Erector Spinae Plane Block for Carotid Endarterectomy

Not Applicable

Suspended

• Conditions: Pain
• Interventions: Other: Control group; Other: Erector spinae plane block

• Registration Number: NCT04224844
• Lead Sponsor: Antalya Training and Research Hospital

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.

Study Timeline

• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-08
• Study First Posted: 2020-01-13
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-29
• Last Update Posted: 2020-04-30
• Study Start: 2020-09
• Primary Completion: 2020-12
• Study Completion: 2021-02

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group (Group 2)	Control group	Control group will receive only intravenous patient-controlled analgesia device containing tramadol.
Erector spinae plane block group (Group 1)	Erector spinae plane block	Patients will receive erector spinae plane block in addition to intravenous patient-controlled analgesia device containing tramadol.

Primary Outcome Measures

Name	Time	Method
24 hours tramadol consumption	24 hours	Total tramadol consumption in milligrams at 24 hrs will be scored.
6 hours tramadol consumption	6 hours	Total tramadol consumption in milligrams at 6 hrs will be scored.
12 hours tramadol consumption	12 hours	Total tramadol consumption in milligrams at 12 hrs will be scored.
Assesment of postoperative analgesia	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.

Secondary Outcome Measures

Name	Time	Method
Amount of use of intraoperative local anesthetic.	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.

Trial Locations

Locations (1)

Antalya Training and Reseach Hospital; 🇹🇷 Antalya, Turkey