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

Neuropathic Pain Clinical Trial

— TEAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03409068
• Other study ID #: 0174363/2017
• Status: Completed
• Phase: N/A
• Start date: March 28, 2018
• Est. completion date: January 18, 2019

Study information

• Verified date: April 2019
• Source: San Salvatore Hospital of L'Aquila
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 18, 2019
• Est. primary completion date: November 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Nociceptive Pain
• Somatic Pain

Intervention

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.
• 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

Locations

Country	Name	City	State
Italy	SS Filippo and Nicola Academic Hospital of Avezzano	Avezzano	L'Aquila

Sponsors (1)

Lead Sponsor	Collaborator
San Salvatore Hospital of L'Aquila

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Opiates request	Request of opiates, assessed in mg of equianalgesic dose of morphine after 3 mouths from surgery	3 mounths after surgery
Secondary	Pregabalin request	Pregabalin request in mg, 3 months after surgery	3 months
Secondary	Neuropathic pain	Presence of neuropathic disturbances, assessed with von Frey hair test and Lindblom test	3 months