Trial Outcomes & Findings for Randomized Trial of Ropivacaine & Bupivacaine for Inflatable Penile Prosthesis (NCT NCT04801368)
NCT ID: NCT04801368
Last Updated: 2025-02-04
Results Overview
Visual-analogue pain scale is a tool used to measure pain intensity at a specific timepoint, asking a patient to use visuals to rate their pain on a scale of 1 to 10. Results are reported as units on a scale, minimum 1 (experiencing the least amount of pain possible) to maximum of 10 (experiencing an unbearably high amount of pain). Lower scores provide a better outcome for the patient as they are experiencing less pain post-operatively.
COMPLETED
PHASE4
20 participants
post-operative day 3
2025-02-04
Participant Flow
Participant milestones
| Measure |
Receiving Ropivacaine
Patients receiving Ropivacaine intra-operatively.
Randomization of two local anesthetics.: Patients will be blinded and randomized to two different arms. One receiving ropivacaine, one receiving liposomal bupivacaine.
Dosage depends on subjects height, weight, and other health factors
|
Receiving Liposomal Bupivacaine
Patients receiving Liposomal Bupivacaine intra-operatively.
Randomization of two local anesthetics.: Patients will be blinded and randomized to two different arms. One receiving ropivacaine, one receiving liposomal bupivacaine.
Dosage depends on subjects height, weight, and other health factors
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
14
|
|
Overall Study
COMPLETED
|
5
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Trial of Ropivacaine & Bupivacaine for Inflatable Penile Prosthesis
Baseline characteristics by cohort
| Measure |
Receiving Ropivacaine
n=5 Participants
Patients receiving Ropivacaine.
Randomization of two local anesthetics.: Patients will be blinded and randomized to two different arms. One receiving ropivacaine, one receiving liposomal bupivacaine.
|
Receiving Liposomal Bupivacaine
n=14 Participants
Patients receiving Liposomal Bupivacaine.
Randomization of two local anesthetics.: Patients will be blinded and randomized to two different arms. One receiving ropivacaine, one receiving liposomal bupivacaine.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 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
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
14 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
State Trait Anxiety Inventory
|
27 units on a scale
STANDARD_DEVIATION 12.96 • n=5 Participants
|
30.3 units on a scale
STANDARD_DEVIATION 11.24 • n=7 Participants
|
29.39 units on a scale
STANDARD_DEVIATION 11.44 • n=5 Participants
|
|
Pain Catastrophizing Scale
|
1.6 units on a scale
STANDARD_DEVIATION 2.07 • n=5 Participants
|
4.08 units on a scale
STANDARD_DEVIATION 5.75 • n=7 Participants
|
3.39 units on a scale
STANDARD_DEVIATION 5.07 • n=5 Participants
|
PRIMARY outcome
Timeframe: post-operative day 3Visual-analogue pain scale is a tool used to measure pain intensity at a specific timepoint, asking a patient to use visuals to rate their pain on a scale of 1 to 10. Results are reported as units on a scale, minimum 1 (experiencing the least amount of pain possible) to maximum of 10 (experiencing an unbearably high amount of pain). Lower scores provide a better outcome for the patient as they are experiencing less pain post-operatively.
Outcome measures
| Measure |
Receiving Ropivacaine
n=5 Participants
Patients receiving Ropivacaine.
Randomization of two local anesthetics.: Patients will be blinded and randomized to two different arms. One receiving ropivacaine, one receiving liposomal bupivacaine.
|
Receiving Liposomal Bupivacaine
n=14 Participants
Patients receiving Liposomal Bupivacaine.
Randomization of two local anesthetics.: Patients will be blinded and randomized to two different arms. One receiving ropivacaine, one receiving liposomal bupivacaine.
|
|---|---|---|
|
Visual-analogue Pain Scale
|
6 units on a scale
Interval 4.0 to 8.0
|
4 units on a scale
Interval 1.0 to 7.0
|
PRIMARY outcome
Timeframe: post-operative day 7Visual-analogue pain scale is a tool used to measure pain intensity at a specific timepoint, asking a patient to use visuals to rate their pain on a scale of 1 to 10. Results are reported as units on a scale, minimum 1 (experiencing the least amount of pain possible) to maximum of 10 (experiencing an unbearably high amount of pain). Lower scores provide a better outcome for the patient as they are experiencing less pain post-operatively.
Outcome measures
| Measure |
Receiving Ropivacaine
n=5 Participants
Patients receiving Ropivacaine.
Randomization of two local anesthetics.: Patients will be blinded and randomized to two different arms. One receiving ropivacaine, one receiving liposomal bupivacaine.
|
Receiving Liposomal Bupivacaine
n=14 Participants
Patients receiving Liposomal Bupivacaine.
Randomization of two local anesthetics.: Patients will be blinded and randomized to two different arms. One receiving ropivacaine, one receiving liposomal bupivacaine.
|
|---|---|---|
|
Visual-analogue Pain Scale
|
6 units on a scale
Interval 3.0 to 9.0
|
4.1 units on a scale
Interval 1.0 to 7.0
|
PRIMARY outcome
Timeframe: post-operative day 14Visual-analogue pain scale is a tool used to measure pain intensity at a specific timepoint, asking a patient to use visuals to rate their pain on a scale of 1 to 10. Results are reported as units on a scale, minimum 1 (experiencing the least amount of pain possible) to maximum of 10 (experiencing an unbearably high amount of pain). Lower scores provide a better outcome for the patient as they are experiencing less pain post-operatively.
Outcome measures
| Measure |
Receiving Ropivacaine
n=5 Participants
Patients receiving Ropivacaine.
Randomization of two local anesthetics.: Patients will be blinded and randomized to two different arms. One receiving ropivacaine, one receiving liposomal bupivacaine.
|
Receiving Liposomal Bupivacaine
n=14 Participants
Patients receiving Liposomal Bupivacaine.
Randomization of two local anesthetics.: Patients will be blinded and randomized to two different arms. One receiving ropivacaine, one receiving liposomal bupivacaine.
|
|---|---|---|
|
Visual-analogue Pain Scale
|
2.8 units on a scale
Interval 1.0 to 5.0
|
3.56 units on a scale
Interval 1.0 to 6.0
|
PRIMARY outcome
Timeframe: post-operative day 3Visual-analogue anxiety scale is a tool used to measure anxiety intensity at a specific timepoint, asking a patient to use visuals to rate their current anxiety on a scale of 1 to 10. Results are reported as units on a scale, minimum 1 (experiencing the least amount of anxiety possible) to maximum of 10 (experiencing an unbearably high amount of anxiety). Lower scores provide a better outcome for the patient as they are experiencing less anxiety post-operatively.
Outcome measures
| Measure |
Receiving Ropivacaine
n=5 Participants
Patients receiving Ropivacaine.
Randomization of two local anesthetics.: Patients will be blinded and randomized to two different arms. One receiving ropivacaine, one receiving liposomal bupivacaine.
|
Receiving Liposomal Bupivacaine
n=14 Participants
Patients receiving Liposomal Bupivacaine.
Randomization of two local anesthetics.: Patients will be blinded and randomized to two different arms. One receiving ropivacaine, one receiving liposomal bupivacaine.
|
|---|---|---|
|
Visual-analogue Anxiety Scale
|
4 units on a scale
Interval 2.0 to 6.0
|
2.43 units on a scale
Interval 1.0 to 6.0
|
PRIMARY outcome
Timeframe: post-operative day 7Visual-analogue anxiety scale is a tool used to measure anxiety intensity at a specific timepoint, asking a patient to use visuals to rate their current anxiety on a scale of 1 to 10. Results are reported as units on a scale, minimum 1 (experiencing the least amount of anxiety possible) to maximum of 10 (experiencing an unbearably high amount of anxiety). Lower scores provide a better outcome for the patient as they are experiencing less anxiety post-operatively.
Outcome measures
| Measure |
Receiving Ropivacaine
n=5 Participants
Patients receiving Ropivacaine.
Randomization of two local anesthetics.: Patients will be blinded and randomized to two different arms. One receiving ropivacaine, one receiving liposomal bupivacaine.
|
Receiving Liposomal Bupivacaine
n=14 Participants
Patients receiving Liposomal Bupivacaine.
Randomization of two local anesthetics.: Patients will be blinded and randomized to two different arms. One receiving ropivacaine, one receiving liposomal bupivacaine.
|
|---|---|---|
|
Visual-analogue Anxiety Scale
|
4 units on a scale
Interval 1.0 to 7.0
|
2.22 units on a scale
Interval 1.0 to 5.0
|
PRIMARY outcome
Timeframe: post-operative day 14Visual-analogue anxiety scale is a tool used to measure anxiety intensity at a specific timepoint, asking a patient to use visuals to rate their current anxiety on a scale of 1 to 10. Results are reported as units on a scale, minimum 1 (experiencing the least amount of anxiety possible) to maximum of 10 (experiencing an unbearably high amount of anxiety). Lower scores provide a better outcome for the patient as they are experiencing less anxiety post-operatively.
Outcome measures
| Measure |
Receiving Ropivacaine
n=5 Participants
Patients receiving Ropivacaine.
Randomization of two local anesthetics.: Patients will be blinded and randomized to two different arms. One receiving ropivacaine, one receiving liposomal bupivacaine.
|
Receiving Liposomal Bupivacaine
n=14 Participants
Patients receiving Liposomal Bupivacaine.
Randomization of two local anesthetics.: Patients will be blinded and randomized to two different arms. One receiving ropivacaine, one receiving liposomal bupivacaine.
|
|---|---|---|
|
Visual-analogue Anxiety Scale
|
2 units on a scale
Interval 1.0 to 3.0
|
2.44 units on a scale
Interval 1.0 to 6.0
|
Adverse Events
Receiving Ropivacaine
Receiving Liposomal Bupivacaine
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