跳至主要内容
临床试验/NCT03615430
NCT03615430已完成不适用

The Effect of Serratus Plane Block in Preventing Postoperative Pain and Chronic Pain After Breast Cancer Surgery

Feng Xia1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Numerical Rating Scale (NRS) of chronic pain

研究概览

简要总结

A prospective, double-blinded randomized controlled, 1-year follow-up study was designed to compare the analgesic effect of serratus plane block (SPB) after breast cancer surgery. Women undergoing radical mastectomy were dIvided into Control group and SPB group. The postoperative acute pain was evaluated by numerical rating scale (NRS) and the effect of preventing chronic pain was assessed at 3, 6, 12 months after surgery by NRS.

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 85 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • women undergoing radical mastectomy with either sentinel lymph node dissection or axillary lymph node dissection or no axillary lymph node dissection
  • between the ages of 18 and 85 yr
  • with an American Society of Anesthesiology (ASA) physical status I or II
  • without any significant cardiopulmonary, renal and hepatic dysfunction

排除标准

  • Patients with any previous cancer other than breast cancer
  • occurrence of allergy to local anesthetics
  • occurrence of opioid-tolerant subjects
  • occurrence of consuming analgesics, sedatives, antidepressants or any history of substance abuse before surgery

结局指标

主要结局

Numerical Rating Scale (NRS) of chronic pain

时间窗: 3 months after surgery

Pain intensity of patients was evaluated by Numerical Rating Scale, rating from 0 (no pain) to 10 (extreme pain) in order to evaluate the effect of SPB in preventing chronic pain

次要结局

  • Morphine consumption(0-24 hours after operation)
  • the change trend of Numerical Rating Scale (NRS) after surgery(0-24 hours after operation)

研究者

发起方
Feng Xia
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Feng Xia

Professor

First Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

Loading locations...

相似试验