US Guided GNB vs Saline Injection for TKA

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03316118
• Other study ID #: STU#:00204116
• Status: Terminated
• Phase: Phase 4
• Start date: October 5, 2017
• Est. completion date: June 21, 2021

Study information

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

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 21, 2021
• Est. primary completion date: June 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Nerve Block
• Pain, Postoperative
• Postoperative Pain
• Total Knee Arthroplasty

Intervention

Drug:
• bupivacaine
Group 1 will receive genicular nerve block using bupivacaine
• saline
Group 2 will receive genicular nerve block using normal saline

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Length of Hospitalization	Length of hospitalization in hours from time to admission to time of discharge.	Admission to discharge from hospital