Trial Outcomes & Findings for US Guided GNB vs Saline Injection for TKA (NCT NCT03316118)
NCT ID: NCT03316118
Last Updated: 2022-09-28
Results Overview
Post-operative opioid consumption measured in morphine milligram equivalents (MME)during the hospital stay up to 36 hours after surgery.
TERMINATED
PHASE4
2 participants
36 hours after surgery
2022-09-28
Participant Flow
Participant milestones
| Measure |
Bupivacaine Block
Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine and ultrasound-guided genicular nerve blocks with 6 ml of 0.5% bupivacaine
|
Saline Sham
Ultrasound-guided adductor canal block with 10 ml of 0.25% bupivacaine and ultrasound-guided genicular nerve blocks with 6 ml of normal saline.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
0
|
|
Overall Study
COMPLETED
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
US Guided GNB vs Saline Injection for TKA
Baseline characteristics by cohort
| Measure |
Group 1
n=2 Participants
Patient will receive genicular nerve block with bupivacaine
bupivacaine: Group 1 will receive genicular nerve block using bupivacaine
|
Group 2
Patient will receive normal saline as the nerve block
saline: Group 2 will receive genicular nerve block using normal saline
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.5 Years
n=99 Participants
|
—
|
71.5 Years
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
—
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
—
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
—
|
2 participants
n=206 Participants
|
|
Kilograms (kG) weight
|
95.8 Kilograms
n=99 Participants
|
—
|
95.8 Kilograms
n=206 Participants
|
|
Height Inches
|
66.5 Inches
n=99 Participants
|
—
|
66.5 Inches
n=206 Participants
|
|
Pre Surgical Baseline Pain at Rest
|
3 Units on a scale
n=99 Participants
|
—
|
3 Units on a scale
n=206 Participants
|
PRIMARY outcome
Timeframe: 36 hours after surgeryPopulation: Only two subjects enrolled both were randomized to group 1.
Post-operative opioid consumption measured in morphine milligram equivalents (MME)during the hospital stay up to 36 hours after surgery.
Outcome measures
| Measure |
Group 1
n=2 Participants
Patient will receive genicular nerve block with bupivacaine
bupivacaine: Group 1 will receive genicular nerve block using bupivacaine
|
Group 2
Patient will receive normal saline as the nerve block
saline: Group 2 will receive genicular nerve block using normal saline
|
|---|---|---|
|
Post-operative Opioid Consumption During the Hospital Stay
|
24.17 Morphine milligram equivalents (MME)
Interval 23.0 to 27.2
|
—
|
SECONDARY outcome
Timeframe: 48 hours after surgeryPopulation: Study terminated due to low enrollment. No subjects randomized to group 2.
Mean pain scores post operative reported using the VAS (visual analog scale) for knee pain at rest on a scale of 0 (no pain to 10 worst pain imaginable). This will be assessed every 6 hours up to 48 hours with the visual analog scale where 0 equals no pain and 10 represents excruciating pain.
Outcome measures
| Measure |
Group 1
n=2 Participants
Patient will receive genicular nerve block with bupivacaine
bupivacaine: Group 1 will receive genicular nerve block using bupivacaine
|
Group 2
Patient will receive normal saline as the nerve block
saline: Group 2 will receive genicular nerve block using normal saline
|
|---|---|---|
|
Mean Pain Scores of the Knee at Rest for the First 48 Hours After Surgery
|
3.05 score on a scale
Interval 2.6 to 3.5
|
—
|
SECONDARY outcome
Timeframe: 72 hours after surgeryPopulation: Study terminated early due to low enrollment. No subjects were randomized to group 2.
Overall satisfaction with pain control 72 hours after surgery using a visual analog scale where 0 = not satisfied and 10 being extremely satisfied
Outcome measures
| Measure |
Group 1
n=2 Participants
Patient will receive genicular nerve block with bupivacaine
bupivacaine: Group 1 will receive genicular nerve block using bupivacaine
|
Group 2
Patient will receive normal saline as the nerve block
saline: Group 2 will receive genicular nerve block using normal saline
|
|---|---|---|
|
Overall Satisfaction With Pain Control 72 Hours After Surgery
|
7 score on a scale
Interval 6.0 to 8.0
|
—
|
SECONDARY outcome
Timeframe: Admission to discharge from hospitalPopulation: Study was terminated early due to low enrollment. No subjects were randomized to group 2.
Length of hospitalization in hours from time to admission to time of discharge.
Outcome measures
| Measure |
Group 1
n=2 Participants
Patient will receive genicular nerve block with bupivacaine
bupivacaine: Group 1 will receive genicular nerve block using bupivacaine
|
Group 2
Patient will receive normal saline as the nerve block
saline: Group 2 will receive genicular nerve block using normal saline
|
|---|---|---|
|
Length of Hospitalization
|
38.29 Elapsed time in hours
Interval 30.57 to 46.0
|
—
|
Adverse Events
Group 1
Group 2
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1
n=2 participants at risk
Patient will receive genicular nerve block with bupivacaine
bupivacaine: Group 1 will receive genicular nerve block using bupivacaine
|
Group 2
Patient will receive normal saline as the nerve block
saline: Group 2 will receive genicular nerve block using normal saline
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Number of events 1 • 72 hours after surgical procedure.
The study was terminated early. No subjects were randomized to group 2.
|
—
0/0 • 72 hours after surgical procedure.
The study was terminated early. No subjects were randomized to group 2.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place