ClinicalTrials.gg
Not yet recruitingNCT07877740FASTBREAST2026Updated Oct 16, 2026

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

An observational study in Breast Cancer Surgery, Locoregional Anaesthesia and Hypnosis, sponsored by Hôpital Fribourgeois. Not yet recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by Hôpital Fribourgeois · Observational

Updated Oct 16, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
65
Ages
18 Years and older
Sex
All
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Study 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.

The main questions it aims to answer are:

  • 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
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Conditions studied

  • Breast Cancer Surgery
  • Locoregional Anaesthesia
  • Hypnosis
  • Fascial Plane Block

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03

In context

Breast Neoplasms

14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.

This study's planned enrollment of 65 is below the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Hôpital Fribourgeois is the lead sponsor of 18 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • to locoregional anesthesia (coagulopathy ( > 1.5, \< 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
65 participants (estimated)
Patient registry
No

Interventions

  • ProcedureStandardized locoregional anesthesia protocol for breast cancer 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.

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What researchers measure

Primary outcomes

  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.

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

Secondary outcomes

  1. Patient acceptance

    Proportion of eligible patients accepting the proposed locoregional anesthesia pathway.

    Time frame: Preoperative period (before surgery)

  2. Adherence to the standardized protocol

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

    Time frame: Periprocedural

  3. Anesthesia induction time

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

    Time frame: 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

    Time frame: 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.

    Time frame: Perioperative period (before hospital discharge)

  6. Perioperative complications

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

    Time frame: Perioperative period (from anesthesia start to hospital discharge)

  7. Reasons for conversion to general anesthesia

    Description of reasons leading to conversion, when applicable.

    Time frame: Intraoperative period

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Study locations

1 site
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References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2027; primary completion for Apr 2028, 15 months later.

Of 1,191 non-industry observational studies under Breast Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 139. This study's planned 15 months is below that.

Counting every sponsor, half of 1,380 studies reached it within 55 months; a quarter within 25 and three quarters within 126.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 14, 2026
First posted
Oct 16, 2026
StartEst.
Jan 1, 2027
Primary completionEst.
Apr 30, 2028
CompletionEst.
Apr 30, 2028
Last update
Oct 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 16, 2026
Show all 1 update
  1. Oct 16, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07877740
Lead sponsor
Hôpital Fribourgeois
Responsible party
Sponsor
First posted
Oct 16, 2026
Start date
Jan 1, 2027 (estimated)
Primary completion
Apr 30, 2028 (estimated)
Completion
Apr 30, 2028 (estimated)
Last update
Oct 16, 2026
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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