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

NCT ID: NCT06608810

Last Updated: 2024-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-30

Study Completion Date

2024-06-01

Brief Summary

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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

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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.

Conditions

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Breast Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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

Group Type OTHER

nerve block with 0.5% ropivacaine

Intervention Type DRUG

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

Interventions

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nerve 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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of breast fibromas

Exclusion Criteria

* heart attack mental disorder
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Inner Mongolia Baogang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Inner Mongolia Baogang Hospital

Baotou, Inner Mongolia, China

Site Status

Countries

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China

Other Identifiers

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2024-MER-069

Identifier Type: -

Identifier Source: org_study_id

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