Ambulatory Plastic SurgeryPhase 3PECS B&BSNCT02682186
Pectoral Nerve Block for Analgesia After Breast Augmentation
A Phase 3 study testing Ropivacaine after dilution with sodium chloride 0.9% in people with Ambulatory Plastic Surgery and Esthetic Prosthetic Breast Expansion, run by University Hospital, Montpellier at 3 sites in France.
Trial summary
Breast augmentation is among the most popular surgical procedures performed in the world with approximately 1,773,584 performed in 2013. This surgical intervention generates important pains during postsurgical recovery. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Ambulatory Plastic Surgery, Esthetic Prosthetic Breast Expansion
- What is being tested?
- Ropivacaine after dilution with sodium chloride 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Feb 2016to 1 Jul 2020
- Phase
- Phase 3
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Affiliated to a national insurance scheme
- Having signed the informed consent for this study
- Score of American Society of Anesthesiology ( ASA) 1-3
- Be hospitalized in the ambulatory care unit (UCA) or plastic surgery service for a scheduled esthetic prosthetic breast expansion surgery.
Who cannot join
- Protected minor or major patients or in the incapacity to give his consent according to the article L1121-8 of the Code of the Health Public.
- Pregnant or breast-feeding women according to French law.
- Vulnerable people.
- Patients participating in another research
- Allergy with local anesthetics.
- Severe coagulopathy.
Show all 9Show fewer
- Chronic painful Patients (long-term treatment by analgesics)
- Contraindication to use analgesics of the protocol.
- Change of breast prostheses
Trial locations and contacts
3 sites in 1 country.
France3 sites
UH Montpellier - Hôpital Gui de Chauliac
Montpellier, 34295
UH Montpellier
Montpellier, 34295
CHU Nîmes
Nîmes, Nîmes, 30029
About this study
Official title: Effects of the Pectoral Blocks in the Prosthetic Breast Expansion Surgery : Prospective, Randomized, Double Blind Study.
Breast augmentation is among the most popular surgical procedures performed in the world with approximately 1,773,584 performed in 2013. This surgical intervention generates important pains during postsurgical recovery. A multimodal analgesia, based on the recommendations is proposed to the patients .The pectoral nerve block is an innovative technique of locoregional anesthesia that has already been successfully used in breast surgery. Its realization is fast, simple, and it would be superior compared with a paravertebral block within the framework of mastectomy. The interest of this technique has never been assessed in esthetic breast surgery. The aim of this study is to evaluate the analgesic efficacy of the association of " Pecs blocks 1 and 2 " on pain intensity after breast augmentation surgery.
Read the detailed description
The investigators hypothesized that the "Pecs blocks 1 and 2" will provide a decrease of the maximal pain of the first 6 post-operative hours after prosthetic breast expansion. The pain will be assessed according to a numerical scale. This prospective, randomized, double blind study will include 92 patients successively during two years, randomized into two arms : Pecs group and Control group, which will respectively have the block, and no block. The rest of the anesthesic and surgical care will be identical.
An intervention team (which will be different from the anesthesic team), will be alone with the patient for 15 minutes, and will realize or not the Pecs blocks according to the previous randomisation so that all caregivers taking in charge the patients as well as research observers will be blinded.
- Being tested
- Ropivacaine after dilution with sodium chloride 0.9%
- Keywords
- Prosthetic breast surgery, Locoregional anesthesia, Pectoral nerve block, Pain, Postoperative analgesia
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine after dilution with sodium chloride 0.9%Drug
After the anesthesic induction, the interventional team composed by at least a senior anaesthesiologist and a nurse anesthestic, will survey the patient and perform the Pecs blocks, whereas the anesthetic team is outside the room.
Realization of Pecs blocks 1 and 2 : the patient is in supine position with placing the upper limb in abduction position, a 100 mm needle is inserted under ultrasound using a linear US probe of high frequency after sheathing.
In the other group, sterilization, sheating and US are performed but the needle is not inserted.
| Study group | Role | What they receive |
|---|---|---|
| Control group (1) | No intervention | The PECS Blocks are not (1) performed. |
| PECS group (2) | Experimental | The PECS Blocks are performed (2): A single injection of Ropivacaine after dilution with sodium chloride 0.9% per fascial plane and per side. Receives: Drug: Ropivacaine after dilution with sodium chloride 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal value of pain intensity according to the numerical scale within the six first hours
Measured: up to First six postoperative hours
Secondary outcomes (2)
Maximal value of the pain at day 1 and until day 5
Value of pain according to a Numeric scale , recorded at day 1 in the hospital, and until day five by phone interview.
Measured: Five days
Morphinics side effects such as nausea / vomiting, constipation, pruritus; analgesic consumption, surgical complication, satisfaction questionaire
Any of side effect
Measured: Five days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study start1 Feb 2016
- Primary completion3 Oct 2019
- Study completion1 Jul 2020
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 Ambulatory Plastic 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gérald GC CHANQUES, MD, PhD, Study chair, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682186
- Sponsor's protocol ID
- 95832
- Other IDs
- 2015-002368-17, 2015
- Acronym
- PECS B&BS
- Status last verified
- Jul 2020
- First submitted
- 4 Feb 2016
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Aarab Y, Ramin S, Odonnat T, Garnier O, Boissin A, Molinari N, Marin G, Perrigault PF, Cuvillon P, Chanques G. Pectoral Nerve Blocks for Breast Augmentation Surgery: A Randomized, Double-blind, Dual-centered Controlled Trial. Anesthesiology. 2021 Sep 1;135(3):442-453. doi: 10.1097/ALN.0000000000003855.
PubMed 34195767
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Pectoral Blocks in the Prosthetic Breast Expansion Surgery : Prospective, Randomized, Double Blind Study.
- ClinicalTrials.gov ID
- NCT02682186
- Acronym / sponsor ID
- PECS B&BS / 95832
- Keywords
- Prosthetic breast surgery, Locoregional anesthesia, Pectoral nerve block, Pain, Postoperative analgesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 3 Oct 2019 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 15 Feb 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.
Breast augmentation is among the most popular surgical procedures performed in the world with approximately 1,773,584 performed in 2013. This surgical intervention generates important pains during postsurgical recovery. A multimodal analgesia, based on the recommendations is proposed to the patients .The pectoral nerve block is an innovative technique of locoregional anesthesia that has already been successfully used in breast surgery. Its realization is fast, simple, and it would be superior compared with a paravertebral block within the framework of mastectomy. The interest of this technique has never been assessed in esthetic breast surgery. The aim of this study is to evaluate the analgesic efficacy of the association of " Pecs blocks 1 and 2 " on pain intensity after breast augmentation surgery.
Detailed description
The investigators hypothesized that the "Pecs blocks 1 and 2" will provide a decrease of the maximal pain of the first 6 post-operative hours after prosthetic breast expansion. The pain will be assessed according to a numerical scale. This prospective, randomized, double blind study will include 92 patients successively during two years, randomized into two arms : Pecs group and Control group, which will respectively have the block, and no block. The rest of the anesthesic and surgical care will be identical.
An intervention team (which will be different from the anesthesic team), will be alone with the patient for 15 minutes, and will realize or not the Pecs blocks according to the previous randomisation so that all caregivers taking in charge the patients as well as research observers will be blinded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (1) | No intervention | –The PECS Blocks are not (1) performed. |
| PECS group (2) | Experimental | Drug: Ropivacaine after dilution with sodium chloride 0.9%The PECS Blocks are performed (2): A single injection of Ropivacaine after dilution with sodium chloride 0.9% per fascial plane and per side. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Affiliated to a national insurance scheme
- Having signed the informed consent for this study
- Score of American Society of Anesthesiology ( ASA) 1-3
- Be hospitalized in the ambulatory care unit (UCA) or plastic surgery service for a scheduled esthetic prosthetic breast expansion surgery.
Key exclusion criteria (9 listed)
- Protected minor or major patients or in the incapacity to give his consent according to the article L1121-8 of the Code of the Health Public.
- Pregnant or breast-feeding women according to French law.
- Vulnerable people.
- Patients participating in another research
- Allergy with local anesthetics.
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 |
|---|---|---|
| Ropivacaine after dilution with sodium chloride 0.9%After the anesthesic induction, the interventional team composed by at least a senior anaesthesiologist and a nurse anesthestic, will survey the patient and perform the Pecs blocks, whereas the anesthetic team is outside the room. Realization of Pecs blocks 1 and 2 : the patient is in supine position with placing the upper limb in abduction position, a 100 mm needle is inserted under ultrasound using a linear US probe of high frequency after sheathing. In the other group, sterilization, sheating and US are performed but the needle is not inserted. | Drug | PECS group (2) |
Primary outcome
Maximal value of pain intensity according to the numerical scale within the six first hours
Time frame: up to First six postoperative hours
2 secondary outcomes
Maximal value of the pain at day 1 and until day 5
Time frame: Five days
Morphinics side effects such as nausea / vomiting, constipation, pruritus; analgesic consumption, surgical complication, satisfaction questionaire
Time frame: Five 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 12 Jun 2026.
- Results publication: PubMed 34195767Aarab Y, Ramin S, Odonnat T, Garnier O, Boissin A, Molinari N, Marin G, Perrigault PF, Cuvillon P, Chanques G. Pectoral Nerve Blocks for Breast Augmentation Surgery: A Randomized, Double-blind, Dual-centered Controlled Trial. Anesthesiology. 2021 Sep 1;135(3):442-453. doi: 10.1097/ALN.0000000000003855.
- Individual participant dataSharing planned: Undecided
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.
Gérald GC CHANQUES, MD, PhD study chair
University Hospital, Montpellier
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ropivacaine after dilution with sodium chloride 0.9% in people with Ambulatory Plastic Surgery and Esthetic Prosthetic Breast Expansion, run by University Hospital, Montpellier at 3 sites 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 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: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Maximal value of pain intensity according to the numerical scale within the six first hours (time frame: up to First six postoperative hours). 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 NCT02682186, 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 12 Jun 2026.