Anesthesia, LocalNCT03016117
Anesthetic Efficacy of PECS II Block and Parasternal Block
A study testing Pecs II block and parasternal block in people with Anesthesia, Local, run by San Salvatore Hospital of L'Aquila at 1 site in Italy.
Trial summary
The study evaluate the anesthetic efficacy of Pecs II block II and parasternal block during quadrantectomy with or without axillary dissection, in breast cancer surgery Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Pecs II block and parasternal block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteItaly
- Study dates
- 15 Mar 2017to 29 Nov 2018
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who need of quadrantectomy with or without axillary dissection
- ASA I-III patients
- age between 18 and 75 years
- filled informed consent
Who cannot join
- pregnant women
- obesity (BMI > 39,99)
- radical mastectomy
- ASA IV patients
- chest wall abnormalities
- neurological disorders
Show all 9Show fewer
- septic status
- chest skin infections
- coagulopathies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anesthetic Efficacy of PECS II Block and Parasternal Block for Quadrantectomy With or Without Axillary Dissection
The study evaluate the anesthetic efficacy of Pecs II block II and parasternal block during quadrantectomy with or without axillary dissection, in breast cancer surgery
Read the detailed description
All patients receive Pecs II block and parasternal block, under ultrasound guidance. Pecs II block, performed at the 4th rib level, and parasternal block performed at the level of the 2nd and 4th intercostal space level. Data on the anesthesia, side effects and pain, will be recorded
- Conditions
- Anesthesia, Local
- Being tested
- Pecs II block and parasternal block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pecs II block and parasternal blockProcedure or surgery
The Pecs II block will be performed under ultrasound guidance, at fourth rib level, on the axillary line, into the fascial plane between pectoralis minor muscle and serratus muscle. The parasternal block will be performed under ultrasound guidance, at the second and fourth intercostal space, between the pectoralis major muscle and the intercostal muscles, near to the external intercostal membrane.
| Study group | Role | What they receive |
|---|---|---|
| Pecs II block and parasternal block | Experimental | Pecs II block and parasternal block performed to provide anesthesia of breast, before of quadrantectomy with or without axillary dissection. Pecs II block performed at the 4th rib level and 20 ml of 0.5% Levobupivacaine injected, and parasternal block performed at the level of the 2nd and 4th intercostal space level, and 4 ml of 0.375% Levobupivacaine injected Receives: Procedure: Pecs II block and parasternal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthetic efficacy
The anesthetic efficacy is tested by cold and touch test
Measured: The anesthetic efficacy was assessed in the first 72 hours, after block
Secondary outcomes (2)
Painkillers request
mg of morphine
Measured: The painkillers request was assessed in the first 72 hours, after surgery
Side effects
Nausea, vomiting, local anesthetic systemic toxicity
Measured: The side effects recorded in the first 72 hours, after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study start15 Mar 2017
- Primary completion25 Oct 2017
- Study completion29 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 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
- Pierfrancesco Fusco, MDD, Principal investigator, San Salvatore Academic Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03016117
- Sponsor's protocol ID
- SanSalvatoreH
- Status last verified
- Jan 2019
- First submitted
- 6 Jan 2017
- Last updated
- 23 Jan 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 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthetic Efficacy of PECS II Block and Parasternal Block for Quadrantectomy With or Without Axillary Dissection
- ClinicalTrials.gov ID
- NCT03016117
- Acronym / sponsor ID
- SanSalvatoreH
- Conditions
- Anesthesia, Local
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- San Salvatore Hospital of L'AquilaUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 25 Oct 2017 (actual)
- Study completion
- 29 Nov 2018 (actual)
- First posted
- 10 Jan 2017 (estimated)
- 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.
The study evaluate the anesthetic efficacy of Pecs II block II and parasternal block during quadrantectomy with or without axillary dissection, in breast cancer surgery
Detailed description
All patients receive Pecs II block and parasternal block, under ultrasound guidance. Pecs II block, performed at the 4th rib level, and parasternal block performed at the level of the 2nd and 4th intercostal space level. Data on the anesthesia, side effects and pain, will be recorded
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pecs II block and parasternal block | Experimental | Procedure: Pecs II block and parasternal blockPecs II block and parasternal block performed to provide anesthesia of breast, before of quadrantectomy with or without axillary dissection. Pecs II block performed at the 4th rib level and 20 ml of 0.5% Levobupivacaine injected, and parasternal block performed at the level of the 2nd and 4th intercostal space level, and 4 ml of 0.375% Levobupivacaine injected |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients who need of quadrantectomy with or without axillary dissection
- ASA I-III patients
- age between 18 and 75 years
- filled informed consent
Key exclusion criteria (9 listed)
- pregnant women
- obesity (BMI > 39,99)
- radical mastectomy
- ASA IV patients
- chest wall 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 |
|---|---|---|
| Pecs II block and parasternal blockThe Pecs II block will be performed under ultrasound guidance, at fourth rib level, on the axillary line, into the fascial plane between pectoralis minor muscle and serratus muscle. The parasternal block will be performed under ultrasound guidance, at the second and fourth intercostal space, between the pectoralis major muscle and the intercostal muscles, near to the external intercostal membrane. | Procedure or surgery | Pecs II block and parasternal block |
Primary outcome
Anesthetic efficacy
Time frame: The anesthetic efficacy was assessed in the first 72 hours, after block
The anesthetic efficacy is tested by cold and touch test
2 secondary outcomes
Painkillers request
Time frame: The painkillers request was assessed in the first 72 hours, after surgery
Side effects
Time frame: The side effects recorded in the first 72 hours, after surgery
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 Jan 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.
Pierfrancesco Fusco, MDD principal investigator
San Salvatore Academic Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pecs II block and parasternal block in people with Anesthesia, Local, 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 4 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 Jan 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?
Anesthetic efficacy (time frame: The anesthetic efficacy was assessed in the first 72 hours, after block). 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 Jan 2019; AzTrials last refreshed its copy on 7 Nov 2026.