Comparison of Erector Spina Plane Block and Thoracic Epidural Block

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Erector Spina Plane Block and Thoracic Epidural Block in Breast Surgery

Conditions
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Breast Neoplasms, Pain, Postoperative

Intervention / Treatment
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* Other: Erector spina plane block before general anaesthesia
* Other: Thoracic epidural block before general anaesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA(American Society of Anesthesiologist) physical classification I-III Patients undergoing unilateral mastectomies due to malignancy Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group E<br>Patients who receive general anesthesia after erector spina plane block | Other: Erector spina plane block before general anaesthesia<br>* 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.<br>|
| Active Comparator: Group T<br>Patients who receive general anesthesia after thoracic epidural block | Other: Thoracic epidural block before general anaesthesia<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |