Breast CancerNCT03754816
The Combination of PECS II Block and Parasternal Block for Radical Mastectomy
A study testing PECS II and parasternal block and Levobupivacaine in people with Breast Cancer, run by San Salvatore Hospital of L'Aquila at 1 site in Italy.
Trial summary
The combination of PECS II and parasternal Block provides analgesia after radical mastectomy Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- PECS II and parasternal block and Levobupivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2018to 12 Apr 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA status patients:1,2 and 3
- patients undergoing to radical mastectomy with axillary dissection and breast-implant reconstruction
Who cannot join
- patients with allergy to local anesthetics
- ASA status patients: 4
- breast anatomy abnormalities
- neurological diseases
- septic conditions
- coagulopathies
- drug abuse history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Combination of PECS II Block and Parasternal Block Provide Useful Analgesia After Radical Mastectomy With Axillary Dissection and Implant Breast Reconstruction
The combination of PECS II and parasternal Block provides analgesia after radical mastectomy
Read the detailed description
The cambionation of PECS II block and parasternal block
- Conditions
- Breast Cancer
- Being tested
- PECS II and parasternal block, Levobupivacaine
- Keywords
- PECS II block, parasternal block, analgesia
- Medical subject headings
- Breast Neoplasms, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PECS II and parasternal blockProcedure or surgery
Also called Pectoral nerve block II type and parasternal block
10 ml of Levobupivacaine 0.375% injected between minor and major pectoralis muscles. 20 ml of Levobupivacaine 0.375% injected between minor and serratus muscles. 10 ml of Levobupivacaine 0.375% injected between major and intercostal muscles at II and IV intercostal space.
LevobupivacaineDrug
Also called Locali anesthetic
Levobupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The combination of PECS II and parasternal block performed by injecting Levobupivacaine 0.375% 40 ml, injected between minor and major pectoralis muscles, between minor and serratus muscles and between major and intercostal muscles Receives: Procedure: PECS II and parasternal block; Drug: Levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain: Numeric Rate Scale
Postoperative pain evaluated with Numeric Rate Scale, from 0 (no pain) to 10 (worst pain)
Measured: 24 hours after surgery
Secondary outcomes (3)
Intraoperative opiates
Number of patients needing of equianalgesic mg of intraoperative morphine
Measured: From start to the end of surgery
Postoperative opiates
Number of patients needing of equianalgesic mg of postoperative morphine
Measured: 24 hours after surgery
Side effects
Number of patients with postoperative nausea and vomiting
Measured: 24 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 posted27 Nov 2018
- Study start1 Dec 2018
- Primary completion31 Mar 2019
- Study completion12 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Prevention
- 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
- Emiliano Petrucci, Principal investigator, San Salvatore Academic Hospital of L'Aquila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754816
- Sponsor's protocol ID
- 0180910/16
- Status last verified
- Apr 2019
- First submitted
- 25 Nov 2018
- Last updated
- 18 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 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combination of PECS II Block and Parasternal Block Provide Useful Analgesia After Radical Mastectomy With Axillary Dissection and Implant Breast Reconstruction
- ClinicalTrials.gov ID
- NCT03754816
- Acronym / sponsor ID
- 0180910/16
- Conditions
- Breast Cancer
- Keywords
- PECS II block, parasternal block, analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- San Salvatore Hospital of L'AquilaUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 12 Apr 2019 (actual)
- First posted
- 27 Nov 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.
The combination of PECS II and parasternal Block provides analgesia after radical mastectomy
Detailed description
The cambionation of PECS II block and parasternal block
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: PECS II and parasternal block, Drug: LevobupivacaineThe combination of PECS II and parasternal block performed by injecting Levobupivacaine 0.375% 40 ml, injected between minor and major pectoralis muscles, between minor and serratus muscles and between major and intercostal muscles |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA status patients:1,2 and 3
- patients undergoing to radical mastectomy with axillary dissection and breast-implant reconstruction
Key exclusion criteria (7 listed)
- patients with allergy to local anesthetics
- ASA status patients: 4
- breast anatomy abnormalities
- neurological diseases
- septic conditions
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 and parasternal blockAlso: Pectoral nerve block II type and parasternal block10 ml of Levobupivacaine 0.375% injected between minor and major pectoralis muscles. 20 ml of Levobupivacaine 0.375% injected between minor and serratus muscles. 10 ml of Levobupivacaine 0.375% injected between major and intercostal muscles at II and IV intercostal space. | Procedure or surgery | Experimental group |
| LevobupivacaineAlso: Locali anestheticLevobupivacaine | Drug | Experimental group |
Primary outcome
Postoperative pain: Numeric Rate Scale
Time frame: 24 hours after surgery
Postoperative pain evaluated with Numeric Rate Scale, from 0 (no pain) to 10 (worst pain)
3 secondary outcomes
Intraoperative opiates
Time frame: From start to the end of surgery
Postoperative opiates
Time frame: 24 hours after surgery
Side effects
Time frame: 24 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 18 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 principal investigator
San Salvatore Academic Hospital of L'Aquila
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 and parasternal block and Levobupivacaine in people with Breast Cancer, 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 2 inclusion and 7 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 18 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?
Postoperative pain: Numeric Rate Scale (time frame: 24 hours 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 18 Apr 2019; AzTrials last refreshed its copy on 6 Nov 2026.