Trial Outcomes & Findings for Ropivacaine Versus Bupivacaine as Preemptive Analgesia in Surgical Site in Ankle Fracture Patients (NCT NCT02949674)
NCT ID: NCT02949674
Last Updated: 2018-12-31
Results Overview
The Pain will be measured with this scale from 0 (No pain) -10 (Worst pain possible) according to the investigator at 24 hours after surgery.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
93 participants
Primary outcome timeframe
Change in Visual Analogue Scale at 24 hours
Results posted on
2018-12-31
Participant Flow
Recruitment dates: January 2017 to April 2017, at High Specialty Unit Dr. Victorio de la Fuente Narvaez, IMSS
Participant milestones
| Measure |
Bupivacaine
It will be used bupivacaine in surgical site prior surgery (25 mg). At least 10 minutes before skin incision.
Bupivacaine: It will be used as a analgesic dose in surgical site before surgery.
|
Ropivacaine
It will be used ropivacaine in surgical site prior surgery (37.5 mg). At least 10 minutes before skin incision.
Ropivacaine: It will be used as a analgesic dose in surgical site before surgery.
|
Control
No application of anesthetic
|
|---|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
31
|
|
Overall Study
COMPLETED
|
31
|
31
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
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 |
Bupivacaine
n=31 Participants
It will be used bupivacaine in surgical site prior surgery (25 mg). At least 10 minutes before skin incision.
Bupivacaine: It will be used as a analgesic dose in surgical site before surgery.
|
Ropivacaine
n=31 Participants
It will be used ropivacaine in surgical site prior surgery (37.5 mg). At least 10 minutes before skin incision.
Ropivacaine: It will be used as a analgesic dose in surgical site before surgery.
|
Control
n=31 Participants
No application of anesthetic
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.3 years
n=31 Participants
|
37.16 years
n=31 Participants
|
33.71 years
n=31 Participants
|
37.7 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=31 Participants
|
18 Participants
n=31 Participants
|
17 Participants
n=31 Participants
|
51 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=31 Participants
|
13 Participants
n=31 Participants
|
14 Participants
n=31 Participants
|
42 Participants
n=93 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Mexico
|
31 participants
n=31 Participants
|
31 participants
n=31 Participants
|
31 participants
n=31 Participants
|
93 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Change in Visual Analogue Scale at 24 hoursThe Pain will be measured with this scale from 0 (No pain) -10 (Worst pain possible) according to the investigator at 24 hours after surgery.
Outcome measures
| Measure |
Bupivacaine
n=31 Participants
It will be used bupivacaine in surgical site prior surgery (25 mg). At least 10 minutes before skin incision.
Bupivacaine: It will be used as a analgesic dose in surgical site before surgery.
|
Ropivacaine
n=31 Participants
It will be used ropivacaine in surgical site prior surgery (37.5 mg). At least 10 minutes before skin incision.
Ropivacaine: It will be used as a analgesic dose in surgical site before surgery.
|
Control
n=31 Participants
No application of anesthetic
|
|---|---|---|---|
|
VAS
VAS at 4 hours
|
2.81 units on a scale (VAS)
Standard Deviation 1.302
|
2.13 units on a scale (VAS)
Standard Deviation 0.619
|
3.52 units on a scale (VAS)
Standard Deviation 1.387
|
|
VAS
VAS at 8 hours
|
4.52 units on a scale (VAS)
Standard Deviation 1.022
|
3.04 units on a scale (VAS)
Standard Deviation 1.113
|
5.02 units on a scale (VAS)
Standard Deviation 0.957
|
|
VAS
VAS at 12 hours
|
4.42 units on a scale (VAS)
Standard Deviation 0.765
|
3.55 units on a scale (VAS)
Standard Deviation 0.995
|
4.84 units on a scale (VAS)
Standard Deviation 1.061
|
|
VAS
VAS at 24 hours
|
4.03 units on a scale (VAS)
Standard Deviation 0.836
|
3.87 units on a scale (VAS)
Standard Deviation 0.783
|
4.10 units on a scale (VAS)
Standard Deviation 0.831
|
Adverse Events
Bupivacaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ropivacaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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