US Guided GNB vs Saline Injection for TKA

A Comparison of Analgesic Efficacy of Ultrasound-Guided Genicular Nerve Block Versus Saline Injection for Total Knee Replacement: a Prospective, Randomized Controlled Trial

Do ultrasound-guided genicular nerve blocks with 0.5% bupivacaine provide improved knee analgesia for patients recovering from total knee replacement surgery compared to saline injection?

Hypotheses:

The investigators hypothesize that the combination of ultrasound-guided adductor canal block (ACB) and genicular nerve block will achieve lower opioid consumption and therefore lead to decreased systemic side effects and improved overall satisfaction compared to ultrasound-guided saline injection for patients undergoing minimally invasive elective total knee arthroplasty (TKA).

Study Overview

• Status: Terminated
• Conditions: Postoperative Pain; Total Knee Arthroplasty; Nerve Block
• Intervention / Treatment: Drug: bupivacaine; Drug: saline

Detailed Description

The study medication and protocol will consist of Group 1 (Active) - ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine and ultrasound-guided genicular nerve blocks with 6 ml of 0.5% bupivacaine, and Group 2 (Control) - ultrasound-guided adductor canal block with 10 ml of 0.25% bupivacaine and ultrasound-guided genicular nerve blocks with 6 ml of normal saline. The surgeon will be blinded to the subjects study arm assignment.

An ultrasound-guided ACB will be performed at the level of the mid-thigh of the leg halfway between the superior anterior iliac spine and the patella. The femoral artery, femoral vein, saphenous nerve will be visualized by ultrasonography and the expansion of the adductor canal will be recorded. Sensory assessment of the saphenous distribution will be performed at 30 minutes. The ultrasound-guided genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. The superior lateral genicular nerve is located at the confluence of the lateral femoral shaft and the lateral femoral condyle (in the anteroposterior plane) and at the midpoint of the femur (in the lateral plane). The superior medial genicular nerve site is located at the confluence of the medial femoral shaft and the medial femoral condyle (in the anteroposterior plane) and at the midpoint of the femur (in the lateral plane). The inferior medial genicular nerve site is located at the confluence of the medial tibial shaft and the tibial flare (in the anteroposterior plane) and the midpoint of the tibia (in the lateral plane). Color Doppler will be used to identify the arterial structures which serve as landmarks for the corresponding nerves. All nerve blocks will be performed by a study team physician.

Postoperative follow-up will be done by study team member blinded to the group allocation. The dosing of oxycodone/hydrocodone-acetaminophen will be as needed with management goal of a Visual Analog Scale (VAS) score of ≤ 4. Patients with pain not managed by oral agents will receive IV medication. Patients will be visited during their hospital stay every six hours until discharge to record pain scores, opioid consumption, and patient satisfaction. In addition, patients will be given a pain diary to record (VAS) pain scores every six hours until hospital discharge.

A study team member will follow up patients by telephone (if discharged prior to) at 48 hours, 72 hours.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants 40 to 85 years old who are presenting for minimally invasive total knee arthroplasty under spinal anesthesia and are candidates for peripheral nerve blocks.
• Minimally invasive is defined as custom modified instrumentation, a quadriceps sparing arthrotomy that does not extend beyond 1cm proximal to the patella and surgical techniques that focus on soft tissue protection.

Exclusion Criteria:

• Patient refusal
• American Society of Anesthesiologists physical status classification of 4 or higher
• Pre-existing neuropathy in the femoral or sciatic distribution
• Coagulopathy
• Infection at the site
• Chronic opioid use (greater than 3 months)
• Pregnancy
• Medical conditions limiting physical therapy participation
• Any other contra-indication to regional anesthesia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; Patient will receive genicular nerve block with bupivacaine	Drug: bupivacaine; Group 1 will receive genicular nerve block using bupivacaine; Other Names: BUPIV
Placebo Comparator: Group 2; Patient will receive normal saline as the nerve block	Drug: saline; Group 2 will receive genicular nerve block using normal saline; Other Names: SAL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative Opioid Consumption During the Hospital Stay	Post-operative opioid consumption measured in morphine milligram equivalents (MME)during the hospital stay up to 36 hours after surgery.	36 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Pain Scores of the Knee at Rest for the First 48 Hours After Surgery	Mean pain scores post operative reported using the VAS (visual analog scale) for knee pain at rest on a scale of 0 (no pain to 10 worst pain imaginable). This will be assessed every 6 hours up to 48 hours with the visual analog scale where 0 equals no pain and 10 represents excruciating pain.	48 hours after surgery
Overall Satisfaction With Pain Control 72 Hours After Surgery	Overall satisfaction with pain control 72 hours after surgery using a visual analog scale where 0 = not satisfied and 10 being extremely satisfied	72 hours after surgery
Length of Hospitalization	Length of hospitalization in hours from time to admission to time of discharge.	Admission to discharge from hospital

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Antoun M Nader, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2017
• Primary Completion (Actual): June 21, 2021
• Study Completion (Actual): June 21, 2021

Study Registration Dates

• First Submitted: October 5, 2017
• First Submitted That Met QC Criteria: October 18, 2017
• First Posted (Actual): October 20, 2017

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: pain; arthroplasty; anesthesiology
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: STU#:00204116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No