ACB v FNB for Revision TKA

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

October 3, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

December 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

ACB v FNB for Revision TKA

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

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)

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:Patients, nurses on the floor and physical therapists will be blinded to the nature of the patient assignment
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

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.

Study Arms

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.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

150

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

July 2020

Estimated Primary Completion Date

December 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

University of Pennsylvania

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Nabil M Elkassabany, MD, MSCE University of Pennsylvania

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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