no Reconstructive Breast SurgeryPhase 4NCT02018601
Intercostal Nerves Block in the Midaxillary Line Versus Paravertebral Block for no Reconstructive Breast Surgery
A Phase 4 study testing BRILMA, paravertebral block and dexketoprofen in people with no Reconstructive Breast Surgery, run by Paula Diéguez García at 1 site in Spain.
Trial summary
The main objectives of the trial are the efficacy and safety of intercostal nerve block in the midaxillary line versus paravertebral block, both guided by ultrasound in patients scheduled for not reconstructive breast surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- no Reconstructive Breast Surgery
- What is being tested?
- BRILMA, paravertebral block and dexketoprofen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2013to Dec 2022
- Phase
- Phase 4
- 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 scheduled for not reconstructive unilateral breast surgery.
- Physical status American Society Anesthesiologists (ASA) I-III.
- Signed informed consent.
- Aged between 18 and 75 years.
- Ability to assess pain using a verbal and numerical scales.
- Assessment of pain at the time of inclusion in the study is lower than 3 verbal simple scale
Who cannot join
- Personal history of disorders of hemostasis or previous history of abnormal bleeding evidence.
- Local infection at the site of the puncture or to puncture prior systemic.
- Contraindications to study medication.
- Muscle or neurological disease, peripheral or central.
- Patients with prior history of opioid.
- Pregnancy or lactation.
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- Difficulties in assessing pain or inability to understand or assist in the development of the study (psychiatric illness, cognitive impairments)
- Active Chronic alcoholism or drug addiction.
- BMI under 20 or mayor 30.
- Chronic treatment with non-steroidal anti-inflammatory drugs, antidepressants, anticonvulsants or opioids.
- Rejection of the patient
Trial locations and contacts
1 site in 1 country.
Paula Diéguez, Anesthesiologist contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Abente y Lago. Complejo Hospitalario Universitario A Coruña
A Coruña, 15006
Paula Diéguez, Anesthesiologist, pauladieguez@yahoo.com
Paula Diéguez, Anesthesiologist
About this study
Official title: Intercostal Nerves Block in the Midaxillary Line Versus Paravertebral Block, Ultrasound Guided Blocks for no Reconstructive Breast Surgery. Randomized Trial
The main objectives of the trial are the efficacy and safety of intercostal nerve block in the midaxillary line versus paravertebral block, both guided by ultrasound in patients scheduled for not reconstructive breast surgery.
- Conditions
- no Reconstructive Breast Surgery
- Being tested
- BRILMA, paravertebral block, dexketoprofen, paracetamol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRILMAProcedure or surgery
Also called intercostal nerves block in the midaxillary line
paravertebral blockProcedure or surgery
dexketoprofenDrug
paracetamolDrug
| Study group | Role | What they receive |
|---|---|---|
| BRILMA&dexketoprofen¶cetamol | Experimental | dexketoprofen: 50 mg/8h paracetamol: 1gr/6h Receives: Procedure: BRILMA; Drug: dexketoprofen; Drug: paracetamol |
| paravertebral block&dexketoprofen¶cetamol | Active comparator | dexketoprofen: 50 mg/8h paracetamol: 1g/6h Receives: Procedure: paravertebral block; Drug: dexketoprofen; Drug: paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score: verbal simple scale
admission to post-anesthesia care unit (PACU)
Measured: 0,3,6,12,18 and 24h
pain score: visual number scale
post-admission to PACU
Measured: 0, 3, 6,12, 18, 24h
opioid requirements
0 dose/ 1 dose/ 2 or more doses
Measured: 24 h
sleep quality
bad/regular/good
Measured: 24 h
amount of sleep
< 3h/ 3-6h, >6h
Measured: 24 h
Secondary outcomes (2)
percentage of participants with nausea and vomiting
without symptoms/ nausea/vomiting/ both symptoms
Measured: 24 hours
Number of Participants with Serious and Non-Serious Adverse Events
directly due to block nerve and general complications
Measured: 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for no Reconstructive Breast SurgeryStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paula Diéguez García
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paula Diéguez García, Complexo Hospitalario Universitario de A Coruña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018601
- Sponsor's protocol ID
- ProsMaMa 13.1
- Status last verified
- Jul 2019
- First submitted
- 10 Dec 2013
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intercostal Nerves Block in the Midaxillary Line Versus Paravertebral Block, Ultrasound Guided Blocks for no Reconstructive Breast Surgery. Randomized Trial
- ClinicalTrials.gov ID
- NCT02018601
- Acronym / sponsor ID
- ProsMaMa 13.1
- Conditions
- no Reconstructive Breast Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Paula Diéguez GarcíaUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 23 Dec 2013 (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 main objectives of the trial are the efficacy and safety of intercostal nerve block in the midaxillary line versus paravertebral block, both guided by ultrasound in patients scheduled for not reconstructive breast surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BRILMA&dexketoprofen¶cetamol | Experimental | Procedure: BRILMA, Drug: dexketoprofen, Drug: paracetamoldexketoprofen: 50 mg/8h paracetamol: 1gr/6h |
| paravertebral block&dexketoprofen¶cetamol | Active comparator | Procedure: paravertebral block, Drug: dexketoprofen, Drug: paracetamoldexketoprofen: 50 mg/8h paracetamol: 1g/6h |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients scheduled for not reconstructive unilateral breast surgery.
- Physical status American Society Anesthesiologists (ASA) I-III.
- Signed informed consent.
- Aged between 18 and 75 years.
- Ability to assess pain using a verbal and numerical scales.
Key exclusion criteria (11 listed)
- Personal history of disorders of hemostasis or previous history of abnormal bleeding evidence.
- Local infection at the site of the puncture or to puncture prior systemic.
- Contraindications to study medication.
- Muscle or neurological disease, peripheral or central.
- Patients with prior history of opioid.
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 |
|---|---|---|
| BRILMAAlso: intercostal nerves block in the midaxillary line | Procedure or surgery | BRILMA&dexketoprofen¶cetamol |
| paravertebral block | Procedure or surgery | paravertebral block&dexketoprofen¶cetamol |
| dexketoprofen | Drug | BRILMA&dexketoprofen¶cetamol, paravertebral block&dexketoprofen¶cetamol |
| paracetamol | Drug | BRILMA&dexketoprofen¶cetamol, paravertebral block&dexketoprofen¶cetamol |
Primary outcome
pain score: verbal simple scale
Time frame: 0,3,6,12,18 and 24h
admission to post-anesthesia care unit (PACU)
pain score: visual number scale
Time frame: 0, 3, 6,12, 18, 24h
post-admission to PACU
opioid requirements
Time frame: 24 h
0 dose/ 1 dose/ 2 or more doses
sleep quality
Time frame: 24 h
bad/regular/good
amount of sleep
Time frame: 24 h
< 3h/ 3-6h, >6h
2 secondary outcomes
percentage of participants with nausea and vomiting
Time frame: 24 hours
Number of Participants with Serious and Non-Serious Adverse Events
Time frame: 24 h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
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.
Paula Diéguez, Anesthesiologist contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing BRILMA, paravertebral block and dexketoprofen in people with no Reconstructive Breast Surgery, run by Paula Diéguez García at 1 site in Spain.
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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 31 Jul 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paula Diéguez, Anesthesiologist (pauladieguez@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain score: verbal simple scale (time frame: 0,3,6,12,18 and 24h). The study lists 5 primary outcomes in all. 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 31 Jul 2019.