Trial Outcomes & Findings for Genicular Nerve Block for Total Knee Arthroplasty (NCT NCT03706313)
NCT ID: NCT03706313
Last Updated: 2021-04-01
Results Overview
Opioid consumption documented in medical recorded will be converted to oral morphine equivalents.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
24 hours after operation
Results posted on
2021-04-01
Participant Flow
Participant milestones
| Measure |
Genicular Nerve Block With Bupivacaine and Dexamethasone
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.
|
Genicular Nerve Block With Saline
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 Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Genicular Nerve Block for Total Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
Genicular Nerve Block With Bupivacaine and Dexamethasone
n=20 Participants
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.
|
Genicular Nerve Block With Saline
n=20 Participants
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
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.9 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
67.1 years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
68.9 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Height
|
171.1 cm
STANDARD_DEVIATION 10.0 • n=5 Participants
|
170.4 cm
STANDARD_DEVIATION 11.3 • n=7 Participants
|
170.7 cm
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Weight
|
86.5 kg
STANDARD_DEVIATION 19.8 • n=5 Participants
|
87.2 kg
STANDARD_DEVIATION 17.5 • n=7 Participants
|
86.8 kg
STANDARD_DEVIATION 18.5 • n=5 Participants
|
|
Body Mass Index
|
29.3 kg/m∧2
STANDARD_DEVIATION 4.7 • n=5 Participants
|
30.0 kg/m∧2
STANDARD_DEVIATION 5.3 • n=7 Participants
|
29.7 kg/m∧2
STANDARD_DEVIATION 4.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours after operationOpioid consumption documented in medical recorded will be converted to oral morphine equivalents.
Outcome measures
| Measure |
Genicular Nerve Block With Bupivacaine and Dexamethasone
n=20 Participants
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.
|
Genicular Nerve Block With Saline
n=20 Participants
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.
|
|---|---|---|
|
Opioid Consumption at 24 Hours Post-op
|
22.9 milligrams of oral morphine equivalents
Standard Deviation 19.8
|
58.1 milligrams of oral morphine equivalents
Standard Deviation 34.8
|
SECONDARY outcome
Timeframe: Postoperative Day 1The 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.
Outcome measures
| Measure |
Genicular Nerve Block With Bupivacaine and Dexamethasone
n=20 Participants
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.
|
Genicular Nerve Block With Saline
n=20 Participants
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.
|
|---|---|---|
|
Worst Pain Rating Score (NRS-11) at Rest on Postoperative Day 1
|
2.7 score on a scale
Standard Deviation 1.9
|
3.5 score on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Postoperative day 1The 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.
Outcome measures
| Measure |
Genicular Nerve Block With Bupivacaine and Dexamethasone
n=20 Participants
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.
|
Genicular Nerve Block With Saline
n=20 Participants
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.
|
|---|---|---|
|
Worst Pain Rating Score (NRS-11) With Movement on Postoperative Day 1
|
4.9 score on a scale
Standard Deviation 2.4
|
6.3 score on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: 48 hoursTotal of all opioids consumed converted to oral morphine equivalents.
Outcome measures
| Measure |
Genicular Nerve Block With Bupivacaine and Dexamethasone
n=20 Participants
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.
|
Genicular Nerve Block With Saline
n=20 Participants
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 Opioid Consumption Through 48 Hours
|
50.3 milligrams of oral morphine equivalents
Standard Deviation 39.8
|
97.6 milligrams of oral morphine equivalents
Standard Deviation 56.2
|
SECONDARY outcome
Timeframe: Postoperative day 7Self-reported (by telephone questionnaire) opioid consumption in oral morphine equivalents on postoperative day 7
Outcome measures
| Measure |
Genicular Nerve Block With Bupivacaine and Dexamethasone
n=20 Participants
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.
|
Genicular Nerve Block With Saline
n=20 Participants
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.
|
|---|---|---|
|
Opioid Consumption on Postoperative Day 7
|
10.4 milligrams of oral morphine equivalents
Standard Deviation 13.7
|
22.6 milligrams of oral morphine equivalents
Standard Deviation 24.2
|
SECONDARY outcome
Timeframe: Postoperative day 7The 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.
Outcome measures
| Measure |
Genicular Nerve Block With Bupivacaine and Dexamethasone
n=20 Participants
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.
|
Genicular Nerve Block With Saline
n=20 Participants
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.
|
|---|---|---|
|
Worst Pain Rating Score (NRS-11) on Postoperative Day 7
|
4.4 score on a scale
Standard Deviation 2.0
|
5.0 score on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Postoperative day 1The patient will be questioned by a member of the research team about how many times they were awoken by pain overnight.
Outcome measures
| Measure |
Genicular Nerve Block With Bupivacaine and Dexamethasone
n=20 Participants
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.
|
Genicular Nerve Block With Saline
n=20 Participants
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.
|
|---|---|---|
|
Sleep Quality Measured by Number of Times Awakened by Pain During the First Postoperative Night
|
0 number of times awoken by pain
Interval 0.0 to 3.0
|
1 number of times awoken by pain
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: 24 hoursPatient reported satisfaction with his/her pain control at 24 h on a scale of 0-10 (0=completely dissatisfied, 10=completely satisfied)
Outcome measures
| Measure |
Genicular Nerve Block With Bupivacaine and Dexamethasone
n=20 Participants
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.
|
Genicular Nerve Block With Saline
n=20 Participants
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.
|
|---|---|---|
|
Patient Satisfaction With Pain Control at 24 h
|
9.1 score on a scale
Standard Deviation 0.9
|
8.6 score on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Postoperative day 7Patient reported satisfaction with his/her pain control on postoperative day 7 on a scale of 0-10 (0=completely dissatisfied, 10=completely satisfied)
Outcome measures
| Measure |
Genicular Nerve Block With Bupivacaine and Dexamethasone
n=20 Participants
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.
|
Genicular Nerve Block With Saline
n=20 Participants
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.
|
|---|---|---|
|
Patient Satisfaction With Pain Control on Postoperative Day 7
|
8.8 score on a scale
Standard Deviation 1.6
|
8.9 score on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: On postoperative day 1This 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.
Outcome measures
| Measure |
Genicular Nerve Block With Bupivacaine and Dexamethasone
n=20 Participants
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.
|
Genicular Nerve Block With Saline
n=20 Participants
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.
|
|---|---|---|
|
20 Meter Walk Test Time Performed on Postoperative Day 1
|
74.2 seconds
Standard Deviation 40.8
|
80.2 seconds
Standard Deviation 43.6
|
Adverse Events
Genicular Nerve Block With Bupivacaine and Dexamethasone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Genicular Nerve Block With Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place