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

Not Applicable

Completed

• Conditions: Breast Neoplasms
• Interventions: Drug: nerve block with 0.5% ropivacaine

• Registration Number: NCT06608810
• Lead Sponsor: Inner Mongolia Baogang Hospital

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.

Study Timeline

• Study Start: 2023-07-30
• Primary Completion: 2024-05-30
• Study Completion: 2024-06-01
• Status Verified: 2024-09
• Study First Submitted: 2024-09-18
• Study First Submitted QC: 2024-09-20
• Last Update Submitted: 2024-09-20
• Study First Posted: 2024-09-23
• Last Update Posted: 2024-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• Clinical diagnosis of breast fibromas

Exclusion Criteria

• heart attack mental disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Comparison of efficacy in pectoral nerve block type II, thoracic paravertebral block, and general an	nerve block with 0.5% ropivacaine	-

Primary Outcome Measures

Name	Time	Method
Changes in visual analog scale scores	From enrollment to the end of treatment at 1 week	Zero is equivalent to no pain and 10 indicates the worst possible pain.\"

Trial Locations

Locations (1)

Inner Mongolia Baogang Hospital; 🇨🇳 Baotou, Inner Mongolia, China