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not recruiting, awaiting for changes in IRB
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erector spinae plane block group (Group 1) | Active Comparator | Patients will receive erector spinae plane block in addition to intravenous patient-controlled analgesia device containing tramadol. |
|
| Control group (Group 2) | Active Comparator | Control group will receive only intravenous patient-controlled analgesia device containing tramadol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erector spinae plane block | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ali Sait Kavakli, M.D. | Antalya Training and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antalya Training and Reseach Hospital | Antalya | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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|
| Control group | Other | Control group will receive only patient-controlled analgesia device containing tramadol. No block will be performed. |
|
| D008722 | Methods |