Revision Total Knee Arthroplasty
Conditions
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)
Interventions
PROCEDURENerve 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.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients, nurses on the floor and physical therapists will be blinded to the nature of the patient assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of recovery-15 item questionnaire (QoR): QoR-15 | 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
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption | 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) | 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 |
Countries
United States
Outcome results
None listed