Erector Spinae Plane Block for Carotid Endarterectomy

April 29, 2020 updated by: Antalya Training and Research Hospital

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Antalya, Turkey
        • Antalya Training and Reseach Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Erector spinae plane block group (Group 1)
Patients will receive erector spinae plane block in addition to intravenous patient-controlled analgesia device containing tramadol.
Other: 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.
ACTIVE_COMPARATOR: Control group (Group 2)
Control group will receive only intravenous patient-controlled analgesia device containing tramadol.
Other: Control group
Control group will receive only patient-controlled analgesia device containing tramadol. No block will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24 hours tramadol consumption
Time Frame: 24 hours
Total tramadol consumption in milligrams at 24 hrs will be scored.
24 hours
6 hours tramadol consumption
Time Frame: 6 hours
Total tramadol consumption in milligrams at 6 hrs will be scored.
6 hours
12 hours tramadol consumption
Time Frame: 12 hours
Total tramadol consumption in milligrams at 12 hrs will be scored.
12 hours
Assesment of postoperative analgesia
Time Frame: 24 hours
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
Time Frame: 6 hours
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
Time Frame: 12 hours
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.
Time Frame: 1 hour
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antalya Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2020

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

February 1, 2021

Study Registration Dates

First Submitted

January 7, 2020

First Submitted That Met QC Criteria

January 8, 2020

First Posted (ACTUAL)

January 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 30, 2020

Last Update Submitted That Met QC Criteria

April 29, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • AntalyaTRH029

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe