BreastcancerPECSNCT03023007
Study Evaluating the Efficacy of Loco-regional Anaesthesia PECS on Chronic Pain of a Mastectomy
A study testing Loco-regional anaesthesia in people with Breastcancer and Mastectomy, run by Centre Oscar Lambret at 1 site in France.
Trial summary
A non-randomized, mono-centric, prospective interventional study that will assess the efficacy of the loco-regional anesthesia PECS on the rate of chronic pain, 6 month after a patient will have either received a mastectomy or a mastectomy associated with axillary nodes dissection, and/or a reconstruction by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breastcancer, Mastectomy
- What is being tested?
- Loco-regional anaesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2017to 27 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with unilateral breast cancer
- Surgery must be a total mastectomy +/- axillary lymph node dissection and +/- reconstruction by prosthesis; unless first surgery was performed more than 5 years prior to total mastectomy without any residual pain
- Age ≥ 18 ans
- Non-opposition of patients
Who cannot join
- Reconstruction by other than prosthesis
- Previous breast surgery in the last year
- Hypersensitivity or allergy of anaesthetics
- Coagulopathy and local infections
- Pregnant or breastfeeding
- Patients under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study Evaluating the Efficacy of Loco-regional Anaesthesia PECS on the Rate of Chronic Pains 6 Month After a Mastectomy Associated or Not With Axillary Node Dissection and/or a Reconstruction Prosthesis.
A non-randomized, mono-centric, prospective interventional study that will assess the efficacy of the loco-regional anesthesia PECS on the rate of chronic pain, 6 month after a patient will have either received a mastectomy or a mastectomy associated with axillary nodes dissection, and/or a reconstruction by prosthesis.
Read the detailed description
The aim of this study is to assess the care given to treat breast cancer while the patient receives a total mastectomy. It is done by evaluating the technique of anesthesia PECS used during this procedure so that the rate of chronic pain can be measured 6 month after the operation.
As well as total mastectomy, patients are also eligible for an axillary lymph node dissection (ALND) and a reconstruction of the breast by prosthesis as options.
Other objectives of the study include:
- Evaluating the effectiveness of the PECS anesthesia technique on the trajectory of acute post-operative pain and on chronic pain after 12 month of the surgery
- Evaluating the type and intensity of the pain
- Evaluating the quality of life
- Study the link between chronic pain and the trajectory of acute pain.
- Conditions
- Breastcancer, Mastectomy
- Being tested
- Loco-regional anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loco-regional anaesthesiaProcedure or surgery
Loco-regional anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| Loco-regional anaesthesia | Experimental | Loco-regional anaesthesia Anesthesia technique used : loco-regional PECS for patients requiring Mastectomy; And/or Axillary node dissection ; And/or Reconstruction of breast by prosthesis Receives: Procedure: Loco-regional anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of chronic pain
The rate of chronic pain will be assessed in percentage (%) based on the criteria of the International Association for the Study Pain (IASP) during an algology medical consultation.
Measured: 6 month after surgery
Secondary outcomes (9)
Acute post-operative pain
A representation of the trajectory of pain in the 3 days will be drawn. This pain trajectory is defined as the kinetics of the average daily visual analog scale (VAS) score for 3 days.
Measured: During the 3 days following the surgery
Side effects post-operative
All side effects (e.g. nausea, vomiting etc.) will be recorded, with its date, time, severity, relation with the treatment, treatment associated and evolution. The intensity of adverse events will be scored using the criteria from NCI-CTCAE version 4.0.
Measured: During the 3 days following the surgery
Rate of chronic pain
Assessed based on the criteria of the International Association for the Study Pain (IASP) collected via telephone call.
Measured: 12 month after the surgery
Type of chronic pain
The type of chronic pain will be determined using the DN4 score. The DN4 score is a form used for the diagnostic of neuropathic pain.
Measured: 6 and 12 month after surgery
Intensity of chronic pain
The intensity of the pain will be recorded using the visual analog scale (VAS).
Measured: 6 and 12 month after surgery
predictive factors of survival
Using the proportional hazards model.
Measured: an average of 1 year
Quality of life of the patient assessed with the QLQ-C30 questionnaire
QLQ-C30 from the EORTC (quality of life in general, physical condition, limitations to activities, cognitive functions, emotional and social and symptoms occurrences related to cancer or the treatment)
Measured: an average of 1 year
Quality of life of the patient assessed with the QLQ-BR23 questionnaire
QLQ-BR23 (body image, perception of the future etc. and side effects)
Measured: an average of 1 year
Depression assessed with the HADS questionnaire
HADS (Hospital Anxiety and Depression Scale) : to detect anxiety and depression
Measured: an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study start3 Apr 2017
- Primary completion22 Feb 2019
- Study completion27 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastcancerStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abesse AHMEIDI, MD, Study director, Département Anesthésie /Algologie, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023007
- Sponsor's protocol ID
- PECS-1601
- Other IDs
- N°IdRCB : N°2016-A00562-49
- Acronym
- PECS
- Status last verified
- Sep 2026
- First submitted
- 10 Jan 2017
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garcia V, Wallet J, Leroux-Bromberg N, Delbrouck D, Hannebicque K, Ben Oune F, Leguillette C, Le Deley MC, Ahmeidi A. Incidence and characteristics of chronic postsurgical pain at 6 months after total mastectomy under pectoserratus and interpectoral plane block combined with general anesthesia: a prospective cohort study. Reg Anesth Pain Med. 2024 Jan 11;49(1):36-40. doi: 10.1136/rapm-2022-104185.
PubMed 37280082
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Evaluating the Efficacy of Loco-regional Anaesthesia PECS on the Rate of Chronic Pains 6 Month After a Mastectomy Associated or Not With Axillary Node Dissection and/or a Reconstruction Prosthesis.
- ClinicalTrials.gov ID
- NCT03023007
- Acronym / sponsor ID
- PECS / PECS-1601
- Conditions
- Breastcancer, Mastectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 22 Feb 2019 (actual)
- Study completion
- 27 Aug 2019 (actual)
- First posted
- 18 Jan 2017 (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.
A non-randomized, mono-centric, prospective interventional study that will assess the efficacy of the loco-regional anesthesia PECS on the rate of chronic pain, 6 month after a patient will have either received a mastectomy or a mastectomy associated with axillary nodes dissection, and/or a reconstruction by prosthesis.
Detailed description
The aim of this study is to assess the care given to treat breast cancer while the patient receives a total mastectomy. It is done by evaluating the technique of anesthesia PECS used during this procedure so that the rate of chronic pain can be measured 6 month after the operation.
As well as total mastectomy, patients are also eligible for an axillary lymph node dissection (ALND) and a reconstruction of the breast by prosthesis as options.
Other objectives of the study include:
- Evaluating the effectiveness of the PECS anesthesia technique on the trajectory of acute post-operative pain and on chronic pain after 12 month of the surgery
- Evaluating the type and intensity of the pain
- Evaluating the quality of life
- Study the link between chronic pain and the trajectory of acute pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Loco-regional anaesthesia | Experimental | Procedure: Loco-regional anaesthesiaLoco-regional anaesthesia Anesthesia technique used : loco-regional PECS for patients requiring Mastectomy; And/or Axillary node dissection ; And/or Reconstruction of breast by prosthesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with unilateral breast cancer
- Surgery must be a total mastectomy +/- axillary lymph node dissection and +/- reconstruction by prosthesis; unless first surgery was performed more than 5 years prior to total mastectomy without any residual pain
- Age ≥ 18 ans
- Non-opposition of patients
Key exclusion criteria (6 listed)
- Reconstruction by other than prosthesis
- Previous breast surgery in the last year
- Hypersensitivity or allergy of anaesthetics
- Coagulopathy and local infections
- Pregnant or breastfeeding
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 |
|---|---|---|
| Loco-regional anaesthesiaLoco-regional anaesthesia | Procedure or surgery | Loco-regional anaesthesia |
Primary outcome
Rate of chronic pain
Time frame: 6 month after surgery
The rate of chronic pain will be assessed in percentage (%) based on the criteria of the International Association for the Study Pain (IASP) during an algology medical consultation.
9 secondary outcomes
Acute post-operative pain
Time frame: During the 3 days following the surgery
Side effects post-operative
Time frame: During the 3 days following the surgery
Rate of chronic pain
Time frame: 12 month after the surgery
Type of chronic pain
Time frame: 6 and 12 month after surgery
Intensity of chronic pain
Time frame: 6 and 12 month after surgery
predictive factors of survival
Time frame: an average of 1 year
Quality of life of the patient assessed with the QLQ-C30 questionnaire
Time frame: an average of 1 year
Quality of life of the patient assessed with the QLQ-BR23 questionnaire
Time frame: an average of 1 year
Depression assessed with the HADS questionnaire
Time frame: an average of 1 year
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 17 Sep 2026.
- Derived from this study: PubMed 37280082Garcia V, Wallet J, Leroux-Bromberg N, Delbrouck D, Hannebicque K, Ben Oune F, Leguillette C, Le Deley MC, Ahmeidi A. Incidence and characteristics of chronic postsurgical pain at 6 months after total mastectomy under pectoserratus and interpectoral plane block combined with general anesthesia: a prospective cohort study. Reg Anesth Pain Med. 2024 Jan 11;49(1):36-40. doi: 10.1136/rapm-2022-104185.
- 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.
Abesse AHMEIDI, MD study director
Département Anesthésie /Algologie, Centre Oscar Lambret
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Loco-regional anaesthesia in people with Breastcancer and Mastectomy, run by Centre Oscar Lambret 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 4 inclusion and 6 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 17 Sep 2026. 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?
Rate of chronic pain (time frame: 6 month after surgery). 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 NCT03023007, which also lists 1 linked publication.
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 17 Sep 2026.