Erector Spinae Plane Block for Carotid Endarterectomy

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: Pain
• Intervention / Treatment: Other: Erector spinae plane block; Other: Control group

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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

Collaborators and Investigators

• Sponsor: Antalya Training and Research Hospital

Study record dates

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