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AzTrials

Breast Cancer SurgeryFASTBREAST2026NCT07877740

Feasibility of a Standardized Fascial Plane Block Protocol for Breast Cancer Surgery

An observational study of Breast Cancer Surgery and Locoregional Anaesthesia, run by Hôpital Fribourgeois at 1 site in Switzerland.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this observational study is to evaluate the feasibility of a standardized locoregional anesthesia protocol for patients undergoing breast cancer surgery under procedural sedation or adjunctive hypnosis. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Standardized locoregional anesthesia protocol for breast cancer surgery
Type of treatment
Surgery or procedure
How many people
65 participants
Where
1 siteSwitzerland
Study dates
1 Jan 2027to 30 Apr 2028
Phase
Observational
Are there results?
Not yet: the study is under way

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

Study population: The study population will consist of adult patients scheduled for unilateral breast cancer surgery at HFR Fribourg during the study period.

Who may be able to join

  • Age ≥ 18 years
  • Scheduled for elective unilateral breast cancer surgery (e.g. lumpectomy or mastectomy with or without sentinel lymph node biopsy or axillary dissection)

Who cannot join

  • Contraindications to locoregional anesthesia (coagulopathy (INR > 1.5, thrombocytes < 80 000/mm³), infection at puncture site, allergy to local anesthetics)
  • Inability to cooperate with the procedure (e.g. major language barrier, severe uncontrolled psychiatric disorder or severe cognitive impairment)
  • Pregnancy

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Switzerland1 site

  • Hôpital Fribourgeois

    Fribourg

    Corinne Grandjean, +41 26 306 33 10, sam-anesthesie-fri@h-fr.ch

    Pauline Hämmerli, pauline.haemmerli@h-fr.ch

Other trials in Switzerland

About this study

Official title: Feasibility of a Standardized Fascial Plane Block Protocol for Breast Cancer Surgery Under Locoregional Anesthesia; a Prospective Study

The goal of this observational study is to evaluate the feasibility of a standardized locoregional anesthesia protocol for patients undergoing breast cancer surgery under procedural sedation or adjunctive hypnosis.

The main questions it aims to answer are:

Read more
  • Can breast cancer surgery be successfully completed using this standardized anesthetic protocol without conversion to general anesthesia?
  • Is this standardized protocol feasible to implement in routine clinical practice, based on patient acceptance, protocol adherence, anesthesia induction time, patient and surgeon satisfaction, perioperative complications, and reasons for conversion to general anesthesia?

Participants will:

  • receive the standardized locoregional anesthesia protocol, combined with either procedural sedation or adjunctive hypnosis, as part of their routine clinical care;
  • allow the research team to collect information from their medical records regarding the anesthesia and surgical procedure;
  • complete a short satisfaction questionnaire before hospital discharge
Being tested
Standardized locoregional anesthesia protocol for breast cancer surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standardized locoregional anesthesia protocol for breast cancer surgeryProcedure or surgery

    Participants receive a standardized locoregional anesthesia protocol consisting of predefined ultrasound-guided fascial plane blocks for breast cancer surgery, combined with either procedural sedation or adjunctive hypnosis, according to routine clinical practice at the study institution.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Successful completion of surgery without conversion to general anesthesia

    Proportion of participants in whom surgery is completed under locoregional anesthesia without conversion to general anesthesia requiring airway instrumentation.

    Measured: Intraoperative period (from surgical incision to end of surgery)

Secondary outcomes (7)

  1. Patient acceptance

    Proportion of eligible patients accepting the proposed locoregional anesthesia pathway.

    Measured: Preoperative period (before surgery)

  2. Adherence to the standardized protocol

    Proportion of enrolled participants in whom the standardized protocol is applied as planned.

    Measured: Periprocedural

  3. Anesthesia induction time

    Time from participant arrival in the operating room to surgical incision.

    Measured: Periprocedural (before surgical incision)

  4. Surgeon satisfaction

    Surgeon satisfaction with operative conditions assessed using a 5-point Likert satisfaction scale, ranging from 1 (very dissatisfied) to 5 (very satisfied), with higher scores indicating greater satisfaction

    Measured: Intraoperative period (immediately after surgery)

  5. Patient satisfaction

    Patient satisfaction with anesthetic management assessed using a 5-point Likert satisfaction scale, ranging from 1 (very dissatisfied) to 5 (very satisfied), with higher scores indicating greater satisfaction.

    Measured: Perioperative period (before hospital discharge)

  6. Perioperative complications

    Incidence of complications related to locoregional anesthesia, sedation, hypnosis, or conversion to general anesthesia.

    Measured: Perioperative period (from anesthesia start to hospital discharge)

  7. Reasons for conversion to general anesthesia

    Description of reasons leading to conversion, when applicable.

    Measured: Intraoperative period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2026
  2. Study start1 Jan 2027 (estimated)
  3. Primary completion30 Apr 2028 (estimated)
  4. Study completion30 Apr 2028 (estimated)

Resources

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
65 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07877740
Sponsor's protocol ID
FAST-BREAST-2026
Acronym
FASTBREAST2026
Status last verified
Oct 2026
First submitted
14 Jul 2026
Last updated
16 Oct 2026
Results posted
No
Individual data sharing
No

Publications

  • Zeng J, Wang L, Cai Q, Wu J, Zhou C. Effect of hypnosis before general anesthesia on postoperative outcomes in patients undergoing minor surgery for breast cancer: a systematic review and meta-analysis. Gland Surg. 2022 Mar;11(3):588-598. doi: 10.21037/gs-22-114.

    PubMed 35402208

  • Lacroix C, Duhoux FP, Bettendorff J, Watremez C, Roelants F, Docquier MA, Potie A, Coyette M, Gerday A, Samartzi V, Piette P, Piette N, Berliere M. Impact of Perioperative Hypnosedation on Postmastectomy Chronic Pain: Preliminary Results. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419869494. doi: 10.1177/1534735419869494.

    PubMed 31441331

  • Cramer H, Lauche R, Paul A, Langhorst J, Kummel S, Dobos GJ. Hypnosis in breast cancer care: a systematic review of randomized controlled trials. Integr Cancer Ther. 2015 Jan;14(1):5-15. doi: 10.1177/1534735414550035. Epub 2014 Sep 18.

    PubMed 25233905

  • An R, Wang D, Liang XL, Chen Q, Pang QY, Liu HL. The postoperative analgesic efficacy of different regional anesthesia techniques in breast cancer surgery: A network meta-analysis. Front Oncol. 2023 Mar 28;13:1083000. doi: 10.3389/fonc.2023.1083000. eCollection 2023.

    PubMed 37056343

  • Ling D, Wei S, Wang S, Wang P, He Z, Hu Z, Yu S, Wu Y, Wang B, Zhang J, Xu J. Recovery quality with regional anesthesia and dexmedetomidine sedation versus general anesthesia for ambulatory breast cancer surgery: A randomized trial. Breast. 2026 Jun;87:104776. doi: 10.1016/j.breast.2026.104776. Epub 2026 Mar 23.

    PubMed 41932294

  • Garg R, Bhan S, Vig S. Newer regional analgesia interventions (fascial plane blocks) for breast surgeries: Review of literature. Indian J Anaesth. 2018 Apr;62(4):254-262. doi: 10.4103/ija.IJA_46_18.

    PubMed 29720750

  • Vanni G, Costanzo G, Pellicciaro M, Materazzo M, Buonomo C, Federico T, Giacobbi E, Servadei F, Anemona L, Noce A, Dauri M, Buonomo OC. Awake Breast Surgery: A Systematic Review. In Vivo. 2023 Jul-Aug;37(4):1412-1422. doi: 10.21873/invivo.13225.

    PubMed 37369489

  • Ertas G, Cakmak HS, Ocak S, Yilmaz M, Ozdemir DB, Tulgar S. Is the combination of interfascial plane blocks sufficient for awake breast cancer surgery? An observational, prospective, proof-of-concept study. BMC Anesthesiol. 2024 Sep 20;24(1):337. doi: 10.1186/s12871-024-02725-0.

    PubMed 39304815

  • Hamilton DL, Pawa A. Anaesthesia for awake breast surgery. BJA Educ. 2022 Dec;22(12):452-455. doi: 10.1016/j.bjae.2022.08.003. Epub 2022 Oct 2. No abstract available.

    PubMed 36406039

  • Chin KJ, Versyck B, Pawa A. Ultrasound-guided fascial plane blocks of the chest wall: a state-of-the-art review. Anaesthesia. 2021 Jan;76 Suppl 1:110-126. doi: 10.1111/anae.15276.

    PubMed 33426660

  • Joshi GP, Mariano ER, Elkassabany NM, Harbell M, Johnson RL, Li J, Napolitano L, Schwartz G, Suresh S, Wyatt-Thompson KE, Burns A, Agarkar M, Marbella A, Ramirez S, Sullivan N, Bloschichak A, Uhl S, Domino KB. 2026 American Society of Anesthesiologists Practice Guideline on Perioperative Pain Management Using Local and Regional Analgesia for Cardiothoracic Surgeries, Mastectomy, and Abdominal Surgeries. Anesthesiology. 2026 Jan 1;144(1):19-43. doi: 10.1097/ALN.0000000000005790. Epub 2025 Dec 9.

    PubMed 41363869

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer Surgery and Locoregional Anaesthesia, run by Hôpital Fribourgeois at 1 site in Switzerland.

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 2 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: opening soon, as of the sponsor's last update on 16 Oct 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 Switzerland. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successful completion of surgery without conversion to general anesthesia (time frame: Intraoperative period (from surgical incision to end of 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 NCT07877740, which also lists 11 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 16 Oct 2026.

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