Breast CancerPhase 4NCT04726878
ESP in Breast Surgery Due to Cancer
A Phase 4 study testing Erector spinae plane block, General anesthesia and Oxycodone in people with Breast Cancer and Pain, Acute, run by Medical University of Lublin at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer, Pain, Acute, Anesthesia, Local
- What is being tested?
- Erector spinae plane block, General anesthesia and Oxycodone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 sitePoland
- Study dates
- 1 Feb 2021to 17 Aug 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective surgery of breast due to cancer
- obtained consent
Who cannot join
- 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
Show all 10Show fewer
- depression, antidepressant drugs treatment
- epilepsy
- usage of painkiller before surgery
- addiction to alcohol or recreational drugs
Trial locations and contacts
1 site in 1 country.
Poland1 site
II Department of Anesthesia and Intensive Care, Medical University of Lublin
Lublin, 20-081
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer, Pain, Acute, Anesthesia, Local
- Being tested
- Erector spinae plane block, Sham block, General anesthesia, Patient-controlled analgesia, Oxycodone
- Keywords
- erector spinae plane block, visual analog scale, quality of recovery, patient-controlled analgesia
- Medical subject headings
- Breast Neoplasms, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane blockProcedure or surgery
Also called ESP block
Ultrasound-guided the erector spinae plane block with 0.375% ropivacaine, 0.4 mL per KG, up to 40 mL (maximum dose).
Sham blockProcedure or surgery
Ultrasound-guided the erector spinae plane block with 0.9% saline, 0.4 mL per KG, up to 40 mL (maximum dose).
General anesthesiaProcedure or surgery
Also called GA
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 analgesiaProcedure or surgery
Also called PCA
All patients will receive a PCA pump with oxycodone (1 mg/mL, 5-minute interval) after transfer to PACU (post-anesthesia care unit)
OxycodoneDrug
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.
paracetamolDrug
intravenous paracetamol will be used (1.0 gram), up to 4 grams per day
| Study group | Role | What they receive |
|---|---|---|
| Controlled | Placebo comparator | Standard care without regional block. General anesthesia. After the end of the surgery, the patient-controlled analgesia with oxycodone. Receives: 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. Receives: 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. Receives: Procedure: Sham block; Procedure: General anesthesia; Procedure: Patient-controlled analgesia; Drug: Oxycodone; Drug: paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before the hospital discharge
Secondary outcomes (3)
Patient-controlled analgesia (PCA)
All good and bad demands with PCA pump.
Measured: 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.
Measured: up to 24 hours after the surgery
Total oxycodone consumption
Consumption of oxycodone with PCA pump, loading, and additional doses.
Measured: up to 24 hours after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start1 Feb 2021
- Primary completion12 Aug 2021
- Study completion17 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized 1:1:1
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michał Borys, Medical University of Lublin
- Investigators
- Paweł Piwowarczyk, MD-PhD, Study chair, Medical University of Lublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726878
- Sponsor's protocol ID
- KE-0254/92/2018
- Status last verified
- May 2021
- First submitted
- 23 Jan 2021
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35836116
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Erector Spinae Plane Block in Patients Undergoing Breast Surgery Due to Cancer
- ClinicalTrials.gov ID
- NCT04726878
- Acronym / sponsor ID
- KE-0254/92/2018
- Conditions
- Breast Cancer, Pain, Acute, Anesthesia, Local
- Keywords
- erector spinae plane block, visual analog scale, quality of recovery, patient-controlled analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 12 Aug 2021 (actual)
- Study completion
- 17 Aug 2021 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Patients will be randomized 1:1:1
| Arm | Type | Receives |
|---|---|---|
| Controlled | Placebo comparator | Procedure: General anesthesia, Procedure: Patient-controlled analgesia, Drug: Oxycodone, Drug: paracetamolStandard care without regional block. General anesthesia. After the end of the surgery, the patient-controlled analgesia with oxycodone. |
| ESP block | Experimental | Procedure: Erector spinae plane block, Procedure: General anesthesia, Procedure: Patient-controlled analgesia, Drug: Oxycodone, Drug: paracetamolAfter 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. |
| Sham block | Sham comparator | Procedure: Sham block, Procedure: General anesthesia, Procedure: Patient-controlled analgesia, Drug: Oxycodone, Drug: paracetamolAfter 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective surgery of breast due to cancer
- obtained consent
Key exclusion criteria (10 listed)
- the lack of consent
- the surgery of two breasts
- reoperation of the same breast
- previous participation in the study
- coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector spinae plane blockAlso: ESP blockUltrasound-guided the erector spinae plane block with 0.375% ropivacaine, 0.4 mL per KG, up to 40 mL (maximum dose). | Procedure or surgery | ESP block |
| Sham blockUltrasound-guided the erector spinae plane block with 0.9% saline, 0.4 mL per KG, up to 40 mL (maximum dose). | Procedure or surgery | Sham block |
| General anesthesiaAlso: GAStandard 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. | Procedure or surgery | Controlled, ESP block, Sham block |
| Patient-controlled analgesiaAlso: PCAAll patients will receive a PCA pump with oxycodone (1 mg/mL, 5-minute interval) after transfer to PACU (post-anesthesia care unit) | Procedure or surgery | Controlled, ESP block, Sham block |
| OxycodoneIntravenous 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 | Controlled, ESP block, Sham block |
| paracetamolintravenous paracetamol will be used (1.0 gram), up to 4 grams per day | Drug | Controlled, ESP block, Sham block |
Primary outcome
Quality of recovery 40
Time frame: Before the hospital discharge
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.
3 secondary outcomes
Patient-controlled analgesia (PCA)
Time frame: 24 hours from the connection of the PCA pump in the post-anesthesia care unit.
Visual analog scale
Time frame: up to 24 hours after the surgery
Total oxycodone consumption
Time frame: up to 24 hours after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Derived from this study: PubMed 35836116Wiech 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.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paweł Piwowarczyk, MD-PhD study chair
Medical University of Lublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Erector spinae plane block, General anesthesia and Oxycodone in people with Breast Cancer and Pain, Acute, run by Medical University of Lublin at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of recovery 40 (time frame: Before the hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04726878, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.