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CompletedNCT06608810PECS IIUpdated Sep 23, 2024

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

An interventional study of nerve block with 0.5% ropivacaine in Breast Neoplasms, sponsored by Inner Mongolia Baogang Hospital. Completed at 1 site in China. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-09-23.

Sponsored by Inner Mongolia Baogang Hospital · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Jul 2023, registered Sep 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
Female
01

Study 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.

Read the 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.

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Conditions studied

  • Breast Neoplasms

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03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 90 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Inner Mongolia Baogang Hospital is the lead sponsor of 5 studies on the registry; 2 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 to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Clinical diagnosis of breast fibromas

Exclusion criteria

Exclusion Criteria:

  • heart attack mental disorder
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • Other
    Comparison of efficacy in pectoral nerve block type II, thoracic paravertebral block, and general an

    Drug: nerve block with 0.5% ropivacaine

Interventions

  • Drugnerve block with 0.5% ropivacaine

    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

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What researchers measure

Primary outcomes

  1. Changes in visual analog scale scores

    Zero is equivalent to no pain and 10 indicates the worst possible pain.\"

    Time frame: From enrollment to the end of treatment at 1 week

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Study locations

1 site
  • Inner Mongolia Baogang Hospital
    Baotou, Inner Mongolia 014010, China
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References and documents

Individual participant data

Plan to share: No — Research data is not shared for the protection of subjects

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06608810
Lead sponsor
Inner Mongolia Baogang Hospital
Responsible party
Sponsor
First posted
Sep 23, 2024
Start date
Jul 30, 2023
Primary completion
May 30, 2024
Completion
Jun 1, 2024
Last update
Sep 23, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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