Comparative Evaluation of Pectoral Nerve Block Type II Versus Rhomboid Intercostal and Subserratus Plane Block in Breast Cancer Mastectomy for Postoperative Analgesia: a Randomized, Controlled Trial

Early Phase 1

Completed

• Conditions: Breast Cancer

• Registration Number: NCT06760429
• Lead Sponsor: Inner Mongolia Baogang Hospital

Brief Summary

This study aimed to investigate the analgesic effects of Pectoral Nerve Block Type II and Rhomboid Intercostal and Subserratus Plane Block after radical mastectomy for breast cancer.This prospective, double-blind, randomized controlled trial recruited 67 female patients with complete follow-up records who underwent unilateral modified radical mastectomy (MRM) at Inner Mongolia Baotou Steel Hospital from December 1, 2023 to December 1, 2024. Subjects were assigned to the observation group and the control group at a 1:1 ratio using a random number table. Among them, 30 patients who received pectoral nerve block (PECS II) for analgesia were included in the observation group, and 30 patients who received Rhomboid Intercostal and Subserratus (RISS) block for analgesia were included in the control group. The primary outcomes included the 40-item Quality of Recovery (QoR-40) scores at 6 hours and 24 hours after surgery, and the Visual Analogue Scale (VAS) pain scores in the Post-Anesthesia Care Unit (PACU), as well as at 2 hours, 6 hours, 12 hours, 24 hours, and 48 hours after surgery.T he secondary outcomes included the consumption of sufentanil in patient-controlled intravenous analgesia (PCIA) after surgery, the number of effective compressions, the use of remifentanil during the operation, the number of additional analgesic administrations, the sleep quality on the first day after surgery, and the incidences of block-related complications and postoperative adverse events.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-01
• Status Verified: 2024-12
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01
• Study First Submitted: 2025-01-03
• Study First Submitted QC: 2025-01-03
• Last Update Submitted: 2025-01-03
• Study First Posted: 2025-01-06
• Last Update Posted: 2025-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• patients met the diagnostic criteria of breast cancer;
• tolerance to surgery and anesthesia

Exclusion Criteria

• Patients with severe systemic diseases or anesthesia problems: Such patients were excluded to ensure safety and avoid the occurrence of irrelevant complications;
• Those with coagulation disorders;
• Patients with puncture contraindications or infections;
• Those allergic to local anesthetics;
• Those who refused to sign the informed consent form;
• Patients with cognitive or communication problems

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
visual analog scale	From PACU entry to 48 hours postoperatively

Trial Locations

Locations (1)

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