Breast NeoplasmsNCT04702061
Comparison of Erector Spina Plane Block and Thoracic Epidural Block
A study testing Erector spina plane block before general anaesthesia and Thoracic epidural block before general anaesthesia in people with Breast Neoplasms and Pain, Postoperative, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this randomised controlled and double-blind study, is to compare the effects of erector spinae plane (ESP) and thoracic epidural (TEA) blocks on peri-operative hemodynamics and analgesia in patients undergoing unilateral mastectomies due to malignancy. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Neoplasms, Pain, Postoperative
- What is being tested?
- Erector spina plane block before general anaesthesia and Thoracic epidural block before general anaesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Jan 2021to 31 Mar 2021
- 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
- ASA(American Society of Anesthesiologist) physical classification I-III
- Patients undergoing unilateral mastectomies due to malignancy
Who cannot join
- Active infection at the intervention site
- History of coagulopathy or anticoagulant use (less time has passed before peripheral and central blocks)
- Major cardiac, pulmonary, renal and neurological diseases
- Autonomic neuropathy or use of drugs that affect autonomic function
- Patients with type 1 diabetes or insulin dependent type 2 diabetes over 10 years
- Allergic to local anesthetics;
- Patients who are uncooperative or have psychiatric problems
- Morbidly obese (body mass index > 35 kg/m2)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Erector Spina Plane Block and Thoracic Epidural Block in Breast Surgery
The aim of this randomised controlled and double-blind study, is to compare the effects of erector spinae plane (ESP) and thoracic epidural (TEA) blocks on peri-operative hemodynamics and analgesia in patients undergoing unilateral mastectomies due to malignancy.
Read the detailed description
Patients will be randomised into two groups as Group E (those who received general anesthesia after the erector spina plan block) and Group T (those who received general anesthesia after thoracic epidural block).
After the block skin conductivity (galvanic skin response - GSR), body temperature changes, sympathetic and sensory block levels, peri-operative hemodynamic data, postoperative pain scores and analgesic consumption will be recorded.
- Conditions
- Breast Neoplasms, Pain, Postoperative
- Being tested
- Erector spina plane block before general anaesthesia, Thoracic epidural block before general anaesthesia
- Medical subject headings
- Breast Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spina plane block before general anaesthesiaOther
After skin infiltration with 2 ml of 2% lidocaine, an 18 G tuohy needle will be directed between the erector spina muscle and the transverse process of the T4 vertebra using the in-plane technique. The location of the needle will be confirmed by hydrodissection with saline after touching the transverse process. After the plan open, 5 ml of 2% lidocaine, 10 ml of 0.5% bupivacaine and 10 ml of saline, including hydrodissection, will be given in a total amount of 25 ml. Then a 20-G epidural catheter will be inserted 3-4 cm and fixed.
Thoracic epidural block before general anaesthesiaOther
After skin infiltration with 2 ml of 2% lidocaine, an 18 G tuohy needle will be entered through the T4-5 interspinous space (median or paramedian approach). After reaching the thoracic epidural area by loss of resistance method, the epidural catheter will be advanced and fixed to remain 3-4 cm in the epidural area. Following the test dose (2 ml of 2% lidocaine), 3 ml of 2% lidocaine, 5 ml of 0.5% bupivacaine and 5 ml of saline will be administered intermittently in a total volume of 15 ml.
| Study group | Role | What they receive |
|---|---|---|
| Group E | Active comparator | Patients who receive general anesthesia after erector spina plane block Receives: Other: Erector spina plane block before general anaesthesia |
| Group T | Active comparator | Patients who receive general anesthesia after thoracic epidural block Receives: Other: Thoracic epidural block before general anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sympathetic block level evaluation with skin conductivity
Skin conductivity will be measured by galvanic skin response (GSR)
Measured: 45 minutes after block administration
Sympathetic block level evaluation with skin temperature
Skin temperature of bilateral thorax will be measured
Measured: 45 minutes after block administration
Sympathetic block level evaluation with hot cold test
Hot cold test of bilateral thorax will be measured
Measured: 45 minutes after block administration
Sympathetic block level evaluation by hemodynamic data
Peri-operative heart rate and mean arterial pressure will be recorded
Measured: 45 minutes after block administration
Sensorial block level evaluation
By pin-prick test
Measured: 45 minutes after block administration
Secondary outcomes (4)
intraoperative hemodynamic data
Heart rate and mean arterial pressure
Measured: During the operation
Postoperative pain scores
Pain score will be measured with visual analog scale (0-no pain; 10-worst pain) during movement and rest.
Measured: 24 hours after operation
Rescue analgesics consumption
Amount of remifentanil (microgram)
Measured: During the operation and 24 hours after operation
Rescue analgesics consumption
Amount of tramadol (milligram)
Measured: 24 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start11 Jan 2021
- Primary completion31 Mar 2021
- Study completion31 Mar 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 NeoplasmsStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulay ERDOGAN KAYHAN, Inonu University
- Investigators
- Gulay ERDOGAN KAYHAN, MD, Principal investigator, Professor Doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702061
- Sponsor's protocol ID
- Esogu Anesthesia
- Status last verified
- Apr 2021
- First submitted
- 24 Dec 2020
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kurada G, Erdogan Kayhan G, Sanal S, Onay M, Gulec MS. Comparison of sympathetic block and hemodynamic effects of erector spinae plane block and thoracic epidural analgesia in breast surgery: a randomised controlled trial. BMC Anesthesiol. 2026 Feb 14;26(1):184. doi: 10.1186/s12871-026-03694-2.
PubMed 41691173
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Erector Spina Plane Block and Thoracic Epidural Block in Breast Surgery
- ClinicalTrials.gov ID
- NCT04702061
- Acronym / sponsor ID
- Esogu Anesthesia
- Conditions
- Breast Neoplasms, Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 8 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.
The aim of this randomised controlled and double-blind study, is to compare the effects of erector spinae plane (ESP) and thoracic epidural (TEA) blocks on peri-operative hemodynamics and analgesia in patients undergoing unilateral mastectomies due to malignancy.
Detailed description
Patients will be randomised into two groups as Group E (those who received general anesthesia after the erector spina plan block) and Group T (those who received general anesthesia after thoracic epidural block).
After the block skin conductivity (galvanic skin response - GSR), body temperature changes, sympathetic and sensory block levels, peri-operative hemodynamic data, postoperative pain scores and analgesic consumption will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group E | Active comparator | Other: Erector spina plane block before general anaesthesiaPatients who receive general anesthesia after erector spina plane block |
| Group T | Active comparator | Other: Thoracic epidural block before general anaesthesiaPatients who receive general anesthesia after thoracic epidural block |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA(American Society of Anesthesiologist) physical classification I-III
- Patients undergoing unilateral mastectomies due to malignancy
Key exclusion criteria (8 listed)
- Active infection at the intervention site
- History of coagulopathy or anticoagulant use (less time has passed before peripheral and central blocks)
- Major cardiac, pulmonary, renal and neurological diseases
- Autonomic neuropathy or use of drugs that affect autonomic function
- Patients with type 1 diabetes or insulin dependent type 2 diabetes over 10 years
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 spina plane block before general anaesthesiaAfter skin infiltration with 2 ml of 2% lidocaine, an 18 G tuohy needle will be directed between the erector spina muscle and the transverse process of the T4 vertebra using the in-plane technique. The location of the needle will be confirmed by hydrodissection with saline after touching the transverse process. After the plan open, 5 ml of 2% lidocaine, 10 ml of 0.5% bupivacaine and 10 ml of saline, including hydrodissection, will be given in a total amount of 25 ml. Then a 20-G epidural catheter will be inserted 3-4 cm and fixed. | Other | Group E |
| Thoracic epidural block before general anaesthesiaAfter skin infiltration with 2 ml of 2% lidocaine, an 18 G tuohy needle will be entered through the T4-5 interspinous space (median or paramedian approach). After reaching the thoracic epidural area by loss of resistance method, the epidural catheter will be advanced and fixed to remain 3-4 cm in the epidural area. Following the test dose (2 ml of 2% lidocaine), 3 ml of 2% lidocaine, 5 ml of 0.5% bupivacaine and 5 ml of saline will be administered intermittently in a total volume of 15 ml. | Other | Group T |
Primary outcome
Sympathetic block level evaluation with skin conductivity
Time frame: 45 minutes after block administration
Skin conductivity will be measured by galvanic skin response (GSR)
Sympathetic block level evaluation with skin temperature
Time frame: 45 minutes after block administration
Skin temperature of bilateral thorax will be measured
Sympathetic block level evaluation with hot cold test
Time frame: 45 minutes after block administration
Hot cold test of bilateral thorax will be measured
Sympathetic block level evaluation by hemodynamic data
Time frame: 45 minutes after block administration
Peri-operative heart rate and mean arterial pressure will be recorded
Sensorial block level evaluation
Time frame: 45 minutes after block administration
By pin-prick test
4 secondary outcomes
intraoperative hemodynamic data
Time frame: During the operation
Postoperative pain scores
Time frame: 24 hours after operation
Rescue analgesics consumption
Time frame: During the operation and 24 hours after operation
Rescue analgesics consumption
Time frame: 24 hours after operation
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 20 Apr 2021.
- Derived from this study: PubMed 41691173Kurada G, Erdogan Kayhan G, Sanal S, Onay M, Gulec MS. Comparison of sympathetic block and hemodynamic effects of erector spinae plane block and thoracic epidural analgesia in breast surgery: a randomised controlled trial. BMC Anesthesiol. 2026 Feb 14;26(1):184. doi: 10.1186/s12871-026-03694-2.
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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.
Gulay ERDOGAN KAYHAN, MD principal investigator
Professor Doctor
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 spina plane block before general anaesthesia and Thoracic epidural block before general anaesthesia in people with Breast Neoplasms and Pain, Postoperative, run by Inonu 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 2 inclusion and 8 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 20 Apr 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 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?
Sympathetic block level evaluation with skin conductivity (time frame: 45 minutes after block administration). The study lists 5 primary outcomes in all. 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 NCT04702061, 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 20 Apr 2021.