跳至主要内容
临床试验/NCT03697538
NCT03697538终止不适用

The Effect of Femoral Nerve Block Versus Adductor Canal Block on the Quality of Recovery for Revision Total Knee Arthroplasty, a Prospective Randomized Blinded Study

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2018年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
51
试验地点
2
主要终点
Quality of recovery-15 item questionnaire (QoR): QoR-15

研究概览

简要总结

This is a prospective, randomized, blinded study with a parallel design and an allocation ratio of 1:1 for the treatment groups. The investigators seek to determine if femoral nerve block (FNB) improves the quality of recovery and improve postoperative analgesia compared with adductor canal block (ACBs) for patients undergoing revision total knee arthroplasty.

详细描述

This is a prospective, randomized, blinded study with a parallel design and an allocation ratio of 1:1 for the treatment groups. A prospective study design will allow both FNBs and ACBs to be accurately assessed in an effective manner without introducing unnecessary confounding factors. Furthermore, randomization and a parallel design with equal allocation ratio will ensure timely enrollment of patients while also minimizing temporal confounders that may occur with institutional changes to clinical care protocols. Patients, nurses on the floor and physical therapists will be blinded to the nature of the patient assignment (FNB or ACB)

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)

盲法说明

Patients, nurses on the floor and physical therapists will be blinded to the nature of the patient assignment

入排标准

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

入选标准

  • Adult male or female patients ages 18-80 scheduled for elective revision TKA.
  • American Society of Anesthesiologists (ASA) physical status I -III
  • Mentally competent and able to give consent for enrollment in the study.

排除标准

  • Patients with any contraindications to regional anesthesia such as infection, nerve injury, anticoagulation.
  • Patient refusal.
  • Patients with an allergy to local anesthetics or systemic opioids.

结局指标

主要结局

Quality of recovery-15 item questionnaire (QoR): QoR-15

时间窗: 48 hours after surgery

Our primary objective will be to determine if FNBs will result in improved quality of recovery (QoR-15) compared with ACBs (at 48 hours). The questionnaire is 15 questions with a scale from 0-10 on each and composed of two parts; part A and Part B scoring for questions in part A ( questions from 1-10) are scored from 0-10 where 0=none of the time( poor), and 10= all of the time (excellent). Part Bare questions from 11-15 where they are scored from (10-0) where 10=none of the time ( excellent) and 0=all of the time ( poor). The sum of all answers are added together

次要结局

  • Opioid consumption(48 hours post-op)
  • Pain score measurement: we will use Numeric rating scale for measurement (NRS)(48 hours post-op)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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