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The Application of Pectoral Nerve II(PECS II)block in Breast Fibroadenoma Resection Surgery

Comparison of Efficacy in Pectoral Nerve Block Type II, Thoracic Paravertebral Block, and General Anesthesia Alone for Excision of Breast Fibroma: a Prospective Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06608810
Acronym
PECS II
Enrollment
90
Registered
2024-09-23
Start date
2023-07-30
Completion date
2024-06-01
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Brief summary

Patients were randomly assigned to the GA group, PECS II group, or TPVB group using a computer-generated random number table. Group assignments were kept in a sealed envelope, which was opened only after induction of general anesthesia on the day of surgery. This study was a double-blind trial, ensuring that neither the patients nor the investigators were aware of the analgesic method used. The same anesthesiologist was responsible for PECS II block or TPVB, while different anesthesiologists were responsible for anesthesia implementation and postoperative follow-up.

Detailed description

Written informed consent was obtained from all participants.90 female patients aged 18 to 65 with ASA I-II status were selected at Baogang Hospital, Inner Mongolia, who had been diagnosed with breast fibroadenomas. Exclusion criteria included pre-existing infection at the site of block, coagulation disorders, morbid obesity (body mass index > 40 kg/m²), allergy to local anesthetics, impaired lung function, significant cardiac disease, renal dysfunction, pre-existing neurological disorders, and psychiatric conditions.

Interventions

General anesthesia tracheal intubation was used. Induction was performed with midazolam 0.05ml/kg, etomidate 0.3-0.4mg/kg, sufentanil 0.3μg/kg-0.4μg/kg, and rocuronium bromide 0.8mg/kg, and after sufficient oxygen and denitration, the tracheal tube was placed by visual laryngoscopy, and the position of the tube was determined by auscultation of the lungs to determine the position of the catheter, and the respiratory sounds of the sides were symmetrically clear, so that the catheter was fixed and mechanical ventilation was performed. Anesthesia was maintained with remifentanil 0.1~0.3μg/(kg-min), propofol 2\ 4mg/(kg-h) rate microinfusion pump for continuous infusion. BIS was kept between 40\ 60. Intraoperative rocuronium bromide was given intermittently to maintain muscle relaxation. Perioperative fluid replacement followed the (4:2:1) rule in all patients. For maintenance of hemodynamic stability, ephedrine or atropine was administered, at the anesthesiologist's discretion, if verified a

Sponsors

Inner Mongolia Baogang Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Clinical diagnosis of breast fibromas

Exclusion criteria

* heart attack mental disorder

Design outcomes

Primary

MeasureTime frameDescription
Changes in visual analog scale scoresFrom enrollment to the end of treatment at 1 weekZero is equivalent to no pain and 10 indicates the worst possible pain."

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026