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Clinical Trials/NCT03697538
NCT03697538
Terminated
Not Applicable

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 Pennsylvania1 site in 1 country51 target enrollmentOctober 10, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Revision Total Knee Arthroplasty
Sponsor
University of Pennsylvania
Enrollment
51
Locations
1
Primary Endpoint
Quality of recovery-15 item questionnaire (QoR): QoR-15
Status
Terminated
Last Updated
3 years ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
October 10, 2018
End Date
June 27, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Study Sites (1)

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