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Genicular Nerve Block for Total Knee Arthroplasty

Primary Purpose

Post-operative Pain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
15mL 0.25% bupivacaine
Genicular nerve block
Saline
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post-operative Pain focused on measuring Total knee replacement

Eligibility Criteria

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

Inclusion Criteria:

  • Subjects scheduled for primary elective total knee arthroplasty
  • American Society of Anesthesiologists Physical Status I-III
  • BMI 18-40 kg/m2

Exclusion Criteria:

  • Inability to cooperate with protocol
  • Inability to understand or speak English
  • Allergy to ropivacaine, bupivacaine or other local anesthetic
  • Contraindication to peripheral nerve block (e.g. local infection, neurologic deficit or disorder, previous trauma or surgery to ipsilateral knee, etc.)
  • Revision knee surgery
  • Chronic opioid consumption (daily morphine equivalent of >30 mg for at least four weeks prior to surgery)
  • History of chronic pain
  • History of psychiatric disorder
  • History of diabetes mellitus

Sites / Locations

  • Duke University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Genicular nerve block with bupivacaine

Genicular nerve block with saline

Arm Description

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. Color Doppler will be used to identify the arterial structures which serve as landmarks for the corresponding nerves. After skin local anesthetic infiltration, a 10 cm 21G insulated block needle will be inserted and aligned with the ultrasound scanning plane. Once satisfactory position of the needle is confirmed, 5mL of a solution containing 15 ml 0.25% bupivacaine with 2mg dexamethasone or 5mL saline will be slowly injected. Spread of local anesthetic will be documented adjacent to the target nerve. This procedure will be performed at the site of the three genicular nerves described.

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. Color Doppler will be used to identify the arterial structures which serve as landmarks for the corresponding nerves. After skin local anesthetic infiltration, a 10 cm 21G insulated block needle will be inserted and aligned with the ultrasound scanning plane (in-plane approach). Once satisfactory position of the needle time is confirmed, 5mL of a saline will be slowly injected. Spread of local anesthetic will be documented adjacent to the target nerve. This procedure will be performed at the site of the three genicular nerves described.

Outcomes

Primary Outcome Measures

Opioid Consumption at 24 Hours Post-op
Opioid consumption documented in medical recorded will be converted to oral morphine equivalents.

Secondary Outcome Measures

Worst Pain Rating Score (NRS-11) at Rest on Postoperative Day 1
The Numerical Rating Scale (NRS) is an 11-point numeric rating scale, with 0 representing "no pain" and 10 "unbearable pain." This scale demonstrates reliability and validity and is widely used to assess acute pain after surgery.
Worst Pain Rating Score (NRS-11) With Movement on Postoperative Day 1
The Numerical Rating Scale (NRS) is an 11-point numeric rating scale, with 0 representing "no pain" and 10 "unbearable pain." This scale demonstrates reliability and validity and is widely used to assess acute pain after surgery.
Total Opioid Consumption Through 48 Hours
Total of all opioids consumed converted to oral morphine equivalents.
Opioid Consumption on Postoperative Day 7
Self-reported (by telephone questionnaire) opioid consumption in oral morphine equivalents on postoperative day 7
Worst Pain Rating Score (NRS-11) on Postoperative Day 7
The Numerical Rating Scale (NRS) is an 11-point numeric rating scale, with 0 representing "no pain" and 10 "unbearable pain." This scale demonstrates reliability and validity and is widely used to assess acute pain after surgery.
Sleep Quality Measured by Number of Times Awakened by Pain During the First Postoperative Night
The patient will be questioned by a member of the research team about how many times they were awoken by pain overnight.
Patient Satisfaction With Pain Control at 24 h
Patient reported satisfaction with his/her pain control at 24 h on a scale of 0-10 (0=completely dissatisfied, 10=completely satisfied)
Patient Satisfaction With Pain Control on Postoperative Day 7
Patient reported satisfaction with his/her pain control on postoperative day 7 on a scale of 0-10 (0=completely dissatisfied, 10=completely satisfied)
20 Meter Walk Test Time Performed on Postoperative Day 1
This standardized test measures the time it takes for the participant to walk 20 meters at their usual walking pace. The 20-meter walk test is a physical function measure commonly used in clinical research studies and rehabilitation clinics to measure gait speed and monitor changes in patients' physical function over time.

Full Information

First Posted
October 11, 2018
Last Updated
March 5, 2021
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT03706313
Brief Title
Genicular Nerve Block for Total Knee Arthroplasty
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
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
October 16, 2019 (Actual)
Study Completion Date
October 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke 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
No

5. Study Description

Brief Summary
This study seeks to examine the analgesic efficacy of genicular nerve blocks for pain after total knee replacement.
Detailed Description
Part of the way in which pain is controlled during total knee replacement surgery is through a nerve block. The investigators have developed an effective protocol for pain control after knee replacement, but know that many patients still experience pain around the knee after knee replacement. There are nerves around the knee that carry pain impulses from behind the knee. The investigators believe that placing numbing medicine around these nerves can help with pain in front of the knee after surgery, in addition to the standard nerve block placed for knee replacement surgery. This may result in taking less pain medication by mouth,and having less pain with movement. For this study, before the operation, either a placebo solution or the local anesthetic bupivacaine (a numbing solution) will be placed at three sites around the knee where these nerves reside. The investigators will evaluate how participants feel in recovery after surgery, during the stay in the hospital, and call at home one week after surgery. Knowing if numbing these nerves helps with pain after surgery will help us further refine our postoperative care plan for patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain
Keywords
Total knee replacement

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Genicular nerve block with bupivacaine
Arm Type
Active Comparator
Arm Description
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. Color Doppler will be used to identify the arterial structures which serve as landmarks for the corresponding nerves. After skin local anesthetic infiltration, a 10 cm 21G insulated block needle will be inserted and aligned with the ultrasound scanning plane. Once satisfactory position of the needle is confirmed, 5mL of a solution containing 15 ml 0.25% bupivacaine with 2mg dexamethasone or 5mL saline will be slowly injected. Spread of local anesthetic will be documented adjacent to the target nerve. This procedure will be performed at the site of the three genicular nerves described.
Arm Title
Genicular nerve block with saline
Arm Type
Placebo Comparator
Arm Description
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. Color Doppler will be used to identify the arterial structures which serve as landmarks for the corresponding nerves. After skin local anesthetic infiltration, a 10 cm 21G insulated block needle will be inserted and aligned with the ultrasound scanning plane (in-plane approach). Once satisfactory position of the needle time is confirmed, 5mL of a saline will be slowly injected. Spread of local anesthetic will be documented adjacent to the target nerve. This procedure will be performed at the site of the three genicular nerves described.
Intervention Type
Drug
Intervention Name(s)
15mL 0.25% bupivacaine
Intervention Description
Patients will be randomly assigned to either a genicular nerve block with bupivacaine or saline
Intervention Type
Procedure
Intervention Name(s)
Genicular nerve block
Intervention Description
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. Color Doppler will be used to identify the arterial structures which serve as landmarks for the corresponding nerves. After skin local anesthetic infiltration, a 10 cm 21G insulated block needle will be inserted and aligned with the ultrasound scanning plane. Once satisfactory position of the needle is confirmed, 5mL of a solution containing 15 ml of 0.25% bupivacaine with 2mg dexamethasone or 5mL saline will be slowly injected. Spread of local anesthetic will be documented adjacent to the target nerve. This procedure will be performed at the site of the three genicular nerves described.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Patients will be randomly assigned to either a genicular nerve block with bupivacaine or saline
Primary Outcome Measure Information:
Title
Opioid Consumption at 24 Hours Post-op
Description
Opioid consumption documented in medical recorded will be converted to oral morphine equivalents.
Time Frame
24 hours after operation
Secondary Outcome Measure Information:
Title
Worst Pain Rating Score (NRS-11) at Rest on Postoperative Day 1
Description
The Numerical Rating Scale (NRS) is an 11-point numeric rating scale, with 0 representing "no pain" and 10 "unbearable pain." This scale demonstrates reliability and validity and is widely used to assess acute pain after surgery.
Time Frame
Postoperative Day 1
Title
Worst Pain Rating Score (NRS-11) With Movement on Postoperative Day 1
Description
The Numerical Rating Scale (NRS) is an 11-point numeric rating scale, with 0 representing "no pain" and 10 "unbearable pain." This scale demonstrates reliability and validity and is widely used to assess acute pain after surgery.
Time Frame
Postoperative day 1
Title
Total Opioid Consumption Through 48 Hours
Description
Total of all opioids consumed converted to oral morphine equivalents.
Time Frame
48 hours
Title
Opioid Consumption on Postoperative Day 7
Description
Self-reported (by telephone questionnaire) opioid consumption in oral morphine equivalents on postoperative day 7
Time Frame
Postoperative day 7
Title
Worst Pain Rating Score (NRS-11) on Postoperative Day 7
Description
The Numerical Rating Scale (NRS) is an 11-point numeric rating scale, with 0 representing "no pain" and 10 "unbearable pain." This scale demonstrates reliability and validity and is widely used to assess acute pain after surgery.
Time Frame
Postoperative day 7
Title
Sleep Quality Measured by Number of Times Awakened by Pain During the First Postoperative Night
Description
The patient will be questioned by a member of the research team about how many times they were awoken by pain overnight.
Time Frame
Postoperative day 1
Title
Patient Satisfaction With Pain Control at 24 h
Description
Patient reported satisfaction with his/her pain control at 24 h on a scale of 0-10 (0=completely dissatisfied, 10=completely satisfied)
Time Frame
24 hours
Title
Patient Satisfaction With Pain Control on Postoperative Day 7
Description
Patient reported satisfaction with his/her pain control on postoperative day 7 on a scale of 0-10 (0=completely dissatisfied, 10=completely satisfied)
Time Frame
Postoperative day 7
Title
20 Meter Walk Test Time Performed on Postoperative Day 1
Description
This standardized test measures the time it takes for the participant to walk 20 meters at their usual walking pace. The 20-meter walk test is a physical function measure commonly used in clinical research studies and rehabilitation clinics to measure gait speed and monitor changes in patients' physical function over time.
Time Frame
On postoperative day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects scheduled for primary elective total knee arthroplasty American Society of Anesthesiologists Physical Status I-III BMI 18-40 kg/m2 Exclusion Criteria: Inability to cooperate with protocol Inability to understand or speak English Allergy to ropivacaine, bupivacaine or other local anesthetic Contraindication to peripheral nerve block (e.g. local infection, neurologic deficit or disorder, previous trauma or surgery to ipsilateral knee, etc.) Revision knee surgery Chronic opioid consumption (daily morphine equivalent of >30 mg for at least four weeks prior to surgery) History of chronic pain History of psychiatric disorder History of diabetes mellitus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Gadsden, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34261807
Citation
Rambhia M, Chen A, Kumar AH, Bullock WM, Bolognesi M, Gadsden J. Ultrasound-guided genicular nerve blocks following total knee arthroplasty: a randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2021 Oct;46(10):862-866. doi: 10.1136/rapm-2021-102667. Epub 2021 Jul 14.
Results Reference
derived

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Genicular Nerve Block for Total Knee Arthroplasty

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