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

Primary Purpose

Somatic Pain, Neuropathic Pain

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
C2-C4 compartment anesthetic block
Costagliola block
Sponsored by
San Salvatore Hospital of L'Aquila
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Somatic Pain focused on measuring Carotid thromboendarterectomy, Carotidodynia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • SS Filippo and Nicola Academic Hospital of Avezzano

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

C2-C4 compartment block

Costagliola block

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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"

Secondary Outcome Measures

Opiates request
Request of opiates, assessed in mg of equianalgesic dose of morphine after 3 mouths from surgery
Pregabalin request
Pregabalin request in mg, 3 months after surgery
Neuropathic pain
Presence of neuropathic disturbances, assessed with von Frey hair test and Lindblom test

Full Information

First Posted
January 17, 2018
Last Updated
April 21, 2019
Sponsor
San Salvatore Hospital of L'Aquila
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1. Study Identification

Unique Protocol Identification Number
NCT03409068
Brief Title
C2-C4 Compartment Block Versus Block of Costagliola, in TEAC
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 28, 2018 (Actual)
Primary Completion Date
November 28, 2018 (Actual)
Study Completion Date
January 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Salvatore Hospital of L'Aquila

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Somatic Pain, Neuropathic Pain
Keywords
Carotid thromboendarterectomy, Carotidodynia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
C2-C4 compartment block
Arm Type
Experimental
Arm Description
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.
Arm Title
Costagliola block
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
C2-C4 compartment anesthetic block
Other Intervention Name(s)
Intermediate cervical plexus block
Intervention Description
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
Intervention Name(s)
Costagliola block
Other Intervention Name(s)
Superficial cervical plexus block
Intervention Description
Costagliola block is performed by injected by injecting levobupivacaine 0.375% 20 mL along the anterior and the posterior border of sternocleidomastoid muscle
Primary Outcome Measure Information:
Title
somatic pain
Description
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"
Time Frame
3 mounths after surgery
Secondary Outcome Measure Information:
Title
Opiates request
Description
Request of opiates, assessed in mg of equianalgesic dose of morphine after 3 mouths from surgery
Time Frame
3 mounths after surgery
Title
Pregabalin request
Description
Pregabalin request in mg, 3 months after surgery
Time Frame
3 months
Title
Neuropathic pain
Description
Presence of neuropathic disturbances, assessed with von Frey hair test and Lindblom test
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emiliano Petrucci, MD
Organizational Affiliation
SS Filippo and Nicola Academic Hospital of Avezzano
Official's Role
Principal Investigator
Facility Information:
Facility Name
SS Filippo and Nicola Academic Hospital of Avezzano
City
Avezzano
State/Province
L'Aquila
ZIP/Postal Code
67051
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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