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Genicular Nerve Block for Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT03706313
Recruitment Status : Completed
First Posted : October 15, 2018
Results First Posted : November 5, 2020
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Supportive Care
Condition Post-operative Pain
Interventions Drug: 15mL 0.25% bupivacaine
Procedure: Genicular nerve block
Drug: Saline
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Genicular Nerve Block With Bupivacaine and Dexamethasone Genicular Nerve Block With Saline
Hide 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
Arm/Group Title Genicular Nerve Block With Bupivacaine and Dexamethasone Genicular Nerve Block With Saline Total
Hide 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 Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
70.9  (6.8) 67.1  (7.6) 68.9  (7.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
10
  50.0%
7
  35.0%
17
  42.5%
Male
10
  50.0%
13
  65.0%
23
  57.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
20
 100.0%
20
 100.0%
40
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   5.0%
1
   2.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   5.0%
0
   0.0%
1
   2.5%
White
19
  95.0%
19
  95.0%
38
  95.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 40 participants
20 20 40
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 20 participants 20 participants 40 participants
171.1  (10.0) 170.4  (11.3) 170.7  (10.5)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 20 participants 20 participants 40 participants
86.5  (19.8) 87.2  (17.5) 86.8  (18.5)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m∧2
Number Analyzed 20 participants 20 participants 40 participants
29.3  (4.7) 30.0  (5.3) 29.7  (4.9)
1.Primary Outcome
Title Opioid Consumption at 24 Hours Post-op
Hide Description Opioid consumption documented in medical recorded will be converted to oral morphine equivalents.
Time Frame 24 hours after operation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Genicular Nerve Block With Bupivacaine and Dexamethasone Genicular Nerve Block With Saline
Hide 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.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Genicular Nerve Block With Bupivacaine and Dexamethasone Genicular Nerve Block With Saline
Hide 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.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Genicular Nerve Block With Bupivacaine and Dexamethasone Genicular Nerve Block With Saline
Hide 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.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
4.9  (2.4) 6.3  (1.9)
4.Secondary Outcome
Title Total Opioid Consumption Through 48 Hours
Hide Description Total of all opioids consumed converted to oral morphine equivalents.
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Genicular Nerve Block With Bupivacaine and Dexamethasone Genicular Nerve Block With Saline
Hide 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.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: milligrams of oral morphine equivalents
50.3  (39.8) 97.6  (56.2)
5.Secondary Outcome
Title Opioid Consumption on Postoperative Day 7
Hide Description Self-reported (by telephone questionnaire) opioid consumption in oral morphine equivalents on postoperative day 7
Time Frame Postoperative day 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Genicular Nerve Block With Bupivacaine and Dexamethasone Genicular Nerve Block With Saline
Hide 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.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Genicular Nerve Block With Bupivacaine and Dexamethasone Genicular Nerve Block With Saline
Hide 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.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Genicular Nerve Block With Bupivacaine and Dexamethasone Genicular Nerve Block With Saline
Hide 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.
Overall Number of Participants Analyzed 20 20
Median (Full Range)
Unit of Measure: number of times awoken by pain
0
(0 to 3)
1
(0 to 4)
8.Secondary Outcome
Title Patient Satisfaction With Pain Control at 24 h
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Genicular Nerve Block With Bupivacaine and Dexamethasone Genicular Nerve Block With Saline
Hide 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.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Genicular Nerve Block With Bupivacaine and Dexamethasone Genicular Nerve Block With Saline
Hide 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.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Genicular Nerve Block With Bupivacaine and Dexamethasone Genicular Nerve Block With Saline
Hide 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.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: seconds
74.2  (40.8) 80.2  (43.6)
Time Frame 7 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Genicular Nerve Block With Bupivacaine and Dexamethasone Genicular Nerve Block With Saline
Hide 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 (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Hide Serious Adverse Events
Genicular Nerve Block With Bupivacaine and Dexamethasone Genicular Nerve Block With Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Genicular Nerve Block With Bupivacaine and Dexamethasone Genicular Nerve Block With Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jeff Gadsden
Organization: Duke University
Phone: 919-681-6437
EMail: jeff.gadsden@duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03706313    
Other Study ID Numbers: Pro00100879
First Submitted: October 11, 2018
First Posted: October 15, 2018
Results First Submitted: October 14, 2020
Results First Posted: November 5, 2020
Last Update Posted: April 1, 2021