Comparing the QoR of PECS Block and GA in Breast-conserving Surgery With Sentinel Lymph Node Biopsy
- Conditions
- Breast CancerBreast-Conserving SurgerySentinel Lymph Node BiopsyPectoral Nerves Block
- Registration Number
- NCT06120439
- Lead Sponsor
- Jun Zhang
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 96
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Postoperative QoR-15 at 6 hours 6 hours after the surgery The 15-item quality of recovery(QoR-15) at 6 hours after the surgery.
- Secondary Outcome Measures
Name Time Method The number of patients who experience intraoperative hypotension From the beginning of anesthesia to the end of the surgery. During the surgery and anesthesia process, MAP ≤ 65 mmHg is defined as intraoperative hypotension. Record the number of patients who experience intraoperative hypotension.
Changes in hemodynamics (mean arterial pressure) after the surgical incision. From the beginning of anesthesia to three minutes after the surgical incision. Monitor the magnitude of hemodynamic changes compared to baseline after the incision. The main comparison is the magnitude of changes in mean arterial pressure between the two groups.
Changes in hemodynamics (heart rate) after the surgical incision. From the beginning of anesthesia to three minutes after the surgical incision. Monitor the magnitude of hemodynamic changes compared to baseline after the incision. The main comparison is the magnitude of changes in heart rate between the two groups.
Postoperative NRS pain score at 6 hours 6 hours after the surgery Postoperative numeric rating scales pain score at 6 hours after the surgery. Postoperative pain severity at rest and movement measured using a numerical rating scale(NRS) at 24 h. The numerical rating scale (NRS) is a line with numbers from 0 to 10 are spaced evenly across the page. And the NRS is bounded at the left-most end with "no pain" and at the right-most end with "worst pain imaginable". Pain levels below "4" are considered mild, "4-7" is moderate pain, and anything above "7" is considered severe pain. Patients are instructed to circle the number that represents the amount of pain that they are experiencing at the time of the evaluation. The movement status refers to maximum mobility of the upper arm of the surgical side. Remedial pain relief measures are initiated when the Numeric Rating Scale (NRS) score exceeds 4.
Trial Locations
- Locations (1)
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Fudan University Shanghai Cancer Center🇨🇳Shanghai, Shanghai, China