Breast/SurgeryNCT02838173
Serratus Plane Block for the Prevention of Chronic Pain After Breast Cancer Surgery
A study testing serratus plane bloc : Ropivacaine 2mg/ml (0,3ml/kg) and tissue infiltration : Ropivacaine 2mg/ml (0,3ml/kg) in people with Breast/Surgery and Postoperative Complication, run by Erasme University Hospital.
Trial summary
This study compare the "Serratus block plane" (SPB) and the local infiltration of the tissue in the prevention of acute and chronic pain after breast cancer surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast/Surgery, Postoperative Complication, Chronic Pain
- What is being tested?
- serratus plane bloc : Ropivacaine 2mg/ml (0,3ml/kg) and tissue infiltration : Ropivacaine 2mg/ml (0,3ml/kg)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Mar 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women scheduled for elective breast neoplasm surgery
- Of ASA classification 1, 2 or 3
- Patients who provide written informed consent
Who cannot join
- Minor patients
- Patients refusing to sign the consent
- Patients included in another protocol within 3 months
- Pregnant or lactating patients
- Patients with history of allergy to local anesthetics (Ropivacaine)
- Patients with contraindication to regional anesthesia (coagulopathy, local infection ...)
Show all 9Show fewer
- Patients with history of prior breast surgery (excluding diagnostic biopsy)
- Patients with history of chronic pain
- Patients with a history of psychiatric disorder
Trial locations and contacts
No sites are listed yet.
Wendy Villareal Fernandez, MD contact
About this study
This study compare the "Serratus block plane" (SPB) and the local infiltration of the tissue in the prevention of acute and chronic pain after breast cancer surgery.
Read the detailed description
Chronic pain after breast surgery may be severe, often requiring the use of morphine. The incidence of chronic pain varies from 27 to 50% depending on definitions.
The infiltration of tissues by a local anesthetic is a simple, fast and low risk technique but of limited effectiveness.
Serratus the flat block, performed under ultrasound guidance, is minimally invasive and easy to perform. It allows anesthesia and analgesia to an extended part of the anterolateral chest wall and the axilla. This regional anesthesia technique provides good analgesia during and after breast surgery, but remains to be evaluated; beyond perioperative analgesia, the benefit-risk, post operative rehabilitation, and the impact on ambulatory and on chronic pain are fundamental objectives.
- Conditions
- Breast/Surgery, Postoperative Complication, Chronic Pain
- Being tested
- serratus plane bloc : Ropivacaine 2mg/ml (0,3ml/kg), tissue infiltration : Ropivacaine 2mg/ml (0,3ml/kg), serratus plane bloc : placebo, tissue infiltration : placebo
- Medical subject headings
- Postoperative Complications, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serratus plane bloc : Ropivacaine 2mg/ml (0,3ml/kg)Procedure or surgery
tissue infiltration : Ropivacaine 2mg/ml (0,3ml/kg)Procedure or surgery
serratus plane bloc : placeboProcedure or surgery
tissue infiltration : placeboProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| SPB | Experimental | Serratus Plane Bloc with Ropivacaine 2mg/ml (0,3ml/kg) and tissue infiltration with placebo made once, by the anesthetist in the operating theater before surgical incision Receives: Procedure: serratus plane bloc : Ropivacaine 2mg/ml (0,3ml/kg); Procedure: tissue infiltration : placebo |
| tissue infiltration | Active comparator | tissue infiltration with Ropivacaine 2mg/ml (0,3ml/kg) and Serratus Plane Bloc with placebo made once, by the anesthetist in the operating theater before surgical incision Receives: Procedure: tissue infiltration : Ropivacaine 2mg/ml (0,3ml/kg); Procedure: serratus plane bloc : placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative chronic pain assessed using the DN4 questionnaire
DN4 questionnaire
Measured: 3 months postoperative
Secondary outcomes (2)
postoperative acute pain
Visual analogue scale (V.A.S.)
Measured: day 1, day 2, day 3 postoperative
morphine consumption
Measured: day 1, day 2, day 3 postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Céline Boudart, Erasme University Hospital
- Investigators
- Luc Van Obbergh, MD PhD, Study director, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838173
- Sponsor's protocol ID
- B406201628750
- Status last verified
- Jun 2016
- First submitted
- 30 Jun 2016
- Last updated
- 20 Jul 2016
- Results posted
- No
Publications
Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.
PubMed 23923989Andreae MH, Andreae DA. Regional anaesthesia to prevent chronic pain after surgery: a Cochrane systematic review and meta-analysis. Br J Anaesth. 2013 Nov;111(5):711-20. doi: 10.1093/bja/aet213. Epub 2013 Jun 28.
PubMed 23811426
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serratus Plane Block for the Prevention of Chronic Pain After Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT02838173
- Acronym / sponsor ID
- B406201628750
- Conditions
- Breast/Surgery, Postoperative Complication, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 20 Jul 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.
This study compare the "Serratus block plane" (SPB) and the local infiltration of the tissue in the prevention of acute and chronic pain after breast cancer surgery.
Detailed description
Chronic pain after breast surgery may be severe, often requiring the use of morphine. The incidence of chronic pain varies from 27 to 50% depending on definitions.
The infiltration of tissues by a local anesthetic is a simple, fast and low risk technique but of limited effectiveness.
Serratus the flat block, performed under ultrasound guidance, is minimally invasive and easy to perform. It allows anesthesia and analgesia to an extended part of the anterolateral chest wall and the axilla. This regional anesthesia technique provides good analgesia during and after breast surgery, but remains to be evaluated; beyond perioperative analgesia, the benefit-risk, post operative rehabilitation, and the impact on ambulatory and on chronic pain are fundamental objectives.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPB | Experimental | Procedure: serratus plane bloc : Ropivacaine 2mg/ml (0,3ml/kg), Procedure: tissue infiltration : placeboSerratus Plane Bloc with Ropivacaine 2mg/ml (0,3ml/kg) and tissue infiltration with placebo made once, by the anesthetist in the operating theater before surgical incision |
| tissue infiltration | Active comparator | Procedure: tissue infiltration : Ropivacaine 2mg/ml (0,3ml/kg), Procedure: serratus plane bloc : placebotissue infiltration with Ropivacaine 2mg/ml (0,3ml/kg) and Serratus Plane Bloc with placebo made once, by the anesthetist in the operating theater before surgical incision |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women scheduled for elective breast neoplasm surgery
- Of ASA classification 1, 2 or 3
- Patients who provide written informed consent
Key exclusion criteria (9 listed)
- Minor patients
- Patients refusing to sign the consent
- Patients included in another protocol within 3 months
- Pregnant or lactating patients
- Patients with history of allergy to local anesthetics (Ropivacaine)
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 |
|---|---|---|
| serratus plane bloc : Ropivacaine 2mg/ml (0,3ml/kg) | Procedure or surgery | SPB |
| tissue infiltration : Ropivacaine 2mg/ml (0,3ml/kg) | Procedure or surgery | tissue infiltration |
| serratus plane bloc : placebo | Procedure or surgery | tissue infiltration |
| tissue infiltration : placebo | Procedure or surgery | SPB |
Primary outcome
postoperative chronic pain assessed using the DN4 questionnaire
Time frame: 3 months postoperative
DN4 questionnaire
2 secondary outcomes
postoperative acute pain
Time frame: day 1, day 2, day 3 postoperative
morphine consumption
Time frame: day 1, day 2, day 3 postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
- Background: PubMed 23923989Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.
- Background: PubMed 23811426Andreae MH, Andreae DA. Regional anaesthesia to prevent chronic pain after surgery: a Cochrane systematic review and meta-analysis. Br J Anaesth. 2013 Nov;111(5):711-20. doi: 10.1093/bja/aet213. Epub 2013 Jun 28.
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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.
Wendy Villareal Fernandez, MD contact
Luc Van Obbergh, MD PhD study director
Erasme University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing serratus plane bloc : Ropivacaine 2mg/ml (0,3ml/kg) and tissue infiltration : Ropivacaine 2mg/ml (0,3ml/kg) in people with Breast/Surgery and Postoperative Complication, run by Erasme University Hospital.
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 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: status not confirmed, as of the sponsor's last update on 20 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Céline Boudart, MD (3225553919, cboudart@ulb.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative chronic pain assessed using the DN4 questionnaire (time frame: 3 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02838173, which also lists 2 linked publications.
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 20 Jul 2016.