跳至主要内容
临床试验/NCT05528822
NCT05528822招募中不适用

Comparative Prospective Randomized Study of Modified Fascia Iliaca Compartment Block Versus Pericapsular Nerve Group Block in Elderly Patients' Total Hip Arthroplasty on the Post-operative Quality of Recovery

Affiliated Hospital of Nantong University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年12月1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
100
试验地点
1
主要终点
Change from Baseline visual analogue scale

研究概览

简要总结

Total joint replacement is projected to become the most common elective surgical procedure in the coming decade; the prevalence of total hip arthroplasty (THA) was estimated as more than 2.5 million individuals in the entire United States population. Orthopedic procedures involving the hip have remained challenging for regional anesthesia given the complex innervation, painful nature contributing to difficulty positioning, and a desire to maintain mobility to hasten postoperative recovery.

详细描述

By comparing the intraoperative and postoperative rehabilitation indexes of high fascia iliac nerve block and hip pericapsular nerve block, we can choose a more suitable analgesic method for this operation.

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
None

入排标准

年龄范围
65 Years 至 80 Years(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Aged 65 to 80 years male and female
  • •Scheduled for elective single-incision laparoscopic cholecystectomy
  • •The patients volunteered to participate in the study and signed the informed consent

排除标准

  • •Preexisting neuropathy
  • •Coagulopathy
  • •Local skin infection
  • •Hepatic, renal or cardiorespiratory failure
  • •Local anesthetic allergy
  • •Pregnancy
  • •Complications of gallstone with gallbladder perforation
  • •Diffuse peritonitis
  • •Acute pyogenic cholangitis

研究组 & 干预措施

Group F: H-FICB under ultrasound guidance before general anesthesia

Experimental

Group F was subjected to a high fascia iliaca compartment block under ultrasound guidance before general anesthesia.

干预措施: ultrasound-guided high fascia iliaca compartment block (Procedure)

Group P: PENG block under ultrasound guidance before general anesthesia

Experimental

Group P was subjected to a pericapsular nerve group (PENG) Block under ultrasound guidance before general anesthesia.

干预措施: ultrasound-guided pericapsular nerve group (PENG) block (Procedure)

结局指标

主要结局

Change from Baseline visual analogue scale

时间窗: one day before the operation.

Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0 to 100. A higher score indicates greater pain intensity. Based on the distribution of pain Visual Analogue Scale scores in post-surgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain Visual Analogue Scale have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).

Harris Hip Score

时间窗: At one week, one month, and three months post-operatively.

The HHS is divided into three sections. The first section are questions about pain and its impact which are answered by the patient or client. The second and third sections require the physiotherapist to assess the patient or client's hip joint and function.The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. Results can be recorded and calculated online. The maximum score possible is 100. Results can be interpreted with the following\[1\]: \<70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.

次要结局

  • The mini-mental State Examination(one day before the operation.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验