Trial Outcomes & Findings for "Comparison of Intra-articular of 0.2% Ropivacaine vs. 0.75% Ropivacaine in Postoperative of Knee Arthroscopy" (NCT NCT05807945)
NCT ID: NCT05807945
Last Updated: 2024-10-15
Results Overview
The result is quantified continuously in a scale from 0 (No pain) to 10 (Worst pain imaginable) points. Acute pain is labeled of a value ≥4 points.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
70 participants
Primary outcome timeframe
2 hours postoperative
Results posted on
2024-10-15
Participant Flow
Participant milestones
| Measure |
Ropivacaine 0.75% Injectable Solution
The patients receive 10 ml of intraarticular solution in the knee (at the anatomical point at the level of the upper pole of the ball joint, under the iliotibial band), with different content of ropivacaine 0.75%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.
Ropivacaine 0.75% Injectable Solution: The patients receive 10 ml of intraarticular solution in the knee (at the anatomical point at the level of the upper pole of the ball joint, under the iliotibial band), with different content of ropivacaine 0.75%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.
|
Ropivacaine 0.2% Injectable Solution
The patients receive 10 ml of intraarticular solution in the knee (at the anatomical point at the level of the upper pole of the ball joint, under the iliotibial band), with different content of ropivacaine 0.2%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.
Ropivacaine 0.2% Injectable Solution: The patients receive 10 ml of intraarticular solution in the knee (at the anatomical point at the level of the upper pole of the ball joint, under the iliotibial band), with different content of ropivacaine 0.2%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
34
|
|
Overall Study
COMPLETED
|
36
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
"Comparison of Intra-articular of 0.2% Ropivacaine vs. 0.75% Ropivacaine in Postoperative of Knee Arthroscopy"
Baseline characteristics by cohort
| Measure |
Total
n=70 Participants
Total of all reporting groups
|
Ropivacaine 0.75% Injectable Solution
n=36 Participants
The patients receive 10 ml of intraarticular solution in the knee (at the anatomical point at the level of the upper pole of the ball joint, under the iliotibial band), with different content of ropivacaine 0.75%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.
Ropivacaine 0.75% Injectable Solution: The patients receive 10 ml of intraarticular solution in the knee (at the anatomical point at the level of the upper pole of the ball joint, under the iliotibial band), with different content of ropivacaine 0.75%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.
|
Ropivacaine 0.2% Injectable Solution
n=34 Participants
The patients receive 10 ml of intraarticular solution in the knee (at the anatomical point at the level of the upper pole of the ball joint, under the iliotibial band), with different content of ropivacaine 0.2%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.
Ropivacaine 0.2% Injectable Solution: The patients receive 10 ml of intraarticular solution in the knee (at the anatomical point at the level of the upper pole of the ball joint, under the iliotibial band), with different content of ropivacaine 0.2%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
70 Participants
n=206 Participants
|
36 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
|
Age, Continuous
|
39 years
STANDARD_DEVIATION 11 • n=206 Participants
|
40 years
STANDARD_DEVIATION 12 • n=99 Participants
|
38 years
STANDARD_DEVIATION 11 • n=107 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=206 Participants
|
25 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=206 Participants
|
11 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
|
Race/Ethnicity, Customized
Latin American
|
70 Participants
n=206 Participants
|
36 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
|
Region of Enrollment
Mexico
|
70 participants
n=206 Participants
|
36 participants
n=99 Participants
|
34 participants
n=107 Participants
|
|
Body Mass Index
<25 kg/m²
|
35 Participants
n=206 Participants
|
18 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
|
Body Mass Index
OVERWEIGHT (25 kg/m² or more)
|
35 Participants
n=206 Participants
|
18 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
|
Time of articular cartilage lesion evolution
<14 days
|
59 Participants
n=206 Participants
|
31 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
|
Time of articular cartilage lesion evolution
>14 days
|
11 Participants
n=206 Participants
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
|
Physical Activity
Sedentary
|
51 Participants
n=206 Participants
|
29 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
|
Physical Activity
Active
|
19 Participants
n=206 Participants
|
7 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
|
Etiology of surgery
Trauma
|
55 Participants
n=206 Participants
|
26 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
|
Etiology of surgery
Degenerative
|
15 Participants
n=206 Participants
|
10 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
|
Outerbridge Clasification
I (Softening or swelling of the cartilage, without visible fissures or fragmentation).
|
23 Participants
n=206 Participants
|
16 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
|
Outerbridge Clasification
II (Fissures less than 50% of the cartilage thickness, 1 mm or less in depth)
|
34 Participants
n=206 Participants
|
15 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
|
Outerbridge Clasification
III (Fissures extending more than 50% of the cartilage thickness but without full loss, 1-2 mm)
|
13 Participants
n=206 Participants
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
PRIMARY outcome
Timeframe: 2 hours postoperativeThe result is quantified continuously in a scale from 0 (No pain) to 10 (Worst pain imaginable) points. Acute pain is labeled of a value ≥4 points.
Outcome measures
| Measure |
Ropivacaine 0.75% Injectable Solution
n=36 Participants
The patients receive 10 ml of intraarticular solution in the knee (at the anatomical point at the level of the upper pole of the ball joint, under the iliotibial band), with different content of ropivacaine 0.75%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.
Ropivacaine 0.75% Injectable Solution: The patients receive 10 ml of intraarticular solution in the knee (at the anatomical point at the level of the upper pole of the ball joint, under the iliotibial band), with different content of ropivacaine 0.75%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.
|
Ropivacaine 0.2% Injectable Solution
n=34 Participants
The patients receive 10 ml of intraarticular solution in the knee (at the anatomical point at the level of the upper pole of the ball joint, under the iliotibial band), with different content of ropivacaine 0.2%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.
Ropivacaine 0.2% Injectable Solution: The patients receive 10 ml of intraarticular solution in the knee (at the anatomical point at the level of the upper pole of the ball joint, under the iliotibial band), with different content of ropivacaine 0.2%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.
|
|---|---|---|
|
Number of Participants With Acute Pain (Visual Analogue Scale)
|
10 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: 2 hours postoperativeThe administration of opioids in the first two hours of postoperative for necessary reasons (pain ≥4 points) is recorded by the physician in charge.
Outcome measures
| Measure |
Ropivacaine 0.75% Injectable Solution
n=36 Participants
The patients receive 10 ml of intraarticular solution in the knee (at the anatomical point at the level of the upper pole of the ball joint, under the iliotibial band), with different content of ropivacaine 0.75%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.
Ropivacaine 0.75% Injectable Solution: The patients receive 10 ml of intraarticular solution in the knee (at the anatomical point at the level of the upper pole of the ball joint, under the iliotibial band), with different content of ropivacaine 0.75%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.
|
Ropivacaine 0.2% Injectable Solution
n=34 Participants
The patients receive 10 ml of intraarticular solution in the knee (at the anatomical point at the level of the upper pole of the ball joint, under the iliotibial band), with different content of ropivacaine 0.2%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.
Ropivacaine 0.2% Injectable Solution: The patients receive 10 ml of intraarticular solution in the knee (at the anatomical point at the level of the upper pole of the ball joint, under the iliotibial band), with different content of ropivacaine 0.2%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.
|
|---|---|---|
|
Number of Participants With Opioid Administration
|
7 Participants
|
12 Participants
|
Adverse Events
Ropivacaine 0.75% Injectable Solution
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ropivacaine 0.2% Injectable Solution
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