Trial Outcomes & Findings for PROPER Trial of Pain and Inflammation After Knee Arthroscopy (NCT NCT05149287)
NCT ID: NCT05149287
Last Updated: 2023-09-05
Results Overview
The Visual analog scale scores range from 0 to 10 with greater scores indicative of greater pain.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Pre-operative, 2 months post-operative
Results posted on
2023-09-05
Participant Flow
Participant milestones
| Measure |
Experimental
The experimental group will receive a single intravenous dose of 1 g of ceftriaxone immediately postoperative in the operating room.
Ceftriaxone: single intravenous dose of 1 g of ceftriaxone
|
Placebo
The placebo group will receive a single intravenous dose of 1% lidocaine and saline immediately postoperative in the operating room.
Placebo: 1% lidocaine and saline
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PROPER Trial of Pain and Inflammation After Knee Arthroscopy
Baseline characteristics by cohort
| Measure |
Experimental
n=3 Participants
The experimental group will receive a single intravenous dose of 1 g of ceftriaxone immediately postoperative in the operating room.
Ceftriaxone: single intravenous dose of 1 g of ceftriaxone
|
Placebo
n=2 Participants
The placebo group will receive a single intravenous dose of 1% lidocaine and saline immediately postoperative in the operating room.
Placebo: 1% lidocaine and saline
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.7 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
45.5 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
43.8 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-operative, 2 months post-operativeThe Visual analog scale scores range from 0 to 10 with greater scores indicative of greater pain.
Outcome measures
| Measure |
Experimental
n=3 Participants
The experimental group will receive a single intravenous dose of 1 g of ceftriaxone immediately postoperative in the operating room.
Ceftriaxone: single intravenous dose of 1 g of ceftriaxone
|
Placebo
n=2 Participants
The placebo group will receive a single intravenous dose of 1% lidocaine and saline immediately postoperative in the operating room.
Placebo: 1% lidocaine and saline
|
|---|---|---|
|
Change in Visual Analog Scale (VAS) Pain Score
|
-2.67 units on a scale
Standard Deviation 1.11
|
-2.1 units on a scale
Standard Deviation 2.97
|
PRIMARY outcome
Timeframe: Pre-operative, 2 months post-operativeThe Regularity, Sleep Quality, Alertness, Timing, Efficiency, Duration scale for sleep (RU SATED) ranges from 0 to 30, with higher scores indicating better sleep health.
Outcome measures
| Measure |
Experimental
n=3 Participants
The experimental group will receive a single intravenous dose of 1 g of ceftriaxone immediately postoperative in the operating room.
Ceftriaxone: single intravenous dose of 1 g of ceftriaxone
|
Placebo
n=2 Participants
The placebo group will receive a single intravenous dose of 1% lidocaine and saline immediately postoperative in the operating room.
Placebo: 1% lidocaine and saline
|
|---|---|---|
|
Change in RU SATED Score
|
1 units on a scale
Standard Deviation 0
|
-0.5 units on a scale
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: 5-12 days post-operativePost-operative narcotic use will be monitored with self-reported medication consumption at the first post-operative visit, which will take place 5-12 days post-operative. The milligrams of morphine equivalent (MME) will be calculated based on patient responses with greater MME indicative of increased postoperative use of narcotic pain medications.
Outcome measures
| Measure |
Experimental
n=3 Participants
The experimental group will receive a single intravenous dose of 1 g of ceftriaxone immediately postoperative in the operating room.
Ceftriaxone: single intravenous dose of 1 g of ceftriaxone
|
Placebo
n=2 Participants
The placebo group will receive a single intravenous dose of 1% lidocaine and saline immediately postoperative in the operating room.
Placebo: 1% lidocaine and saline
|
|---|---|---|
|
Post-operative Narcotic Use
|
15 milligrams of morphine equivalent (MME)
Standard Deviation 4.4
|
5.5 milligrams of morphine equivalent (MME)
Standard Deviation 2.1
|
Adverse Events
Experimental
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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