ESP in Breast Surgery Due to Cancer

NCT04726878 | Completed Phase 4

• 1 other identifier: KE-0254/92/2018
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Pain, Acute; Anesthesia, Local

Keywords

erector spinae plane block; visual analog scale; quality of recovery; patient-controlled analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Patient-controlled analgesia (PCA)

  24 hours from the connection of the PCA pump in the post-anesthesia care unit.

• Visual analog scale

  up to 24 hours after the surgery

• Total oxycodone consumption

  up to 24 hours after the surgery

Study Arms (3)

Controlled

PLACEBO COMPARATOR

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

Procedure: General anesthesia; Procedure: Patient-controlled analgesia; Drug: Oxycodone; Drug: paracetamol

ESP block

EXPERIMENTAL

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: Erector spinae plane block; Procedure: General anesthesia; Procedure: Patient-controlled analgesia; Drug: Oxycodone; Drug: paracetamol

Sham block

SHAM COMPARATOR

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: Sham block; Procedure: General anesthesia; Procedure: Patient-controlled analgesia; Drug: Oxycodone; Drug: paracetamol

Interventions

Erector spinae plane block PROCEDURE

Ultrasound-guided the erector spinae plane block with 0.375% ropivacaine, 0.4 mL per KG, up to 40 mL (maximum dose).

Also known as: ESP block

ESP block

Sham block PROCEDURE

Ultrasound-guided the erector spinae plane block with 0.9% saline, 0.4 mL per KG, up to 40 mL (maximum dose).

Sham block

General anesthesia PROCEDURE

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.

Also known as: GA

Controlled; ESP block; Sham block

Patient-controlled analgesia PROCEDURE

All patients will receive a PCA pump with oxycodone (1 mg/mL, 5-minute interval) after transfer to PACU (post-anesthesia care unit)

Also known as: PCA

Controlled; ESP block; Sham block

Oxycodone DRUG

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.

Controlled; ESP block; Sham block

paracetamol DRUG

intravenous paracetamol will be used (1.0 gram), up to 4 grams per day

Controlled; ESP block; Sham block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective surgery of breast due to cancer
• obtained consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Lublin: lead

Study Sites (1)

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

Lublin, 20-081, Poland

Location

Related Publications (1)

• 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.

  PMID: 35836116 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Acute Pain

Interventions

Anesthesia, General; Analgesia, Patient-Controlled; Passive Cutaneous Anaphylaxis; Oxycodone; Acetaminophen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Analgesia; Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Paweł Piwowarczyk, MD-PhD

  Medical University of Lublin

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Model Details: Patients will be randomized 1:1:1

Study Record Dates

• First Submitted: January 23, 2021
• First Posted: January 27, 2021
• Study Start: February 1, 2021
• Primary Completion: August 12, 2021
• Study Completion: August 17, 2021
• Last Updated: November 9, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)