NCT06120439

Comparing the QoR of PECS Block and GA in Breast-conserving Surgery With Sentinel Lymph Node Biopsy

Comparing the Quality of Recovery(QoR) of Pectoral Nerves(PECS) Block and General Anesthesia(GA) in Breast-conserving Surgery(BCS) With Sentinel Lymph Node Biopsy(SLNB):A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Jun Zhang · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The aim of this randomized controlled trial (RCT) is to assess the Quality of Recovery (QoR) in Breast-conserving Surgery (BCS) with Sentinel Lymph Node Biopsy (SLNB) using Pectoral Nerves (PECS) Block and General Anesthesia (GA). The primary objectives are as follows: First, to determine if the PECS group exhibits better QoR; Second, to investigate if the PECS group experiences less postoperative pain and complications; Third, to examine if the PECS group demonstrates more stable hemodynamics.

Detailed description

This study is a randomized controlled trial, with a 1:1 ratio for grouping. The experimental group is the T group, receiving Pecs II combined with intercostal nerve block, while the control group is the C group, receiving general anesthesia. The primary outcome measure is the QoR-15 score of the subjects 6 hours after surgery. Based on preliminary results, the control group had a QoR-15 score of 133±8 (n=6), and the experimental group needs to improve by at least 8 points (which is generally considered clinically significant, PMID:27159009). With a two-sided α=0.05 and a power of 99%, accounting for a 20% dropout rate, the final required sample size was calculated to be 96 cases, with 48 cases in each group. If the proportion of dropout cases is less than 5% and considered "completely random missing," the missing records generated by the dropout cases will be directly excluded. Depending on the specific circumstances, either single imputation or multiple imputation methods will be used.

Conditions

• Breast Cancer
• Pectoral Nerves Block
• Breast-Conserving Surgery
• Sentinel Lymph Node Biopsy

Interventions

Type	Name	Description
COMBINATION_PRODUCT	PECS II combined with intercostal nerve blockade;	The patient was in a supine position, and under ultrasound guidance, the needle tip was first placed in the plane between the pectoralis major and minor muscles, and 10ml of 0.3% ropivacaine was injected. The needle was then advanced into the space between the pectoralis minor and serratus anterior muscles, and 20ml of 0.3% ropivacaine was injected. Intercostal nerve blockade: The range of intercostal blockade was determined based on the location of the breast surgery. The needle was inserted into the intercostal space from the posterior axillary line, and 3ml of 0.3% ropivacaine was injected into each intercostal space.
COMBINATION_PRODUCT	General anesthesia with laryngeal mask	The C Group underwent general anesthesia induction using TCI propofol 3-3.5μg/ml, TCI remifentanil 1-2ng/ml, sufentanil 0.3μg/kg iv, midazolam 0.05mg/kg iv, and rocuronium 0.6mg/kg iv after loss of consciousness. After muscle relaxation, the laryngeal mask was inserted, and mechanical ventilation was performed with a tidal volume of 6ml/kg. Anesthesia maintenance included propofol 3-4μg/ml and remifentanil 1-2ng/ml.

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-05-11
• Completion: 2024-05-15
• First posted: 2023-11-07
• Last updated: 2025-11-18

Locations

1 site across 1 country: China