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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group E | Active Comparator | Patients who receive general anesthesia after erector spina plane block |
|
| Group T | Active Comparator | Patients who receive general anesthesia after thoracic epidural block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erector spina plane block before general anaesthesia | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sympathetic block level evaluation with skin conductivity | Skin conductivity will be measured by galvanic skin response (GSR) | 45 minutes after block administration |
| Sympathetic block level evaluation with skin temperature | Skin temperature of bilateral thorax will be measured | 45 minutes after block administration |
| Sympathetic block level evaluation with hot cold test | Hot cold test of bilateral thorax will be measured | 45 minutes after block administration |
| Sympathetic block level evaluation by hemodynamic data | Peri-operative heart rate and mean arterial pressure will be recorded | 45 minutes after block administration |
| Sensorial block level evaluation | By pin-prick test | 45 minutes after block administration |
| Measure | Description | Time Frame |
|---|---|---|
| intraoperative hemodynamic data | Heart rate and mean arterial pressure | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gulay ERDOGAN KAYHAN, MD | Professor Doctor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eskisehir Osmangazi University | Eskişehir | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41691173 | Derived | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| Thoracic epidural block before general anaesthesia | Other | 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. |
|
| 24 hours after operation |
| Rescue analgesics consumption | Amount of remifentanil (microgram) | During the operation and 24 hours after operation |
| Rescue analgesics consumption | Amount of tramadol (milligram) | 24 hours after operation |
| D017437 |
| Skin and Connective Tissue Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |