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Completed

NCT Number: NCT03409068

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

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

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Key information

Conditions

Somatic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Nociceptive Pain Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SS Filippo and Nicola Academic Hospital of Avezzano

Avezzano, L'Aquila, 67051, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

C2-C4 compartment anesthetic block

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.

Other names: Intermediate cervical plexus block

Costagliola block

Procedure

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

Primary outcomes

  1. 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"

Secondary outcomes

  1. Opiates request

    Time frame: 3 mounths after surgery

    Request of opiates, assessed in mg of equianalgesic dose of morphine after 3 mouths from surgery

  2. Pregabalin request

    Time frame: 3 months

    Pregabalin request in mg, 3 months after surgery

  3. Neuropathic pain

    Time frame: 3 months

    Presence of neuropathic disturbances, assessed with von Frey hair test and Lindblom test

Sponsors and collaborators

Lead sponsor

San Salvatore Hospital of L'Aquila

Other

Registry information

Official study title

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

Acronym: TEAC

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jan 24, 2018
Registry last updated
Apr 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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