NCT03409068

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 28, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2019

Completed
Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

8 months

First QC Date

January 17, 2018

Last Update Submit

April 21, 2019

Conditions

Somatic PainNeuropathic Pain

Keywords

Carotid thromboendarterectomyCarotidodynia

Outcome Measures

Primary Outcomes (1)

  • somatic pain

    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 Outcomes (3)

  • Opiates request

    3 mounths after surgery

  • Pregabalin request

    3 months

  • Neuropathic pain

    3 months

Study Arms (2)

C2-C4 compartment block

EXPERIMENTAL

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

Costagliola block

ACTIVE COMPARATOR

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

Interventions

C2-C4 compartment anesthetic blockPROCEDURE

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.

Also known as: Intermediate cervical plexus block
C2-C4 compartment block
Costagliola blockPROCEDURE

Costagliola block is performed by injected by injecting levobupivacaine 0.375% 20 mL along the anterior and the posterior border of sternocleidomastoid muscle

Also known as: Superficial cervical plexus block
Costagliola block

Eligibility Criteria

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

You may qualify if:

  • patients undergoing to carotid thromboendarterectomy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SS Filippo and Nicola Academic Hospital of Avezzano

Avezzano, L'Aquila, 67051, Italy

Location

MeSH Terms

Conditions

Nociceptive PainNeuralgia

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Emiliano Petrucci, MD

    SS Filippo and Nicola Academic Hospital of Avezzano

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

January 17, 2018

First Posted

January 24, 2018

Study Start

March 28, 2018

Primary Completion

November 28, 2018

Study Completion

January 18, 2019

Last Updated

April 23, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)