Adductor Canal Block (ACB) vs Femoral Nerve Block (FNB) in Revision Total Knee Arthroplasty

Revision Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03697538
• Other study ID #: 829859
• Status: Terminated
• Phase: N/A
• Start date: October 10, 2018
• Est. completion date: June 27, 2022

Study information

• Verified date: September 2022
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: June 27, 2022
• Est. primary completion date: June 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Revision Total Knee Arthroplasty

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of recovery-15 item questionnaire (QoR): QoR-15	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	48 hours after surgery
Secondary	Opioid consumption	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	48 hours post-op
Secondary	Pain score measurement: we will use Numeric rating scale for measurement (NRS)	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	48 hours post-op