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Genicular Nerve Block for Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03706313
Recruitment Status : Completed
First Posted : October 15, 2018
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
This study seeks to examine the analgesic efficacy of genicular nerve blocks for pain after total knee replacement.

Condition or disease Intervention/treatment Phase
Post-operative Pain Drug: 15mL 0.25% bupivacaine Procedure: Genicular nerve block Drug: Saline Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
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
Actual Study Start Date : January 15, 2019
Actual Primary Completion Date : October 16, 2019
Actual Study Completion Date : October 22, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Active Comparator: Genicular nerve block with bupivacaine

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.

Drug: 15mL 0.25% bupivacaine
Patients will be randomly assigned to either a genicular nerve block with bupivacaine or saline

Procedure: Genicular nerve block

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.


Placebo Comparator: Genicular nerve block with saline

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.

Procedure: Genicular nerve block

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.


Drug: Saline
Patients will be randomly assigned to either a genicular nerve block with bupivacaine or saline




Primary Outcome Measures :
  1. Opioid consumption at 24 hours post-op [ Time Frame: 24 hours after operation ]
    Opioid consumption documented in medical recorded will be converted to oral morphine equivalents.


Secondary Outcome Measures :
  1. Pain rating scores (NRS-11) at rest [ Time Frame: Up to 48 hours ]
    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.

  2. Pain rating scores with movement [ Time Frame: Up to 48 hours ]
    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.

  3. Total opioid consumption [ Time Frame: 48 hours ]
    Opioid consumption documented in medical recorded will be converted to oral morphine equivalents.

  4. Opioid consumption measured by patient report [ Time Frame: Post-op day 7 ]
    The patient will be asked via phone questionnaire as to how many pain medication pills they have consumed since discharge.

  5. Pain score measured by patient report [ Time Frame: Post- op day 7 ]
    The patient will be asked via phone questionnaire as to how many pain medication pills they have consumed since discharge.

  6. Sleep quality measured by number of times awakened [ Time Frame: Post-op day 1 ]
    The patient will be questioned by a member of the research team about how many times they were awoken by pain overnight.

  7. Number of patients who report satisfaction with block technique [ Time Frame: 24 hours ]
    The patient will be asked if they are very satisfied, satisfied, dissatisfied or very dissatisfied with the block technique by a member of the research team.

  8. Number of patients who report satisfaction with block technique [ Time Frame: Post op day 7 ]
    The number of patients who report that they are very satisfied or satisfied will be counted by the research team.

  9. 20 meter walk test time [ Time Frame: Up to 30 minutes ]
    This 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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706313


Locations
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United States, North Carolina
Duke University Hospital
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Jeffrey Gadsden, MD Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03706313    
Other Study ID Numbers: Pro00100879
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Duke University:
Total knee replacement
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents