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

Jun Zhang

Status: Completed

Conditions: Breast Cancer; Sentinel Lymph Node Biopsy; Pectoral Nerves Block; Breast-Conserving Surgery

Treatments: Combination Product: General anesthesia with laryngeal mask; Combination Product: PECS II combined with intercostal nerve blockade;

Study type: Interventional

Funder types: Other

Identifiers

NCT06120439

CSYDXSJLHLJSJ-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled for breast-conserving surgery with sentinel lymph node biopsy.
• Age between 18 and 70 years.
• Body Mass Index (BMI) < 30 kg/m2.
• American Society of Anesthesiologists (ASA) classification grade I-III.

Exclusion criteria

• Contraindications to regional anesthesia: site infection at the puncture site, allergy to local anesthetics, coagulation disorders, or bleeding risks.
• Impaired liver or kidney function.
• Pregnancy, lactation, possibility of pregnancy, or planned pregnancy.
• Preoperative use of analgesic drugs, history of chronic pain, or history of opioid abuse.
• Mental illness.
• Patients who refuse to participate.
• Patients deemed unsuitable for the clinical trial by the researchers.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 2 patient groups

T Group

Experimental group

Description:

The T Group received PECS II(PMID: 22939099) combined with intercostal nerve block

Treatment:

Combination Product: PECS II combined with intercostal nerve blockade;

C Group

Active Comparator group

Description:

C Group underwent laryngeal mask insertion after general anesthesia induction.

Treatment:

Combination Product: General anesthesia with laryngeal mask