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

NCT ID: NCT03409068

Last Updated: 2019-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-28
• Study Completion Date: 2019-01-18

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

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.

Conditions

Somatic Pain; Neuropathic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

C2-C4 compartment anesthetic block

Intervention Type: PROCEDURE

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.

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.

Group Type: ACTIVE_COMPARATOR

Costagliola block

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: 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

Intervention Type: PROCEDURE

Other Intervention Names

Intermediate cervical plexus block; Superficial cervical plexus block

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

San Salvatore Hospital of L'Aquila

OTHER

Sponsor Role: lead

Responsible Party

Emiliano Petrucci

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emiliano Petrucci, MD

Role: PRINCIPAL_INVESTIGATOR

SS Filippo and Nicola Academic Hospital of Avezzano

Locations

SS Filippo and Nicola Academic Hospital of Avezzano

Avezzano, L'Aquila, Italy

Countries

Italy

Other Identifiers

0174363/2017

Identifier Type: -

Identifier Source: org_study_id