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Completed

NCT Number: NCT06608810

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

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Inner Mongolia Baogang Hospital

Baotou, Inner Mongolia, 014010, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of breast fibromas

Exclusion criteria

  • heart attack mental disorder

Treatment and study plan

nerve block with 0.5% ropivacaine

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

Primary outcomes

  1. Changes in visual analog scale scores

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

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

Sponsors and collaborators

Lead sponsor

Inner Mongolia Baogang Hospital

Other

Registry information

Official study title

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

Acronym: PECS II

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 23, 2024
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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