surgery
Title
Total oxycodone consumption
Description
Consumption of oxycodone with PCA pump, loading, and additional doses.
Time Frame
up to 24 hours after the surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paweł Piwowarczyk, MD-PhD
Organizational Affiliation
Medical University of Lublin
Official's Role
Study Chair
Facility Information:
Facility Name
II Department of Anesthesia and Intensive Care, Medical University of Lublin
City
Lublin
ZIP/Postal Code
20-081
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35836116
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.
Results Reference
derived

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ESP in Breast Surgery Due to Cancer

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