MastectomyNCT03177733
Evaluation of a Breast Double Block Analgesia for the Mastectomy With Radical Axillary Lymphadenectomy Surgery
An observational study of Mastectomy, run by Maison de Santé Prostestante de Bordeaux Bagatelle at 1 site in France.
Trial summary
This study evaluates the efficacy of the the pecto-intercostal fascial plane block (PIF block) for the anesthesia of the intercostal nerves anterior branches and assesses the association of the serratus block with a PIF block for the breast surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mastectomy
- What is being tested?
- Evaluation of a breast double block
- Type of treatment
- Surgery or procedure
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2017to 1 Jul 2018
- 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 years and older
- Women only
- Adult, Older adult
Study population: All patients included in the study have had a total mastectomy surgery with a complete axillary lymph nodes removal.
Who may be able to join
- total mastectomy surgery with a complete axillary lymph nodes removal
Who cannot join
- age under 18
- contraindication to the surgery
- refusal of the protocol by the patient
Trial locations and contacts
1 site in 1 country.
France1 site
Maison de Santé Protestante de Bordeaux-Bagatelle
Talence, Aquitaine, 33401
About this study
This study evaluates the efficacy of the the pecto-intercostal fascial plane block (PIF block) for the anesthesia of the intercostal nerves anterior branches and assesses the association of the serratus block with a PIF block for the breast surgery.
To obtain a correct prospective clinical trial completion we have to begin a new series of inclusion.
Read the detailed description
Breast surgery is one of the most painful post-operative surgery. This surgery is well known to induce postoperative chronic pain. The paravertebral block, because of its efficacy and less invasive nature than epidural analgesia, is quickly becoming the reference technique for pain management of major breast surgery.
Peripheral regional anesthesia for the breast surgery appeared in the past few years. Among these techniques are the PEC block, Serratus block and more recently the pecto-intercostal fascial plane block (PIF block).
Currently in our hospital in every day's practice, we made an association of the serratus block and the PIF block, which allows for a complete block of both the laterals branches of intercostal nerves (with the serratus block) and of anterior branches of intercostal nerves (with the PIF block). Therefore, this association of blocks may lead to a complete analgesia of the breast, while the serratus block alone only allows for an analgesia of the lateral part of the breast.
This technique was described by Fajardo et al. They evoked the possibility of the association serratus and PIF blocks and described this technique with a patient, but to our knowledge no evaluation of the efficacy of this procedure was made.
The objective of your study is to analyze this technique through a collection form that evaluates the satisfaction and post-operative morphine consumption of women receiving this association of blocks before a general anesthesia for a unilateral mastectomy with homolateral total lymphadenectomy.
This is a purely observational study that assesses our current practice in this type of surgery.
we already included a patient series but the clinical trial registration was made to late to do it correctly. To obtain a correct prospective clinicaltrials registration completion we have to begin a new series of inclusion.
- Conditions
- Mastectomy
- Being tested
- Evaluation of a breast double block
- Keywords
- breast surgery, acute pain, regional anesthesia
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of a breast double blockProcedure or surgery
we made an association of the serratus block and the PIF block, which allows for a complete block of both the laterals branches of intercostal nerves (with the serratus block) and of anterior branches of intercostal nerves (with the PIF block). Therefore, this association of blocks may lead to a complete analgesia of the breast, while the serratus block alone only allows for an analgesia of the lateral part of the breast.
The objective is to analyze this technique through a collection form that evaluates the satisfaction and post-operative morphine consumption of women receiving this association before a general anesthesia for a unilateral mastectomy with homolateral total lymphadenectomy.
This is a purely observational study that assesses our current practice in this type of surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative morphine consumption until 72 hours after the surgery.
The primary goal of the study is to evaluate the postoperative morphine consumption until 72 hours after the surgery.
Measured: 3 days
Secondary outcomes (2)
Pain levels during the first 72 hours.
Pain levels on a numeric pain rating scale were recorded at rest and with arm mobilization during the first 72 hours.
Measured: 3 days
Level of comfort during the first 72 hours
level of comfort during the first 72 hours was recorded (the 4 levels-scale used was: excellent, good, medium and bad).
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start20 Jun 2017
- Primary completion1 Jun 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MastectomyStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maison de Santé Prostestante de Bordeaux Bagatelle
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Claude-Charles Balick-Weber, Maison de Santé Prostestante de Bordeaux Bagatelle
- Investigators
- Claude-charles Balick-weber, Principal investigator, Maison de Santé Protestante de Bordeaux-Bagatelle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177733
- Sponsor's protocol ID
- Evaluation of breast biblock 2
- Status last verified
- Nov 2018
- First submitted
- 2 Jun 2017
- Last updated
- 28 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Breast Double Block Analgesia for the Mastectomy With Radical Axillary Lymphadenectomy Surgery
- ClinicalTrials.gov ID
- NCT03177733
- Acronym / sponsor ID
- Evaluation of breast biblock 2
- Conditions
- Mastectomy
- Keywords
- breast surgery, acute pain, regional anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Maison de Santé Prostestante de Bordeaux BagatelleUniversity, hospital or other
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 6 Jun 2017 (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.
This study evaluates the efficacy of the the pecto-intercostal fascial plane block (PIF block) for the anesthesia of the intercostal nerves anterior branches and assesses the association of the serratus block with a PIF block for the breast surgery.
To obtain a correct prospective clinical trial completion we have to begin a new series of inclusion.
Detailed description
Breast surgery is one of the most painful post-operative surgery. This surgery is well known to induce postoperative chronic pain. The paravertebral block, because of its efficacy and less invasive nature than epidural analgesia, is quickly becoming the reference technique for pain management of major breast surgery.
Peripheral regional anesthesia for the breast surgery appeared in the past few years. Among these techniques are the PEC block, Serratus block and more recently the pecto-intercostal fascial plane block (PIF block).
Currently in our hospital in every day's practice, we made an association of the serratus block and the PIF block, which allows for a complete block of both the laterals branches of intercostal nerves (with the serratus block) and of anterior branches of intercostal nerves (with the PIF block). Therefore, this association of blocks may lead to a complete analgesia of the breast, while the serratus block alone only allows for an analgesia of the lateral part of the breast.
This technique was described by Fajardo et al. They evoked the possibility of the association serratus and PIF blocks and described this technique with a patient, but to our knowledge no evaluation of the efficacy of this procedure was made.
The objective of your study is to analyze this technique through a collection form that evaluates the satisfaction and post-operative morphine consumption of women receiving this association of blocks before a general anesthesia for a unilateral mastectomy with homolateral total lymphadenectomy.
This is a purely observational study that assesses our current practice in this type of surgery.
we already included a patient series but the clinical trial registration was made to late to do it correctly. To obtain a correct prospective clinicaltrials registration completion we have to begin a new series of inclusion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- All patients included in the study have had a total mastectomy surgery with a complete axillary lymph nodes removal.
Key inclusion criteria (1 listed)
- total mastectomy surgery with a complete axillary lymph nodes removal
Key exclusion criteria (3 listed)
- age under 18
- contraindication to the surgery
- refusal of the protocol by the patient
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 |
|---|---|---|
| Evaluation of a breast double blockwe made an association of the serratus block and the PIF block, which allows for a complete block of both the laterals branches of intercostal nerves (with the serratus block) and of anterior branches of intercostal nerves (with the PIF block). Therefore, this association of blocks may lead to a complete analgesia of the breast, while the serratus block alone only allows for an analgesia of the lateral part of the breast. The objective is to analyze this technique through a collection form that evaluates the satisfaction and post-operative morphine consumption of women receiving this association before a general anesthesia for a unilateral mastectomy with homolateral total lymphadenectomy. This is a purely observational study that assesses our current practice in this type of surgery. | Procedure or surgery | – |
Primary outcome
postoperative morphine consumption until 72 hours after the surgery.
Time frame: 3 days
The primary goal of the study is to evaluate the postoperative morphine consumption until 72 hours after the surgery.
2 secondary outcomes
Pain levels during the first 72 hours.
Time frame: 3 days
Level of comfort during the first 72 hours
Time frame: 3 days
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 28 Nov 2018.
- Individual participant dataSharing planned: Undecided
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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.
Claude-charles Balick-weber principal investigator
Maison de Santé Protestante de Bordeaux-Bagatelle
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mastectomy, run by Maison de Santé Prostestante de Bordeaux Bagatelle at 1 site in France.
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 3 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 28 Nov 2018. 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 France. 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 morphine consumption until 72 hours after the surgery. (time frame: 3 days). 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 28 Nov 2018.