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ACB v FNB for Revision TKA

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合作者:
信息的提供 (责任方):
October 3, 2018
October 5, 2018
October 5, 2018
October 2018
December 2019   (主要结果测量的最终数据收集日期)
Quality of recovery-15 item questionnaire (QoR): QoR-15[ Time Frame: 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

与当前相同
  • Opioid consumption[ Time Frame: 48 hours post-op ]
    Opioid requirements during hospitalization will be measured. Total opioid consumption during this time period after surgery will be standardized to morphine equivalent doses and calculated on a milligram basis for this time period or until discharge, whichever occurs first
  • Pain score measurement: we will use Numeric rating scale for measurement (NRS)[ Time Frame: 48 hours post-op ]
    Pain scores on a 0-10 numerical rating scale (NRS) where 0= no pain and 10= the worst pain ever. the scores will be assessed every 8 hours from nursing documentation through 48 hours or until discharge, whichever occurs first
 
ACB v FNB for Revision TKA
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

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.

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)
Interventional
N/A
分配: Randomized
干预模型: Parallel Assignment
干预模型描述:
盲法: Interventional
盲法描述:Patients, nurses on the floor and physical therapists will be blinded to the nature of the patient assignment
主要目的: Treatment
  • Procedure: Nerve Block for pain control post-revision total knee arthroplasty
    A 20g catheter will be introduced and advanced 2-3 cm beyond the tip of the needle under ultrasound visualization. After needle withdrawal, catheter placement will be checked by visualizing local anesthetic spread under ultrasound. 0.5% ropivacaine will be used for catheter placement. At the conclusion of surgery, the catheters will be connected to a pump that will infuse ropivacaine 0.2% at 6 mL/hr with a patient controlled bolus of 5mL and a lockout of 30 minutes.
  • Experimental: Adductor Canal Block
    A 20g catheter will be introduced and advanced 2-3 cm beyond the tip of the needle under ultrasound visualization. After needle withdrawal, catheter placement will be checked by visualizing local anesthetic spread under ultrasound. 0.5% ropivacaine will be used for catheter placement. At the conclusion of surgery, the catheters will be connected to a pump that will infuse ropivacaine 0.2% at 6 mL/hr with a patient controlled bolus of 5mL and a lockout of 30 minutes.
  • Active Comparator: Femoral Nerve Block
    A 20g catheter will be introduced and advanced 2-3 cm beyond the tip of the needle under ultrasound visualization. After needle withdrawal, catheter placement will be checked by visualizing local anesthetic spread under ultrasound. 0.5% ropivacaine will be used for catheter placement. At the conclusion of surgery, the catheters will be connected to a pump that will infuse ropivacaine 0.2% at 6 mL/hr with a patient controlled bolus of 5mL and a lockout of 30 minutes.
 
Not yet recruiting
150
与当前相同
July 2020
December 2019   (主要结果测量的最终数据收集日期)
Inclusion Criteria: - 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. Exclusion Criteria: - 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.
参与研究的性别: All
最小年龄:18 Years ,最大年龄:80 Years  
没有
United States
 
Yes
研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No
计划分享 IPD: No
University of Pennsylvania
Principal Investigator: Nabil M Elkassabany, MD, MSCE University of Pennsylvania
October 2018

ICMJE     国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素
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