Erector Spinae Plane Block for Carotid Endarterectomy

Study Overview
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Brief Summary
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The purpose of this study is to test the hypothesis that erector spinae plane block will decrease intraoperative local anesthetic and postoperative analgesic consumption in patients undergoing carotid endarterectomy.

Detailed Description
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Patients who decided to participate in the study will be randomized into 2 groups: Erector Spinae Plane Block Group (Group E) and Control Group (Group C). Intraoperative local anesthetic consumption, postoperative tramadol consumption, intraoperative and pain scores, hemodynamic parameters and patient satisfaction will be recorded.

Official Title
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Ultrasound-Guided Spinae Plane Block for Perioperative Pain Control in Carotid Endarterectomy.

Conditions
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Pain

Intervention / Treatment
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* Other: Erector spinae plane block
* Other: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing carotid endarterectomy American Society of Anesthesiologists class 2 to 3 Ability to consent Exclusion Criteria: inability to communicate not understand the aim and objectives of the study not provide informed written consent contraindications for the block (local infection, coagulation disorders) hypersensitivity to the local anesthetics refusal of regional anesthesia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Erector spinae plane block group (Group 1)<br>Patients will receive erector spinae plane block in addition to intravenous patient-controlled analgesia device containing tramadol. | Other: Erector spinae plane block<br>* The block will be performed before the surgery. The spinous process of T2 or T3 wil be identified by an ultrasound guide, with the probe positioned longitudinally. A block needle will be inserted in the caudo-cephal direction. After the injection site is confirmed by 3 ml of physiological solution and correct position of the needle tip is confirmed, bupivacaine will be injected. The patients assigned to this group will also receive an intravenous patient-controlled analgesia device containing tramadol postoperatively.<br>|
| Active Comparator: Control group (Group 2)<br>Control group will receive only intravenous patient-controlled analgesia device containing tramadol. | Other: Control group<br>* Control group will receive only patient-controlled analgesia device containing tramadol. No block will be performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hours tramadol consumption | Total tramadol consumption in milligrams at 24 hrs will be scored. | 24 hours | 
| 6 hours tramadol consumption | Total tramadol consumption in milligrams at 6 hrs will be scored. | 6 hours | 
| 12 hours tramadol consumption | Total tramadol consumption in milligrams at 12 hrs will be scored. | 12 hours | 
| Assesment of postoperative analgesia | Post operative pain scores will be assessed using a numerical rating scala (NRS) (from 0=no pain, to10= worst pain imaginable) at 24 hrs. | 24 hours | 
| Assesment of postoperative analgesia | Post operative pain scores will be assessed using a numerical rating scala (NRS) (from 0=no pain, to10= worst pain imaginable) at 6 hours. | 6 hours | 
| Assesment of postoperative analgesia | Post operative pain scores will be assessed using a numerical rating scala (NRS) (from 0=no pain, to10= worst pain imaginable) at 12 hours. | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of use of intraoperative local anesthetic. | Intraoperative pain will be assessed using a visual analog scale (VAS) (from 0 = no pain to 10 = maximum possible pain). When intraoperative VAS is >3, supplemental local anesthetic will be administered to the surgical area by the surgeon. Amount of total local anesthetic in milligrams will be recorded at the end of the surgery. | 1 hour |