Comparison Between Pectoral Nerve Block II and Local Anesthesia Infiltration of Isobaric Bupivacaine 0.25% 50 MG on Neutrophil-Lymphocyte Ratio, Interleukin-6 Levels, Pain Intensity, and Post-surgical Opioid Requirements in Modified Radical Mastectomy Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Concentration of Plasma Interleukin-6
研究概览
简要总结
Studied the comparison between PECS II block and LIA on pain intensity, opioid requirements, RNL, and postoperative IL-6 levels in MRM patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18-60 years old.
- •Body weight (BW): 50-70 kg.
- •Height (TB): 150-170 cm.
- •Body mass index (BMI): 18.5-29.9 kg/m
- •American Society of Anesthesiologists physical status (ASA PS) class I-II.
- •Patients undergoing elective MRM surgery under general anesthesia.
排除标准
- •Patients with contraindications to PECS II block.
- •Patients with contraindications to LIA.
- •Patients with coagulation disorders or receiving anticoagulant therapy.
- •Patients with a history of chronic pain.
- •Patients with a history of allergy to study materials.
- •Patients with a history of previous breast surgery.
- •Patient refuses to participate in the study.
研究组 & 干预措施
PECS
PECS II block before surgery using isobaric bupivacaine 0.25% 20 mL (50 mg)
干预措施: PECS II block (Drug)
LIA
Local infiltration anesthesia after completion of surgery using isobaric bupivacaine 0.25% 20 mL (50 mg)
干预措施: LIA (Drug)
结局指标
主要结局
Concentration of Plasma Interleukin-6
时间窗: 1 hour before surgery, 2 hour after surgery, 12 hour after surgery
in pg/dL
Neutrophil-lymphocyte ratio
时间窗: 1 hour before surgery, 2 hour after surgery, 12 hour after surgery
Neutrophil divided by lymphocyte
Pain intensity (Using Numeric Rating Scale)
时间窗: hour 0, 2, 4, 6, 12, 24
Scale from 0-10, lower score = better outcome
Rescue opioid requirement
时间窗: Within 24 hours after surgery
Using fentanyl at a dose of 0.5-1 μg/kg/IV titrated as needed, in mcg (given if the patient had NRS of \>4/10)
次要结局
- Demographic baseline data(baseline (before the surgery))
- Time until first rescue opioid requirement(Within 24 hours after surgery)
- Nausea and vomiting(Within 24 hours after surgery)
研究者
Jokevin Prasetyadhi
Principal Investigator
Hasanuddin University