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US Guided GNB vs Saline Injection for TKA

Primary Purpose

Postoperative Pain, Total Knee Arthroplasty, Nerve Block

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
bupivacaine
saline
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring anesthesiology, pain, arthroplasty

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group 1

Group 2

Arm Description

Patient will receive genicular nerve block with bupivacaine

Patient will receive normal saline as the nerve block

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
Length of Hospitalization
Length of hospitalization in hours from time to admission to time of discharge.

Full Information

First Posted
October 5, 2017
Last Updated
September 14, 2022
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT03316118
Brief Title
US Guided GNB vs Saline Injection for TKA
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Low Enrollment
Study Start Date
October 5, 2017 (Actual)
Primary Completion Date
June 21, 2021 (Actual)
Study Completion Date
June 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Total Knee Arthroplasty, Nerve Block
Keywords
anesthesiology, pain, arthroplasty

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Patient will receive genicular nerve block with bupivacaine
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Description
Patient will receive normal saline as the nerve block
Intervention Type
Drug
Intervention Name(s)
bupivacaine
Other Intervention Name(s)
BUPIV
Intervention Description
Group 1 will receive genicular nerve block using bupivacaine
Intervention Type
Drug
Intervention Name(s)
saline
Other Intervention Name(s)
SAL
Intervention Description
Group 2 will receive genicular nerve block using normal saline
Primary Outcome Measure Information:
Title
Post-operative Opioid Consumption During the Hospital Stay
Description
Post-operative opioid consumption measured in morphine milligram equivalents (MME)during the hospital stay up to 36 hours after surgery.
Time Frame
36 hours after surgery
Secondary Outcome Measure Information:
Title
Mean Pain Scores of the Knee at Rest for the First 48 Hours After Surgery
Description
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.
Time Frame
48 hours after surgery
Title
Overall Satisfaction With Pain Control 72 Hours After Surgery
Description
Overall satisfaction with pain control 72 hours after surgery using a visual analog scale where 0 = not satisfied and 10 being extremely satisfied
Time Frame
72 hours after surgery
Title
Length of Hospitalization
Description
Length of hospitalization in hours from time to admission to time of discharge.
Time Frame
Admission to discharge from hospital

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoun M Nader, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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US Guided GNB vs Saline Injection for TKA

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