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Erector Spinae Plane Block for Carotid Endarterectomy

NCT ID: NCT04224844

Last Updated: 2020-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-30

Study Completion Date

2021-02-28

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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Erector spinae plane block group (Group 1)

Patients will receive erector spinae plane block in addition to intravenous patient-controlled analgesia device containing tramadol.

Group Type ACTIVE_COMPARATOR

Erector spinae plane block

Intervention Type 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.

Control group (Group 2)

Control group will receive only intravenous patient-controlled analgesia device containing tramadol.

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type OTHER

Control group will receive only patient-controlled analgesia device containing tramadol. No block will be performed.

Interventions

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Erector spinae plane block

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.

Intervention Type OTHER

Control group

Control group will receive only patient-controlled analgesia device containing tramadol. No block will be performed.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Antalya Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ali Sait Kavakli, M.D.

Role: PRINCIPAL_INVESTIGATOR

Antalya Training and Research Hospital

Locations

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Antalya Training and Reseach Hospital

Antalya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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AntalyaTRH029

Identifier Type: -

Identifier Source: org_study_id