C2-C4 Compartment Block Versus Block of Costagliola, in TEAC (TEAC)

April 21, 2019 updated by: Emiliano Petrucci, San Salvatore Hospital of L'Aquila

The Effectiveness of C2-C4 Compartment Block Versus Block of Costagliola, in the Control of Persistent Postoperative Pain in Patients Undergoing Carotid Thromboendarterectomy

C2-C4 compartment block compared to the Costaiola block, in the control of persistent postoperative pain (somatic and neuropathic) in patients undergoing carotid thromboendarterectomy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A comparative analysis will assess the somatic pain (scores ≥4 on the NRS scale) and neurapathic pain (by the Lindblom roller and Von Frei hair tests) between group A (block group of the C2-C4 compartment ) and the control group B (block group according to Costagliola), during the 3 months after surgery.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • L'Aquila
      • Avezzano, L'Aquila, Italy, 67051
        • SS Filippo and Nicola Academic Hospital of Avezzano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 to carotid thromboendarterectomy

Exclusion Criteria:

  • ASA status: 4
  • pregnancy
  • BMI > 39,99
  • neurological impairment
  • neck anatomical abnormalities
  • status of sepsis
  • coagulopathy
  • neck cancer
  • neck infections

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: C2-C4 compartment block
Experimental: the C2-C4 compartment anesthetic block is performed by injecting Levobupivacaine 0.375% 20 mL between the posterior face of the middle scalenous muscle, the anterior face of the posterior scalene muscle and the lower plane of the sternoscleidomastoid muscle.
Procedure: C2-C4 compartment anesthetic block
C2-C4 compartment anesthetic block is performed by injecting levobupivacaine 0.375% 20 mL between the posterior face of the middle scalenus muscle, the anterior face of the posterior scalene muscle and the lower plane of the sternoscleidomastoid muscle.
Other Names:
  • Intermediate cervical plexus block
ACTIVE_COMPARATOR: Costagliola block
Active Comparator: the Costagliola anesthetic block is performed by injecting Levobupivacaine 0.375% 20 mL injected in the posterior margin of the sternocleidomastoid muscle and along the anterior border of the same muscle.
Procedure: Costagliola block
Costagliola block is performed by injected by injecting levobupivacaine 0.375% 20 mL along the anterior and the posterior border of sternocleidomastoid muscle
Other Names:
  • Superficial cervical plexus block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
somatic pain
Time Frame: 3 mounths after surgery
Somatic pain assessed by Numeric Pain Rating Scale for pain (the 11-point numeric scale ranges from '0' representing "no pain" to '10' representing the "worst pain imaginable"
3 mounths after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opiates request
Time Frame: 3 mounths after surgery
Request of opiates, assessed in mg of equianalgesic dose of morphine after 3 mouths from surgery
3 mounths after surgery
Pregabalin request
Time Frame: 3 months
Pregabalin request in mg, 3 months after surgery
3 months
Neuropathic pain
Time Frame: 3 months
Presence of neuropathic disturbances, assessed with von Frey hair test and Lindblom test
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Salvatore Hospital of L'Aquila

Investigators

  • Principal Investigator: Emiliano Petrucci, MD, SS Filippo and Nicola Academic Hospital of Avezzano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 28, 2018

Primary Completion (ACTUAL)

November 28, 2018

Study Completion (ACTUAL)

January 18, 2019

Study Registration Dates

First Submitted

January 17, 2018

First Submitted That Met QC Criteria

January 23, 2018

First Posted (ACTUAL)

January 24, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 23, 2019

Last Update Submitted That Met QC Criteria

April 21, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0174363/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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