Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04726878
Other study ID # KE-0254/92/2018
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Withdrawn NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Completed NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A