Trial Outcomes & Findings for Infrapatellar Nerve Block for Post-operative Knee Arthroscopy Pain Control (NCT NCT01279447)
NCT ID: NCT01279447
Last Updated: 2014-05-12
Results Overview
immediate postop pain score, Visual Analog Scale. Evaluates pain on scale from 0-10. 0=no pain. 10=maximum pain.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
68 participants
Primary outcome timeframe
0 hours
Results posted on
2014-05-12
Participant Flow
Participant milestones
| Measure |
Placebo
A sham infrapatellar block performed under US guidance with normal saline
Normal Saline: 10cc, single dose, US guided injection
|
Infrapatellar Nerve Block
An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine
0.25% Bupivacaine: 10cc, single dose, US guided injection
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
34
|
|
Overall Study
COMPLETED
|
31
|
33
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Placebo
A sham infrapatellar block performed under US guidance with normal saline
Normal Saline: 10cc, single dose, US guided injection
|
Infrapatellar Nerve Block
An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine
0.25% Bupivacaine: 10cc, single dose, US guided injection
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
Baseline Characteristics
Infrapatellar Nerve Block for Post-operative Knee Arthroscopy Pain Control
Baseline characteristics by cohort
| Measure |
Placebo
n=34 Participants
A sham infrapatellar block performed under US guidance with normal saline
Normal Saline: 10cc, single dose, US guided injection
|
Infrapatellar Nerve Block
n=34 Participants
An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine
0.25% Bupivacaine: 10cc, single dose, US guided injection
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.6 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
51.7 years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
50.6 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 hoursimmediate postop pain score, Visual Analog Scale. Evaluates pain on scale from 0-10. 0=no pain. 10=maximum pain.
Outcome measures
| Measure |
Placebo
n=34 Participants
A sham infrapatellar block performed under US guidance with normal saline
Normal Saline: 10cc, single dose, US guided injection
|
Infrapatellar Nerve Block
n=34 Participants
An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine
0.25% Bupivacaine: 10cc, single dose, US guided injection
|
|---|---|---|
|
Post op Pain Score
|
5.5 units on a scale
Standard Deviation 2.6
|
3.9 units on a scale
Standard Deviation 3.3
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Infrapatellar Nerve Block
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