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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Somatic Pain, Neuropathic Pain

Intervention / Treatment
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* Procedure: C2-C4 compartment anesthetic block
* Procedure: Costagliola block


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C2-C4 compartment block<br>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<br>* 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.<br>* Other names: Intermediate cervical plexus block;|
| Active Comparator: Costagliola block<br>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<br>* Costagliola block is performed by injected by injecting levobupivacaine 0.375% 20 mL along the anterior and the posterior border of sternocleidomastoid muscle<br>* Other names: Superficial cervical plexus block;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carotid thromboendarterectomy, Carotidodynia