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Erector Spinae Plane Block for Carotid Endarterectomy

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

Status
Suspended
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04224844
Enrollment
34
Registered
2020-01-13
Start date
2020-09-30
Completion date
2021-02-28
Last updated
2020-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Brief summary

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

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.

Interventions

OTHERErector 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.

OTHERControl group

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

Sponsors

Antalya Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
24 hours tramadol consumption24 hoursTotal tramadol consumption in milligrams at 24 hrs will be scored.
6 hours tramadol consumption6 hoursTotal tramadol consumption in milligrams at 6 hrs will be scored.
12 hours tramadol consumption12 hoursTotal tramadol consumption in milligrams at 12 hrs will be scored.
Assesment of postoperative analgesia24 hoursPost operative pain scores will be assessed using a numerical rating scala (NRS) (from 0=no pain, to10= worst pain imaginable) at 24 hrs.

Secondary

MeasureTime frameDescription
Amount of use of intraoperative local anesthetic.1 hourIntraoperative 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026