Pectoral Nerves Blocks and Their Effect on Chronic Pain After Breast Cancer Surgery
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- The incidence of chronic postoperative pain for 3 months after modified radical mastectomy surgery
研究概览
简要总结
The purpose of this study is to determine whether pectoral nerves blocks（PECS） would reduce chronic pain at 3 months after modified radical mastectomy（MRM）surgery.
详细描述
One hundred and forty adult female participants scheduled for elective unilateral modified radical mastectomy under general anesthesia are randomly allocated to receive either general anesthesia plus Pecs block(Pecs group, n=70) or general anesthesia alone (control group, n=70).
After arrived in the operating room，the participants in the control group are accepted the general anesthesia.Whereas，after anesthesia induction，the participants in the Pecs group receive an ultrasound-guided Pecs block and a 15 minute observation time prior before the start of the operation.
Pecs block technology： A broadband (5-12 hertz) linear array probe of Sonosite Edge portable ultrasound system (Sonosite Inc,Bethel,Washington) is used, with an imaging depth of 4 to 6 cm. After cleaning the infraclavicular and axillary regions with chlorhexidine, the probe is placed below the lateral third of the clavicle, similar to what is done when performing infraclavicular brachial plexus block. After recognition of the appropriate anatomical structures, the skin puncture point is infiltrated with 2% lignocaine, then the block is performed by using a 20-gauge Tuohy needle. The needle is advanced to the tissue plane between the pectoralis major and pectoralis minor muscle at the vicinity of the pectoral branch of the acromiothoracic artery, and 10 mL of 0.35% ropivacaine deposited. In a similar manner, 20 mL is deposited at the level of the third rib below the serratus anterior muscle with the intent of spreading injectate to the axilla.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Modified radical mastectomy
- •American Society of Anesthesiologists physical status 1-3
- •BMI 18-35 kg/m2
排除标准
- •Declining to give written informed consent；
- •Uncontrolled hypertension；
- •Allergy to local anesthetics；
- •Pregnancy；
- •Alcohol or drug abuse；
- •Prior breast surgery except for diagnostic biopsies；
- •Contraindication to the use of regional anesthesia；
- •History of chronic pain or psychiatric disorder and pregnant patients；
- •Consumption of NSAID, cyclooxygenase-2 inhibitors or paracetamol within 24 hours before the investigation；
- •Infection at the needle site.
- •Inability to properly describe postoperative pain to investigators (eg, language barrier, neuropsychiatric disorder)
研究组 & 干预措施
Ropivacaine
Ropivacaine hydrochloride injection； Generic name：Naropin； Dosage form：Liquid、Injectable formulation； Dosage：105mg；30ml； Frequency：Once.
干预措施: Ropivacaine (Drug)
Normal saline
Medical Normal saline Generic name：Normal saline； Dosage form：Liquid、Injectable formulation； Dosage：30ml； Frequency：Once.
干预措施: Normal saline (Drug)
结局指标
主要结局
The incidence of chronic postoperative pain for 3 months after modified radical mastectomy surgery
时间窗: 3 months after modified radical mastectomy surgery
An anesthesiologist interviews the patients by phone to determine the postoperative pain at 3 months after surgery. Chronic pain is defined as pain in the surgical area or the ipsilateral arm, present at least 4 days a week, with an intensity of 3 or more on the verbal rating scale（0=no pain to 10=worst imaginable pain),described as a typical neuropathic pain consisting of burning pain, shooting pain, pain evoked by pressure, and deep blunt pain.
次要结局
- Postoperative Numerical Rating scale (NRS) score for pain(72 hours postoperative)