Trial Outcomes & Findings for The Efficacy and Safety of Local Anesthetic Infusion With Ropivacaine (NCT NCT00930046)
NCT ID: NCT00930046
Last Updated: 2020-04-28
Results Overview
Total amount of morphine used in the first 48hrs immediately after surgery
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
48 hours
Results posted on
2020-04-28
Participant Flow
Participant milestones
| Measure |
Ropivacaine Group
Patients in this group will receive ropivacaine via the wound catheter for the first 48hrs after surgery
Wound catheter: 19 gauge fenestrated wound catheter inserted into the fascial planes of the surgical site prior to skin closure with a separate exit site.
|
Normal Saline Group
Will receive an infusion of normal saline for 48hrs post-operatively via the wound catheter.
wound catheter: 19 gauge fenestrated wound catheter will be inserted into the fascial planes of the surgical site prior to wound closure
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
|
Overall Study
COMPLETED
|
7
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Ropivacaine Group
Patients in this group will receive ropivacaine via the wound catheter for the first 48hrs after surgery
Wound catheter: 19 gauge fenestrated wound catheter inserted into the fascial planes of the surgical site prior to skin closure with a separate exit site.
|
Normal Saline Group
Will receive an infusion of normal saline for 48hrs post-operatively via the wound catheter.
wound catheter: 19 gauge fenestrated wound catheter will be inserted into the fascial planes of the surgical site prior to wound closure
|
|---|---|---|
|
Overall Study
Wound catheter malfunctioned
|
1
|
2
|
Baseline Characteristics
The Efficacy and Safety of Local Anesthetic Infusion With Ropivacaine
Baseline characteristics by cohort
| Measure |
Normal Saline Group
n=7 Participants
Will receive an infusion of normal saline for 48hrs post-operatively via the wound catheter.
Saline wound catheter: 19 gauge fenestrated wound catheter will be inserted into the fascial planes of the surgical site prior to wound closure
|
Total
n=15 Participants
Total of all reporting groups
|
Ropivacaine Group
n=8 Participants
Patients in this group will receive ropivacaine via the wound catheter for the first 48hrs after surgery
Ropivacaine wound catheter: 19 gauge fenestrated wound catheter inserted into the fascial planes of the surgical site prior to skin closure with a separate exit site.
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 hoursTotal amount of morphine used in the first 48hrs immediately after surgery
Outcome measures
| Measure |
Ropivacaine Group
n=7 Participants
Patients in this group will receive ropivacaine via the wound catheter for the first 48hrs after surgery
Wound catheter: 19 gauge fenestrated wound catheter inserted into the fascial planes of the surgical site prior to skin closure with a separate exit site.
|
Normal Saline Group
n=5 Participants
Will receive an infusion of normal saline for 48hrs post-operatively via the wound catheter.
wound catheter: 19 gauge fenestrated wound catheter will be inserted into the fascial planes of the surgical site prior to wound closure
|
|---|---|---|
|
Morphine
|
2.2 mg/kg per 48 hours
Standard Deviation 1.8
|
3.5 mg/kg per 48 hours
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: 48 hours post-operativelyObservational FLACC pain intensity assessment tool that consists of observing the Faces Legs Activity Cry Consolability (FLACC) by the bedside nursing staff. This pain assessment tool is validated in non-verbal children and children at 7 years and younger. Minimum value is 0 and the maximum value is 10, where 0 represents no pain which is a better outcome.
Outcome measures
| Measure |
Ropivacaine Group
n=7 Participants
Patients in this group will receive ropivacaine via the wound catheter for the first 48hrs after surgery
Wound catheter: 19 gauge fenestrated wound catheter inserted into the fascial planes of the surgical site prior to skin closure with a separate exit site.
|
Normal Saline Group
n=5 Participants
Will receive an infusion of normal saline for 48hrs post-operatively via the wound catheter.
wound catheter: 19 gauge fenestrated wound catheter will be inserted into the fascial planes of the surgical site prior to wound closure
|
|---|---|---|
|
FLACC Pain Intensity [Faces Legs Activity Cry Consolability] 0-10 Points
|
1.3 score on a scale
Standard Deviation 0.7
|
1.9 score on a scale
Standard Deviation 1.8
|
Adverse Events
Ropivacaine Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Saline Group
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