Genicular Nerve Block for Total Knee Arthroplasty

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03706313
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 9.2
• Patients Per Site Per Month: 4.3

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• 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: Jan 15, 2019
• Actual Primary Completion Date: Oct 16, 2019
• Actual Study Completion Date: Oct 22, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Opioid Consumption at 24 Hours Post-op [24 hours after operation]

   Opioid consumption documented in medical recorded will be converted to oral morphine equivalents.

Secondary Outcome Measures

1. Worst Pain Rating Score (NRS-11) at Rest on Postoperative Day 1 [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.

2. Worst Pain Rating Score (NRS-11) With Movement on Postoperative Day 1 [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.

3. Total Opioid Consumption Through 48 Hours [48 hours]

   Total of all opioids consumed converted to oral morphine equivalents.

4. Opioid Consumption on Postoperative Day 7 [Postoperative day 7]

   Self-reported (by telephone questionnaire) opioid consumption in oral morphine equivalents on postoperative day 7

5. Worst Pain Rating Score (NRS-11) on Postoperative Day 7 [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.

6. Sleep Quality Measured by Number of Times Awakened by Pain During the First Postoperative Night [Postoperative 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. Patient Satisfaction With Pain Control at 24 h [24 hours]

   Patient reported satisfaction with his/her pain control at 24 h on a scale of 0-10 (0=completely dissatisfied, 10=completely satisfied)

8. Patient Satisfaction With Pain Control on Postoperative Day 7 [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)

9. 20 Meter Walk Test Time Performed on Postoperative Day 1 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Hospital	Durham	North Carolina	United States	27705

Sponsors and Collaborators

• Duke University

Investigators

• Principal Investigator: Jeffrey Gadsden, MD, Duke University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 3, 2018

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT03706313
• Other Study ID Numbers: Pro00100879
• First Posted: Oct 15, 2018
• Last Update Posted: Apr 1, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Pain, Postoperative; Bupivacaine

Study Results

Participant Flow

Arm/Group Title	Genicular Nerve Block With Bupivacaine and Dexamethasone	Genicular Nerve Block With Saline
Arm/Group 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. 5 mL of 0.25% bupivacaine 0.67 mg dexamethasone will be administered at each of the 3 genicular nerves.	The ultrasound-guided sham genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. 5 mL of 0.9% normal saline will be administered at each of the 3 genicular nerves.
Period Title: Overall Study
STARTED	20	20
COMPLETED	20	20
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Genicular Nerve Block With Bupivacaine and Dexamethasone	Genicular Nerve Block With Saline	Total
Arm/Group 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. 5 mL of 0.25% bupivacaine 0.67 mg dexamethasone will be administered at each of the 3 genicular nerves.	The ultrasound-guided sham genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. 5 mL of 0.9% normal saline will be administered at each of the 3 genicular nerves.	Total of all reporting groups
Overall Participants	20	20	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70.9 (6.8)	67.1 (7.6)	68.9 (7.4)
Sex: Female, Male (Count of Participants)
Female	10 50%	7 35%	17 42.5%
Male	10 50%	13 65%	23 57.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	20 100%	20 100%	40 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	1 5%	1 2.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 5%	0 0%	1 2.5%
White	19 95%	19 95%	38 95%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	20 100%	20 100%	40 100%
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	171.1 (10.0)	170.4 (11.3)	170.7 (10.5)
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	86.5 (19.8)	87.2 (17.5)	86.8 (18.5)
Body Mass Index (kg/m∧2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m∧2]	29.3 (4.7)	30.0 (5.3)	29.7 (4.9)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Genicular Nerve Block With Bupivacaine and Dexamethasone	Genicular Nerve Block With Saline
Arm/Group 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. 5 mL of 0.25% bupivacaine 0.67 mg dexamethasone will be administered at each of the 3 genicular nerves.	The ultrasound-guided sham genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. 5 mL of 0.9% normal saline will be administered at each of the 3 genicular nerves.
Measure Participants	20	20
Mean (Standard Deviation) [milligrams of oral morphine equivalents]	22.9 (19.8)	58.1 (34.8)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Genicular Nerve Block With Bupivacaine and Dexamethasone	Genicular Nerve Block With Saline
Arm/Group 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. 5 mL of 0.25% bupivacaine 0.67 mg dexamethasone will be administered at each of the 3 genicular nerves.	The ultrasound-guided sham genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. 5 mL of 0.9% normal saline will be administered at each of the 3 genicular nerves.
Measure Participants	20	20
Mean (Standard Deviation) [score on a scale]	2.7 (1.9)	3.5 (1.6)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Genicular Nerve Block With Bupivacaine and Dexamethasone	Genicular Nerve Block With Saline
Arm/Group 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. 5 mL of 0.25% bupivacaine 0.67 mg dexamethasone will be administered at each of the 3 genicular nerves.	The ultrasound-guided sham genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. 5 mL of 0.9% normal saline will be administered at each of the 3 genicular nerves.
Measure Participants	20	20
Mean (Standard Deviation) [score on a scale]	4.9 (2.4)	6.3 (1.9)

4. Secondary Outcome

Title	Total Opioid Consumption Through 48 Hours
Description	Total of all opioids consumed converted to oral morphine equivalents.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Genicular Nerve Block With Bupivacaine and Dexamethasone	Genicular Nerve Block With Saline
Arm/Group 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. 5 mL of 0.25% bupivacaine 0.67 mg dexamethasone will be administered at each of the 3 genicular nerves.	The ultrasound-guided sham genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. 5 mL of 0.9% normal saline will be administered at each of the 3 genicular nerves.
Measure Participants	20	20
Mean (Standard Deviation) [milligrams of oral morphine equivalents]	50.3 (39.8)	97.6 (56.2)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Genicular Nerve Block With Bupivacaine and Dexamethasone	Genicular Nerve Block With Saline
Arm/Group 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. 5 mL of 0.25% bupivacaine 0.67 mg dexamethasone will be administered at each of the 3 genicular nerves.	The ultrasound-guided sham genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. 5 mL of 0.9% normal saline will be administered at each of the 3 genicular nerves.
Measure Participants	20	20
Mean (Standard Deviation) [milligrams of oral morphine equivalents]	10.4 (13.7)	22.6 (24.2)

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Genicular Nerve Block With Bupivacaine and Dexamethasone	Genicular Nerve Block With Saline
Arm/Group 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. 5 mL of 0.25% bupivacaine 0.67 mg dexamethasone will be administered at each of the 3 genicular nerves.	The ultrasound-guided sham genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. 5 mL of 0.9% normal saline will be administered at each of the 3 genicular nerves.
Measure Participants	20	20
Mean (Standard Deviation) [score on a scale]	4.4 (2.0)	5.0 (2.2)

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Genicular Nerve Block With Bupivacaine and Dexamethasone	Genicular Nerve Block With Saline
Arm/Group 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. 5 mL of 0.25% bupivacaine 0.67 mg dexamethasone will be administered at each of the 3 genicular nerves.	The ultrasound-guided sham genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. 5 mL of 0.9% normal saline will be administered at each of the 3 genicular nerves.
Measure Participants	20	20
Median (Full Range) [number of times awoken by pain]	0	1

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Genicular Nerve Block With Bupivacaine and Dexamethasone	Genicular Nerve Block With Saline
Arm/Group 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. 5 mL of 0.25% bupivacaine 0.67 mg dexamethasone will be administered at each of the 3 genicular nerves.	The ultrasound-guided sham genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. 5 mL of 0.9% normal saline will be administered at each of the 3 genicular nerves.
Measure Participants	20	20
Mean (Standard Deviation) [score on a scale]	9.1 (0.9)	8.6 (1.1)

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Genicular Nerve Block With Bupivacaine and Dexamethasone	Genicular Nerve Block With Saline
Arm/Group 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. 5 mL of 0.25% bupivacaine 0.67 mg dexamethasone will be administered at each of the 3 genicular nerves.	The ultrasound-guided sham genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. 5 mL of 0.9% normal saline will be administered at each of the 3 genicular nerves.
Measure Participants	20	20
Mean (Standard Deviation) [score on a scale]	8.8 (1.6)	8.9 (1.2)

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Genicular Nerve Block With Bupivacaine and Dexamethasone	Genicular Nerve Block With Saline
Arm/Group 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. 5 mL of 0.25% bupivacaine 0.67 mg dexamethasone will be administered at each of the 3 genicular nerves.	The ultrasound-guided sham genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. 5 mL of 0.9% normal saline will be administered at each of the 3 genicular nerves.
Measure Participants	20	20
Mean (Standard Deviation) [seconds]	74.2 (40.8)	80.2 (43.6)

Adverse Events

Time Frame	7 days
Arm/Group Title	Genicular Nerve Block With Bupivacaine and Dexamethasone		Genicular Nerve Block With Saline
Arm/Group 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. 5 mL of 0.25% bupivacaine 0.67 mg dexamethasone will be administered at each of the 3 genicular nerves.		The ultrasound-guided sham genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. 5 mL of 0.9% normal saline will be administered at each of the 3 genicular nerves.
All Cause Mortality
	Genicular Nerve Block With Bupivacaine and Dexamethasone		Genicular Nerve Block With Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Serious Adverse Events
	Genicular Nerve Block With Bupivacaine and Dexamethasone		Genicular Nerve Block With Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Genicular Nerve Block With Bupivacaine and Dexamethasone		Genicular Nerve Block With Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.