跳至主要内容
临床试验/NCT06082206
NCT06082206招募中不适用

Pectoral Nerve Block Versus Paravertebral Block In The Incidence of Chronic Pain After Breast Cancer Surgery: A Randomized Clinical Trial

Assiut University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
90
试验地点
1
主要终点
The incidence of chronic pain

研究概览

简要总结

Chronic pain after Mastectomy is frequent and an important healthcare priority because of its effect on quality of life. Although the association between the severity of acute pain after surgery and the likelihood of chronic pain is known, their causal relationship has not been clarified. Mastectomy, frequently done for the management of breast cancer, is associated with significant acute postoperative pain and limited shoulder movement.

详细描述

General anesthesia with postoperative NSAI D and opioids is a commonly used technique for postoperative analgesia after breast surgeries. Patients with mastectomy under general anesthesia commonly have pain in the axilla and upper limb that increases hospital stay, costs, and postoperative complications .Thoracic paravertebral block can be performed for analgesia after breast surgery. Ultrasound usage gave an accurate reading of the depth to the paravertebral space and can be used during the whole technique. Breast surgery is usually done with axillary dissection and can be done at single or multiple levels of thoracic paravertebral blocks .Thoracic paravertebral block is associated with multiple complications such as hypotension, pneumothorax, sympathetic block, central spread of local anesthesia or failed block which may cause limitations in the technique. The use of ultrasound in anesthesia increases the success rate of the block and decreases the incidence of variable complications .On the other hand, many interfascial plane blocks have been described. Pectoral nerve block (PECS) has been described as interfascial plane blocks and provide analgesic adjuvants for breast surgery with or without axillary dissection. The block was described as an injection of local anesthetic between the pectoralis major and minor muscles (PEC I) and between pectoralis minor and serratus anterior muscle (PEC 2) .

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • ASA grade I, II, or III female patients in the age group of 20-65 years
  • with body mass index (BMI) of 25-35 who were undergoing mastectomy with or without axillary lymph node or sentinel lymph node dissection or partial mastectomy (sparing the skin, areola, and nipple) with axillary lymph node dissection

排除标准

  • male sex; patient refusal,
  • a life expectancy less than 2 yr;
  • active malignant disease; pregnant or breastfeeding women;
  • bilateral surgery; ipsilateral breast surgery in the past 3 yr;

研究组 & 干预措施

TPVB Group

Experimental

Bupivacaine 0.25% 20 ml was injected between the costotransverse ligament and the parietal pleura.

干预措施: thoracic paravertebral block (TPVB) (Procedure)

PECS Group

Experimental

10 mL of 0.25% bupivacaine between the pectoralis major and minor muscles. and 10 mL of 0.25% bupivacaine between the pectoralis minor and serratus anterior muscles at the level of the 4th rib.

干预措施: PECS group (Procedure)

结局指标

主要结局

The incidence of chronic pain

时间窗: 3 and 6 months

The incidence of chronic pain, with a Douleur Neuropathique 4 (DN4) questionnaire score ≥ 4, indicating neuropathic pain.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ghada Mohammed AboelFadl

Principal investigator

Assiut University

研究点 (1)

Loading locations...

相似试验