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

NCT06608810 | Completed

• 1 other identifier: 2024-MER-069
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• Changes in visual analog scale scores

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

  From enrollment to the end of treatment at 1 week

Study Arms (1)

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

OTHER

Drug: nerve block with 0.5% ropivacaine

Interventions

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

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of breast fibromas

You may not qualify if:

• heart attack mental disorder

Sponsors & Collaborators

• Inner Mongolia Baogang Hospital: lead

Study Sites (1)

Inner Mongolia Baogang Hospital

Baotou, Inner Mongolia, 014010, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Nerve Block; Ropivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 23, 2024
• Study Start: July 30, 2023
• Primary Completion: May 30, 2024
• Study Completion: June 1, 2024
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)