Trial Outcomes & Findings for Combination of Peripheral Nerve Block and DepoDur in Total Knee Joint Replacement (NCT NCT00895531)
NCT ID: NCT00895531
Last Updated: 2017-07-27
Results Overview
Pain as reported on a verbal rating scale ( VRS) (0-10, 0 = no pain, 10 = worse pain imaginable).
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
75 participants
Primary outcome timeframe
48 hours
Results posted on
2017-07-27
Participant Flow
Participant milestones
| Measure |
Peripheral Nerve Group
|
Depodur Group
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
37
|
|
Overall Study
COMPLETED
|
38
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Peripheral Nerve Group
n=38 Participants
|
Depodur Group
n=37 Participants
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=38 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=75 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=38 Participants
|
37 Participants
n=37 Participants
|
75 Participants
n=75 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=38 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=75 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=38 Participants
|
9 Participants
n=37 Participants
|
15 Participants
n=75 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=38 Participants
|
28 Participants
n=37 Participants
|
60 Participants
n=75 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 48 hoursPain as reported on a verbal rating scale ( VRS) (0-10, 0 = no pain, 10 = worse pain imaginable).
Outcome measures
| Measure |
Peripheral Nerve Group
n=38 Participants
|
Depodur Group
n=37 Participants
|
|---|---|---|
|
Postoperative Pain
|
5 units on a scale
Standard Deviation 3
|
6 units on a scale
Standard Deviation 2
|
Adverse Events
Peripheral Nerve Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Depodur Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Peripheral Nerve Group
n=38 participants at risk
|
Depodur Group
n=37 participants at risk
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.00%
0/38
|
2.7%
1/37 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place