NCT04224844

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
34

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

April 30, 2020

Status Verified

April 1, 2020

Enrollment Period

3 months

First QC Date

January 7, 2020

Last Update Submit

April 29, 2020

Conditions

Pain

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (1)

  • Amount of use of intraoperative local anesthetic.

    1 hour

Study Arms (2)

Erector spinae plane block group (Group 1)

ACTIVE COMPARATOR

Patients will receive erector spinae plane block in addition to intravenous patient-controlled analgesia device containing tramadol.

Other: Erector spinae plane block

Control group (Group 2)

ACTIVE COMPARATOR

Control group will receive only intravenous patient-controlled analgesia device containing tramadol.

Other: Control group

Interventions

Erector spinae plane blockOTHER

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.

Erector spinae plane block group (Group 1)
Control groupOTHER

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

Control group (Group 2)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing carotid endarterectomy
  • American Society of Anesthesiologists class 2 to 3
  • Ability to consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya Training and Reseach Hospital

Antalya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Ali Sait Kavakli, M.D.

    Antalya Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2020

First Posted

January 13, 2020

Study Start

September 1, 2020

Primary Completion

December 1, 2020

Study Completion

February 1, 2021

Last Updated

April 30, 2020

Record last verified: 2020-04

Locations

TU(1)