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

Inner Mongolia Baogang Hospital

Status and phase: Completed; Early Phase 1

Conditions: Breast Cancer

Treatments: Procedure: Subserratus Plane Block; Procedure: Pectoral Nerve Block Type II

Study type: Interventional

Funder types: Other

Identifiers

NCT06760429

2024-MER-302

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Subserratus Plane Block

Experimental group

Description:

Once the needle tip reached the fascial plane between the pectoralis minor and serratus anterior muscles and there was no blood aspiration, 15 mL of 0.375% ropivacaine was injected. Then the needle was withdrawn until the needle tip reached the fascial plane between the pectoralis major and pectoralis minor muscles, and another 15 mL of 0.375% ropivacaine was injected. After the nerve block was implemented, the area of sensory block was marked, and the spread of the local anesthetic was monitored by ultrasound. Alcohol swabs and pinprick tests were used to detect cold and pain sensations.

Treatment:

Procedure: Subserratus Plane Block

Pectoral Nerve Block Type 2

Experimental group

Treatment:

Procedure: Pectoral Nerve Block Type II