Trial Outcomes & Findings for Study to Find Optimal Dose of Local Spinal Anesthetic (Mepivacaine) Combined With Narcotic (Fentanyl) For Knee Surgery (NCT NCT01701102)
NCT ID: NCT01701102
Last Updated: 2016-04-05
Results Overview
The time frame of the study for each patient only covers the period between time of surgery and time of discharge from the hospital, which is on the same day as the day of surgery
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
56 participants
Primary outcome timeframe
Participants will be followed for the duration of their recovery after surgery in the post-anesthesia care unit (PACU), an expected average of 2-4 hours.
Results posted on
2016-04-05
Participant Flow
Participant milestones
| Measure |
Mepivacaine 37.5 mg
Mepivacaine (37.5 mg)
|
Mepivacaine 30 mg Plus Fentanyl 10 µg
Mepivacaine plus fentanyl: Mepivacaine (30 mg) and fentanyl (10 µg)
|
Mepivacaine 27 mg Plus Fentanyl 10 µg
Mepivacaine plus fentanyl: Mepivacaine (27 mg) and fentanyl (10 µg)
|
Mepivacaine 24 mg Plus Fentanyl 10 µg
Mepivacaine plus fentanyl: Mepivacaine (24 mg) and fentanyl (10 µg)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
6
|
10
|
18
|
|
Overall Study
COMPLETED
|
22
|
6
|
10
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Find Optimal Dose of Local Spinal Anesthetic (Mepivacaine) Combined With Narcotic (Fentanyl) For Knee Surgery
Baseline characteristics by cohort
| Measure |
Mepivacaine 37.5 mg
n=22 Participants
Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
|
Mepivacaine 30 mg Plus Fentanyl 10 µg
n=6 Participants
Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
|
Mepivacaine 27 mg Plus Fentanyl 10 µg
n=10 Participants
Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
|
Mepivacaine 24 mg Plus Fentanyl 10 µg
n=18 Participants
Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
41 years
n=5 Participants
|
50 years
n=7 Participants
|
46 years
n=5 Participants
|
45 years
n=4 Participants
|
44 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Body Mass Index
|
26.3 kg/(m^2)
STANDARD_DEVIATION 3.8 • n=5 Participants
|
26.0 kg/(m^2)
STANDARD_DEVIATION 4.3 • n=7 Participants
|
28.5 kg/(m^2)
STANDARD_DEVIATION 5.6 • n=5 Participants
|
28.7 kg/(m^2)
STANDARD_DEVIATION 4.8 • n=4 Participants
|
27.4 kg/(m^2)
STANDARD_DEVIATION 4.6 • n=21 Participants
|
PRIMARY outcome
Timeframe: Participants will be followed for the duration of their recovery after surgery in the post-anesthesia care unit (PACU), an expected average of 2-4 hours.The time frame of the study for each patient only covers the period between time of surgery and time of discharge from the hospital, which is on the same day as the day of surgery
Outcome measures
| Measure |
Mepivacaine 37.5 mg
n=22 Participants
Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
|
Mepivacaine 30 mg Plus Fentanyl 10 µg
n=6 Participants
Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
|
Mepivacaine 27 mg Plus Fentanyl 10 µg
n=10 Participants
Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
|
Mepivacaine 24 mg Plus Fentanyl 10 µg
n=18 Participants
Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
|
|---|---|---|---|---|
|
Time From Spinal Administration to Block Regression to the S1 Dermatome in Post-Anesthesia Care Unit (PACU)
|
203 minutes
Interval 165.0 to 231.0
|
195 minutes
Interval 175.0 to 210.0
|
156 minutes
Interval 135.0 to 180.0
|
159 minutes
Interval 135.0 to 194.0
|
Adverse Events
Mepivacaine 37.5 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mepivacaine 30 mg Plus Fentanyl 10 µg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mepivacaine 27 mg Plus Fentanyl 10 µg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mepivacaine 24 mg Plus Fentanyl 10 µg
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