Somatic PainTEACNCT03409068
C2-C4 Compartment Block Versus Block of Costagliola, in TEAC
A study testing C2-C4 compartment anesthetic block and Costagliola block in people with Somatic Pain and Neuropathic Pain, run by San Salvatore Hospital of L'Aquila at 1 site in Italy.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Somatic Pain, Neuropathic Pain
- What is being tested?
- C2-C4 compartment anesthetic block and Costagliola block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 28 Mar 2018to 18 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing to carotid thromboendarterectomy
Who cannot join
- ASA status: 4
- pregnancy
- BMI > 39,99
- neurological impairment
- neck anatomical abnormalities
- status of sepsis
Show all 9Show fewer
- coagulopathy
- neck cancer
- neck infections
Trial locations and contacts
1 site in 1 country.
Italy1 site
SS Filippo and Nicola Academic Hospital of Avezzano
Avezzano, L'Aquila, 67051
About this study
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
C2-C4 compartment block compared to the Costaiola block, in the control of persistent postoperative pain (somatic and neuropathic) in patients undergoing carotid thromboendarterectomy
Read the 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
- Being tested
- C2-C4 compartment anesthetic block, Costagliola block
- Keywords
- Carotid thromboendarterectomy, Carotidodynia
- Medical subject headings
- Nociceptive Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C2-C4 compartment anesthetic blockProcedure or surgery
Also called Intermediate cervical plexus 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 blockProcedure or surgery
Also called Superficial cervical plexus block
Costagliola block is performed by injected by injecting levobupivacaine 0.375% 20 mL along the anterior and the posterior border of sternocleidomastoid muscle
| Study group | Role | What they receive |
|---|---|---|
| C2-C4 compartment block | Experimental | 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. Receives: Procedure: C2-C4 compartment anesthetic block |
| Costagliola block | Active comparator | 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. Receives: Procedure: Costagliola block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 3 mounths after surgery
Secondary outcomes (3)
Opiates request
Request of opiates, assessed in mg of equianalgesic dose of morphine after 3 mouths from surgery
Measured: 3 mounths after surgery
Pregabalin request
Pregabalin request in mg, 3 months after surgery
Measured: 3 months
Neuropathic pain
Presence of neuropathic disturbances, assessed with von Frey hair test and Lindblom test
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start28 Mar 2018
- Primary completion28 Nov 2018
- Study completion18 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Somatic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Salvatore Hospital of L'Aquila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emiliano Petrucci, San Salvatore Hospital of L'Aquila
- Investigators
- Emiliano Petrucci, MD, Principal investigator, SS Filippo and Nicola Academic Hospital of Avezzano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409068
- Sponsor's protocol ID
- 0174363/2017
- Acronym
- TEAC
- Status last verified
- Apr 2019
- First submitted
- 17 Jan 2018
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03409068
- Acronym / sponsor ID
- TEAC / 0174363/2017
- Conditions
- Somatic Pain, Neuropathic Pain
- Keywords
- Carotid thromboendarterectomy, Carotidodynia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- San Salvatore Hospital of L'AquilaUniversity, hospital or other
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 28 Nov 2018 (actual)
- Study completion
- 18 Jan 2019 (actual)
- First posted
- 24 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C2-C4 compartment block | Experimental | Procedure: C2-C4 compartment anesthetic blockExperimental: 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. |
| Costagliola block | Active comparator | Procedure: Costagliola blockActive 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing to carotid thromboendarterectomy
Key exclusion criteria (9 listed)
- ASA status: 4
- pregnancy
- BMI > 39,99
- neurological impairment
- neck anatomical abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C2-C4 compartment anesthetic blockAlso: Intermediate cervical plexus blockC2-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. | Procedure or surgery | C2-C4 compartment block |
| Costagliola blockAlso: Superficial cervical plexus blockCostagliola block is performed by injected by injecting levobupivacaine 0.375% 20 mL along the anterior and the posterior border of sternocleidomastoid muscle | Procedure or surgery | Costagliola block |
Primary outcome
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"
3 secondary outcomes
Opiates request
Time frame: 3 mounths after surgery
Pregabalin request
Time frame: 3 months
Neuropathic pain
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emiliano Petrucci, MD principal investigator
SS Filippo and Nicola Academic Hospital of Avezzano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C2-C4 compartment anesthetic block and Costagliola block in people with Somatic Pain and Neuropathic Pain, run by San Salvatore Hospital of L'Aquila at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
somatic pain (time frame: 3 mounths after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2019.