Breast Cancer SurgeryNCT06758765
Erector Spinae Plane Block vs. PECS I-II Blocks After Breast-conserving Surgery
A study testing Erector Spinae Plane Block and Pectoral Nerve Block in people with Breast Cancer Surgery and Breast Conserving Surgery, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this study is to compare the analgesic effects of ESPB and PECS II blocks in patients undergoing BCS. The main question it aims to answer is: Whether these two different block procedures will create a difference in postoperative pain scores. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer Surgery, Breast Conserving Surgery, Erector Spinae Plane Block
- What is being tested?
- Erector Spinae Plane Block and Pectoral Nerve Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 30 Nov 2022
- Phase
- Interventional
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female
- age between 18-70
- underwent breast conserving surgery
Who cannot join
- patients with coagulopathy
- known local anesthetic allergy
- abnormal liver function tests
- infection at the planned injection site
- chronic usage of analgesics
- under the age of 18
Show all 9Show fewer
- over the age of 70
- ASA (American Society of Anesthesiologists) IV and higher risk classes
- limited cooperation for Visual Analog Scale (VAS) follow-ups
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Basaksehir Cam ve Sakura City Hospital
Istanbul, 34480
About this study
Official title: Comparison of the Effects of the Erector Spinae Plane Block and PECS I-II Blocks on Postoperative Opioid Consumption and Pain Scores of Patients After Breast-conserving Surgery: A Prospective Randomized Controlled Trial
The goal of this study is to compare the analgesic effects of ESPB and PECS II blocks in patients undergoing BCS. The main question it aims to answer is:
- Whether these two different block procedures will create a difference in postoperative pain scores.
- Comparison of total opioid consumption during the 24-hour postoperative period.
Our study included patients who were female, who were going to undergo elective breast-conserving surgery between March 2022 and August 2022.
Read the detailed description
The patients to be included in our study were divided into two groups as ESPB group or PECS II group by an anesthesia assistant independent of the study using a computer-based randomization program one day before the operation. All patients were informed about the block in the preoperative period, the use of the patient-controlled analgesia device to be used after the operation, and Visual Analog Scale (VAS) assessment. (Patients were asked to indicate their pain on a scale where 0 represented "no pain" and 10 represented "unbearable pain.)
On the day of the operation, group envelopes were placed in the patient files to indicate the groups in sealed envelopes. The appropriate anesthesia method was applied to the patient according to the group written on the patient's envelope by the relevant anesthesiologist on duty in the study. Our study was conducted as a randomized controlled and prospective study.
VAS scores at 0, 15, 30, 60 minutes postoperatively recorded for the primer output of the study. For the secondary outputs the total amount of analgesic used was recorded from the records of the PCA device. All patients' demographic data, intraoperative hemodynamic data, anesthesia duration, surgical duration and hospital stay, VAS at 4, 6, 12, 24 hours in the service follow-up, rescue analgesic requirements and numbers, nausea-vomiting and developing complications were evaluated and recorded. The evaluations were made by the anesthesiologist who was blind to the groups.
- Conditions
- Breast Cancer Surgery, Breast Conserving Surgery, Erector Spinae Plane Block, Pectoral Nerve (PECS) Block, Visual Analog Scale, Opioid Consumption
- Being tested
- Erector Spinae Plane Block, Pectoral Nerve Block
- Keywords
- erector spinae plane block, pectoral nerve (PECS) block, postoperative pain, breast conserving surgery
- Medical subject headings
- Bites and Stings, Pain, Postoperative
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
ESPB was applied to the patients in a sitting position. A high-frequency linear probe was used. Under sterile conditions, the USG probe was placed longitudinally approximately 2 cm lateral to the T4 spinous process. Skin, subcutaneous fat tissue, m. trapezius, rhomboid muscles, erector group muscles, transverse process, intercostal muscles, pleura and lung movements were visualized from superficial to deep structures. 1 ml of 2% lidocaine was injected into the estimated needle entry area. Then, with the block needle the m. trapezius, mm. rhomboidei and erector spinae muscles were passed in order with the in-plane method and the needle was brought into contact with the transverse process. Fascial separation was confirmed with 1-2 ml of saline solution and the block was performed by injecting 20 ml of 0.375% bupivacaine. The distribution of the drug was confirmed by observing it with USG.
Pectoral Nerve BlockProcedure or surgery
The PECSI and PECSII blocks were applied concurrently.
In patients who will undergo PECS II, sterile conditions were prepared with the arm on the side to be operated on in the supine position and 90 degrees of abduction. The lateral and pectoral branches of the thoracoacromial artery were visualized between the PM and Pm muscles at the level of the 4th rib under USG guidance. The blocking needle was directed between the PM and Pm muscles for PECS I, 1-2 ml of saline was injected to verify fascial spread, and 10 ml of 0.375% bupivacaine was applied. Afterwards, fascial spread was confirmed by injecting 1-2 ml of saline between the pectoralis minor muscle and the serratur anterior muscle, and PECS II was performed by injecting 10 ml of 0.375% concentration bupivacaine. The distribution of the drug was confirmed by observing it with USG.
| Study group | Role | What they receive |
|---|---|---|
| ESP group | Experimental | The group that received erector spinae plane block Receives: Procedure: Erector Spinae Plane Block |
| PECS group | Experimental | The group that received PECSI-II blocks Receives: Procedure: Pectoral Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early postoperative Visual Analog Scale (VAS) scores
The postoperative pain level that evaluated with evaluated with VAS at 0, 15, 30 and 60 minutes.
Patients were asked to indicate their pain on a scale where 0 represented "no pain" and 10 represented "unbearable pain".
Measured: First hour after surgery
Secondary outcomes (3)
Additional opioid analgesic requirement in the postanesthesia care unit
Patients who scored 4 and above in the pain score were administered 10 mg meperidine.
Measured: First hour after surgery
Total opioid consumption after discharging from postanesthesia care unit
The PCA device, which was applied to the patients at the 60th minute postoperatively, was left for patient use until the 24th hour postoperatively.
Measured: Between 1-24 hours after surgery
Visual Analog Scale (VAS) during 24 hours follow-up after surgery
VAS values after discharge from the postanesthesia care unit
Patients were asked to indicate their pain on a scale where 0 represented "no pain" and 10 represented "unbearable pain".
Measured: 1th, 4th, 6th, 12th, and 24th hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start1 Mar 2022
- Primary completion31 Aug 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer SurgeryStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taner Abdullah, Istanbul Saglik Bilimleri University
- Investigators
- Funda Gümüş Özcan, Prof, Study chair, Basaksehir Cam ve Sakura State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758765
- Sponsor's protocol ID
- 2022.02.44
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bakeer A, Abdallah NM. Erector Spinae Plane Block Versus PECS Block Type II for Breast Surgery: A Randomized Controlled Trial. Anesth Pain Med. 2022 Apr 25;12(2):e122917. doi: 10.5812/aapm-122917. eCollection 2022 Apr.
PubMed 35991781Hong B, Bang S, Oh C, Park E, Park S. Comparison of PECS II and erector spinae plane block for postoperative analgesia following modified radical mastectomy: Bayesian network meta-analysis using a control group. J Anesth. 2021 Oct;35(5):723-733. doi: 10.1007/s00540-021-02923-x. Epub 2021 Mar 30.
PubMed 33786681Altiparmak B, Korkmaz Toker M, Uysal AI, Turan M, Gumus Demirbilek S. Comparison of the effects of modified pectoral nerve block and erector spinae plane block on postoperative opioid consumption and pain scores of patients after radical mastectomy surgery: A prospective, randomized, controlled trial. J Clin Anesth. 2019 May;54:61-65. doi: 10.1016/j.jclinane.2018.10.040. Epub 2018 Nov 3.
PubMed 30396100
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of the Erector Spinae Plane Block and PECS I-II Blocks on Postoperative Opioid Consumption and Pain Scores of Patients After Breast-conserving Surgery: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06758765
- Acronym / sponsor ID
- 2022.02.44
- Conditions
- Breast Cancer Surgery, Breast Conserving Surgery, Erector Spinae Plane Block, Pectoral Nerve (PECS) Block, Visual Analog Scale, Opioid Consumption
- Keywords
- erector spinae plane block, pectoral nerve (PECS) block, postoperative pain, breast conserving surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 6 Jan 2025 (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.
The goal of this study is to compare the analgesic effects of ESPB and PECS II blocks in patients undergoing BCS. The main question it aims to answer is:
- Whether these two different block procedures will create a difference in postoperative pain scores.
- Comparison of total opioid consumption during the 24-hour postoperative period.
Our study included patients who were female, who were going to undergo elective breast-conserving surgery between March 2022 and August 2022.
Detailed description
The patients to be included in our study were divided into two groups as ESPB group or PECS II group by an anesthesia assistant independent of the study using a computer-based randomization program one day before the operation. All patients were informed about the block in the preoperative period, the use of the patient-controlled analgesia device to be used after the operation, and Visual Analog Scale (VAS) assessment. (Patients were asked to indicate their pain on a scale where 0 represented "no pain" and 10 represented "unbearable pain.)
On the day of the operation, group envelopes were placed in the patient files to indicate the groups in sealed envelopes. The appropriate anesthesia method was applied to the patient according to the group written on the patient's envelope by the relevant anesthesiologist on duty in the study. Our study was conducted as a randomized controlled and prospective study.
VAS scores at 0, 15, 30, 60 minutes postoperatively recorded for the primer output of the study. For the secondary outputs the total amount of analgesic used was recorded from the records of the PCA device. All patients' demographic data, intraoperative hemodynamic data, anesthesia duration, surgical duration and hospital stay, VAS at 4, 6, 12, 24 hours in the service follow-up, rescue analgesic requirements and numbers, nausea-vomiting and developing complications were evaluated and recorded. The evaluations were made by the anesthesiologist who was blind to the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESP group | Experimental | Procedure: Erector Spinae Plane BlockThe group that received erector spinae plane block |
| PECS group | Experimental | Procedure: Pectoral Nerve BlockThe group that received PECSI-II blocks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- female
- age between 18-70
- underwent breast conserving surgery
Key exclusion criteria (9 listed)
- patients with coagulopathy
- known local anesthetic allergy
- abnormal liver function tests
- infection at the planned injection site
- chronic usage of analgesics
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 BlockESPB was applied to the patients in a sitting position. A high-frequency linear probe was used. Under sterile conditions, the USG probe was placed longitudinally approximately 2 cm lateral to the T4 spinous process. Skin, subcutaneous fat tissue, m. trapezius, rhomboid muscles, erector group muscles, transverse process, intercostal muscles, pleura and lung movements were visualized from superficial to deep structures. 1 ml of 2% lidocaine was injected into the estimated needle entry area. Then, with the block needle the m. trapezius, mm. rhomboidei and erector spinae muscles were passed in order with the in-plane method and the needle was brought into contact with the transverse process. Fascial separation was confirmed with 1-2 ml of saline solution and the block was performed by injecting 20 ml of 0.375% bupivacaine. The distribution of the drug was confirmed by observing it with USG. | Procedure or surgery | ESP group |
| Pectoral Nerve BlockThe PECSI and PECSII blocks were applied concurrently. In patients who will undergo PECS II, sterile conditions were prepared with the arm on the side to be operated on in the supine position and 90 degrees of abduction. The lateral and pectoral branches of the thoracoacromial artery were visualized between the PM and Pm muscles at the level of the 4th rib under USG guidance. The blocking needle was directed between the PM and Pm muscles for PECS I, 1-2 ml of saline was injected to verify fascial spread, and 10 ml of 0.375% bupivacaine was applied. Afterwards, fascial spread was confirmed by injecting 1-2 ml of saline between the pectoralis minor muscle and the serratur anterior muscle, and PECS II was performed by injecting 10 ml of 0.375% concentration bupivacaine. The distribution of the drug was confirmed by observing it with USG. | Procedure or surgery | PECS group |
Primary outcome
Early postoperative Visual Analog Scale (VAS) scores
Time frame: First hour after surgery
The postoperative pain level that evaluated with evaluated with VAS at 0, 15, 30 and 60 minutes. Patients were asked to indicate their pain on a scale where 0 represented "no pain" and 10 represented "unbearable pain".
3 secondary outcomes
Additional opioid analgesic requirement in the postanesthesia care unit
Time frame: First hour after surgery
Total opioid consumption after discharging from postanesthesia care unit
Time frame: Between 1-24 hours after surgery
Visual Analog Scale (VAS) during 24 hours follow-up after surgery
Time frame: 1th, 4th, 6th, 12th, and 24th hours postoperatively
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 6 Jan 2025.
- Results publication: PubMed 35991781Bakeer A, Abdallah NM. Erector Spinae Plane Block Versus PECS Block Type II for Breast Surgery: A Randomized Controlled Trial. Anesth Pain Med. 2022 Apr 25;12(2):e122917. doi: 10.5812/aapm-122917. eCollection 2022 Apr.
- Results publication: PubMed 33786681Hong B, Bang S, Oh C, Park E, Park S. Comparison of PECS II and erector spinae plane block for postoperative analgesia following modified radical mastectomy: Bayesian network meta-analysis using a control group. J Anesth. 2021 Oct;35(5):723-733. doi: 10.1007/s00540-021-02923-x. Epub 2021 Mar 30.
- Results publication: PubMed 30396100Altiparmak B, Korkmaz Toker M, Uysal AI, Turan M, Gumus Demirbilek S. Comparison of the effects of modified pectoral nerve block and erector spinae plane block on postoperative opioid consumption and pain scores of patients after radical mastectomy surgery: A prospective, randomized, controlled trial. J Clin Anesth. 2019 May;54:61-65. doi: 10.1016/j.jclinane.2018.10.040. Epub 2018 Nov 3.
- Individual participant dataSharing planned: Undecided
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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.
Funda Gümüş Özcan, Prof study chair
Basaksehir Cam ve Sakura State Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plane Block and Pectoral Nerve Block in people with Breast Cancer Surgery and Breast Conserving Surgery, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
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 3 inclusion and 9 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 6 Jan 2025. 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 Turkey (Türkiye). 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Early postoperative Visual Analog Scale (VAS) scores (time frame: First hour after surgery). 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 NCT06758765, which also lists 3 linked publications.
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 6 Jan 2025.