Trial Outcomes & Findings for Analgesia After Total Hip Arthroplasty: Peri-Articular Injection Versus Epidural Patient Controlled Analgesia (PCA) (NCT NCT01658072)
NCT ID: NCT01658072
Last Updated: 2022-04-14
Results Overview
"readiness for discharge" to home or to a rehabilitation facility (compared to the HSS standard regimen of epidural analgesia) after total hip arthroplasty.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
Length of Hospital Stay, an expected average of 3 days
Results posted on
2022-04-14
Participant Flow
Participant milestones
| Measure |
Peri-Articular Injection
Peri-Articular Injection: Use of a different analgesic protocol, based on a peri-articular injection
|
Epidural Patient Controlled Analgesia (Epidural PCA)
Epidural Patient Controlled Analgesia (Epidural PCA): Epidural analgesia pathway.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
45
|
|
Overall Study
COMPLETED
|
41
|
43
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Peri-Articular Injection
Peri-Articular Injection: Use of a different analgesic protocol, based on a peri-articular injection
|
Epidural Patient Controlled Analgesia (Epidural PCA)
Epidural Patient Controlled Analgesia (Epidural PCA): Epidural analgesia pathway.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
4
|
2
|
Baseline Characteristics
Analgesia After Total Hip Arthroplasty: Peri-Articular Injection Versus Epidural Patient Controlled Analgesia (PCA)
Baseline characteristics by cohort
| Measure |
Peri-Articular Injection
n=41 Participants
Peri-Articular Injection: Use of a different analgesic protocol, based on a peri-articular injection
|
Epidural Patient Controlled Analgesia (Epidural PCA)
n=43 Participants
Epidural Patient Controlled Analgesia (Epidural PCA): Epidural analgesia pathway.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
64.8 years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
64.3 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
43 participants
n=7 Participants
|
84 participants
n=5 Participants
|
|
Body mass index
|
28.0 kg/(m^2)
STANDARD_DEVIATION 5.4 • n=5 Participants
|
27.9 kg/(m^2)
STANDARD_DEVIATION 6.2 • n=7 Participants
|
28.0 kg/(m^2)
STANDARD_DEVIATION 5.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: Length of Hospital Stay, an expected average of 3 days"readiness for discharge" to home or to a rehabilitation facility (compared to the HSS standard regimen of epidural analgesia) after total hip arthroplasty.
Outcome measures
| Measure |
Peri-Articular Injection
n=41 Participants
Peri-Articular Injection: Use of a different analgesic protocol, based on a peri-articular injection
|
Epidural Patient Controlled Analgesia (Epidural PCA)
n=43 Participants
Epidural Patient Controlled Analgesia (Epidural PCA): Epidural analgesia pathway.
|
|---|---|---|
|
Time Until Patient is Ready for Discharge
|
2.4 days
Standard Deviation 0.7
|
2.3 days
Standard Deviation 0.8
|
Adverse Events
Peri-Articular Injection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Epidural Patient Controlled Analgesia (Epidural PCA)
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