Breast CancerNCT02865265
Pecs II Block and PaB Could be an Alternative in Breast Surgery
An observational study of Breast Cancer, run by Emiliano Petrucci.
Trial summary
The association between ultrasound-guided Pecs II block and parasternal block can represent a valid alternative in the management of acute and postoperative pain syndrome after quadrantectomy with or without axillary dissection. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Pecs II and parasternal blocks
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Dec 2015
- Phase
- Observational
- 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
Study population: Patients scheduled for quadrantectomy with or without axillary dissection.
Who may be able to join
- 18-75 years of age;
- American Society of Anesthesiologists (ASA) physical status I-III,
- patients scheduled for quadrantectomy with or without axillary dissection
Who cannot join
- pregnancy;
- body mass index (BMI) >35;
- allergy to local anesthetics;
- skeletal or muscle abnormalities of the chest wall;
- presence of primary or secondary neurological diseases;
- presence of psychiatric diseases;
Show all 13Show fewer
- history of chronic pain or neuropathic disorders;
- history of drug abuse;
- state of sepsis;
- infection
- tumors of the skin on the chest;
- primary;
- secondary coagulopathies
About this study
Official title: Association Between Ultrasound-guided Pecs II Block and Parasternal Block May Represent a Valid Alternative for the Management of Acute and Postoperative Pain Syndrome in Breast Cancer Surgery: a Retrospective Study
The association between ultrasound-guided Pecs II block and parasternal block can represent a valid alternative in the management of acute and postoperative pain syndrome after quadrantectomy with or without axillary dissection.
Read the detailed description
The combination of Pecs II block and PaB provides good management of postoperative pain and can be considered a viable alternative to common anesthetic procedures performed for breast cancer surgery.
- Conditions
- Breast Cancer
- Being tested
- Pecs II and parasternal blocks
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pecs II and parasternal blocksProcedure or surgery
Pecs II block was performed at the level of the fourth rib in the fascial plane between the minor pectoral and serratus anterior muscles, and 20 ml of 0.5% levobupivacaine solution were injected.
An ultrasound-guided ipsilateral parasternal block was performed via two separate injections of 4 ml of 0.375% levobupivacaine at the level of the 2nd and 4th intercostal space underneath the external intercostal membrane between the major pectoral and intercostal muscles close to the surface of the 2nd and 4th rib.
| Study group | Role | What they receive |
|---|---|---|
| Pecs II and parasternal blocks | Pecs II block was performed at the level of the fourth rib in the fascial plane between the minor pectoral and serratus anterior muscles, and 20 ml of 0.5% levobupivacaine solution were injected.
An ultrasound-guided ipsilateral PaB was performed via two separate injections of 4 ml of 0.375% levobupivacaine at the level of the 2nd and 4th intercostal space underneath the external intercostal membrane between the major pectoral and intercostal muscles close to the surface of the 2nd and 4th rib. Receives: Procedure: Pecs II and parasternal blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Pain has been evaluate with visual analogue scale (VAS) at 24 months after surgery
Measured: Pain was recorded at 24 months after surgery
Secondary outcomes (3)
Neuropathic postoperative disturbances
Neuropathic postoperative disturbances were examined using the von Frey hair test (neuropathic disturbances: present/not present) at 24 months
Measured: Neuropathic postoperative disturbances were recorded at 24 months after surgery
Patient satisfaction
Patient satisfaction with regard to the anesthetic procedure was assessed using a five-step satisfaction scale (not at all/slightly/somewhat/very/extremely satisfied).
Measured: Patient satisfaction was evaluated at 1 day after surgery
Woud healing
Wound healing was assessed using a three-step scale (unacceptable/acceptable/excellent healing) in accordance with the surgeon's opinion.
Measured: Wound healing was assessed at 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startMar 2013
- Primary completionMar 2013
- Study completionDec 2015
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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emiliano Petrucci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emiliano Petrucci, San Salvatore Hospital of L'Aquila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865265
- Sponsor's protocol ID
- 0109060/16
- Status last verified
- Aug 2016
- First submitted
- 4 Aug 2016
- Last updated
- 12 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Ultrasound-guided Pecs II Block and Parasternal Block May Represent a Valid Alternative for the Management of Acute and Postoperative Pain Syndrome in Breast Cancer Surgery: a Retrospective Study
- ClinicalTrials.gov ID
- NCT02865265
- Acronym / sponsor ID
- 0109060/16
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Emiliano PetrucciUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 12 Aug 2016 (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 association between ultrasound-guided Pecs II block and parasternal block can represent a valid alternative in the management of acute and postoperative pain syndrome after quadrantectomy with or without axillary dissection.
Detailed description
The combination of Pecs II block and PaB provides good management of postoperative pain and can be considered a viable alternative to common anesthetic procedures performed for breast cancer surgery.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pecs II and parasternal blocks | – | Procedure: Pecs II and parasternal blocksPecs II block was performed at the level of the fourth rib in the fascial plane between the minor pectoral and serratus anterior muscles, and 20 ml of 0.5% levobupivacaine solution were injected. An ultrasound-guided ipsilateral PaB was performed via two separate injections of 4 ml of 0.375% levobupivacaine at the level of the 2nd and 4th intercostal space underneath the external intercostal membrane between the major pectoral and intercostal muscles close to the surface of the 2nd and 4th rib. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for quadrantectomy with or without axillary dissection.
Key inclusion criteria (3 listed)
- 18-75 years of age;
- American Society of Anesthesiologists (ASA) physical status I-III,
- patients scheduled for quadrantectomy with or without axillary dissection
Key exclusion criteria (13 listed)
- pregnancy;
- body mass index (BMI) >35;
- allergy to local anesthetics;
- skeletal or muscle abnormalities of the chest wall;
- presence of primary or secondary neurological diseases;
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 blocksPecs II block was performed at the level of the fourth rib in the fascial plane between the minor pectoral and serratus anterior muscles, and 20 ml of 0.5% levobupivacaine solution were injected. An ultrasound-guided ipsilateral parasternal block was performed via two separate injections of 4 ml of 0.375% levobupivacaine at the level of the 2nd and 4th intercostal space underneath the external intercostal membrane between the major pectoral and intercostal muscles close to the surface of the 2nd and 4th rib. | Procedure or surgery | Pecs II and parasternal blocks |
Primary outcome
Pain
Time frame: Pain was recorded at 24 months after surgery
Pain has been evaluate with visual analogue scale (VAS) at 24 months after surgery
3 secondary outcomes
Neuropathic postoperative disturbances
Time frame: Neuropathic postoperative disturbances were recorded at 24 months after surgery
Patient satisfaction
Time frame: Patient satisfaction was evaluated at 1 day after surgery
Woud healing
Time frame: Wound healing was assessed at 24 months 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 12 Aug 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Emiliano Petrucci.
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 3 inclusion and 13 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 12 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Pain (time frame: Pain was recorded at 24 months 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 12 Aug 2016.