Trial Outcomes & Findings for Analgesic Value of Adductor Canal vs Femoral Block After Total Knee Arthroplasty (NCT NCT03395990)
NCT ID: NCT03395990
Last Updated: 2020-06-17
Results Overview
Pain intensity prior to intervention and at 5 minute intervals after intervention. The 11-point Numeric Rating Scale quantifies a subject's pain experience from 0/10 (no pain) to 10/10 (worst pain imaginable).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
Baseline, up to 30 minutes.
Results posted on
2020-06-17
Participant Flow
Participant milestones
| Measure |
Chloroprocaine
15 ml of 2% chloroprocaine via a femoral nerve block technique
Active comparator: chloroprocaine: 15 ml of 2% chloroprocaine was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb.
|
Saline
15 ml of 0.9% saline via a femoral nerve block technique
Sham comparator: saline: 15 ml of normal saline was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Analgesic Value of Adductor Canal vs Femoral Block After Total Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
Chloroprocaine
n=8 Participants
15 ml of 2% chloroprocaine via a femoral nerve block technique
Active comparator: chloroprocaine: 15 ml of 2% chloroprocaine was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb.
|
Saline
n=8 Participants
15 ml of 0.9% saline via a femoral nerve block technique
Sham comparator: saline: 15 ml of normal saline was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
n=99 Participants
|
68 years
n=107 Participants
|
68 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=99 Participants
|
8 participants
n=107 Participants
|
16 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, up to 30 minutes.Pain intensity prior to intervention and at 5 minute intervals after intervention. The 11-point Numeric Rating Scale quantifies a subject's pain experience from 0/10 (no pain) to 10/10 (worst pain imaginable).
Outcome measures
| Measure |
Chloroprocaine
n=8 Participants
15 ml of 2% chloroprocaine via a femoral nerve block technique
Active comparator: chloroprocaine: 15 ml of 2% chloroprocaine was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb.
|
Saline
n=8 Participants
15 ml of 0.9% saline via a femoral nerve block technique
Sham comparator: saline: 15 ml of normal saline was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb.
|
|---|---|---|
|
Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain.
20 minutes post-block
|
3.0 units on a scale
Interval 1.5 to 3.0
|
6.0 units on a scale
Interval 4.0 to 7.0
|
|
Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain.
Pre-block
|
7.0 units on a scale
Interval 5.5 to 8.0
|
6.0 units on a scale
Interval 6.0 to 7.5
|
|
Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain.
5 minutes post-block
|
4.0 units on a scale
Interval 2.5 to 6.0
|
6.0 units on a scale
Interval 5.5 to 7.0
|
|
Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain.
10 minutes post-block
|
4.0 units on a scale
Interval 2.0 to 5.0
|
6.5 units on a scale
Interval 6.0 to 8.0
|
|
Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain.
15 minutes post-block
|
3.2 units on a scale
Interval 2.0 to 4.5
|
6.5 units on a scale
Interval 4.5 to 7.0
|
|
Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain.
25 minutes post-block
|
3.0 units on a scale
Interval 1.5 to 3.0
|
5.5 units on a scale
Interval 4.0 to 7.0
|
|
Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain.
30 minutes post-block
|
2.0 units on a scale
Interval 1.5 to 2.8
|
5.5 units on a scale
Interval 4.0 to 6.5
|
Adverse Events
Chloroprocaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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