Erector Spinae Plane Block for Carotid Endarterectomy

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04224844
• Other study ID #: AntalyaTRH029
• Status: Suspended
• Phase: N/A
• Start date: September 2020
• Est. completion date: February 2021

Study information

• Verified date: April 2020
• Source: Antalya Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 34
• Est. completion date: February 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
Turkey	Antalya Training and Reseach Hospital	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hours tramadol consumption	Total tramadol consumption in milligrams at 24 hrs will be scored.	24 hours
Primary	6 hours tramadol consumption	Total tramadol consumption in milligrams at 6 hrs will be scored.	6 hours
Primary	12 hours tramadol consumption	Total tramadol consumption in milligrams at 12 hrs will be scored.	12 hours
Primary	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
Primary	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
Primary	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	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