Trial Outcomes & Findings for Regional Block for Postoperative Free Flap Care (NCT NCT04080739)
NCT ID: NCT04080739
Last Updated: 2023-12-06
Results Overview
Opioid Utilization was measured by the number of mg of Oral Morphine Equivalent (oral pain medication) was given to patients.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
21 days
Results posted on
2023-12-06
Participant Flow
Participant milestones
| Measure |
Experimental Group
US-guided ipsilateral sciatic nerve block for fibula free flap patients utilizing ropivacaine 0.2% at 2-8 cc/hr for fibula free flap patients; US-guided infraclavicular brachial plexus nerve block for forearm free lap patients utilizing ropivacaine 0.2% at 2-8cc/hr for forearm free flap patients.
ropivicaine 0.2%: 2-8 cc/hr of 0.2% ropivicaine given as a regional block via US-guided ipsilateral sciatic nerve block for fibula free flap patients or US-guided infraclavicular brachial plexus nerve block for forearm free flap patients.
|
Control Group
No regional anesthetic of any kind during the surgical procedure.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
48
|
50
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental Group
n=48 Participants
US-guided ipsilateral sciatic nerve block for fibula free flap patients utilizing ropivacaine 0.2% at 2-8 cc/hr for fibula free flap patients; US-guided infraclavicular brachial plexus nerve block for forearm free lap patients utilizing ropivacaine 0.2% at 2-8cc/hr for forearm free flap patients.
ropivicaine 0.2%: 2-8 cc/hr of 0.2% ropivicaine given as a regional block via US-guided ipsilateral sciatic nerve block for fibula free flap patients or US-guided infraclavicular brachial plexus nerve block for forearm free flap patients.
|
Control Group
n=50 Participants
No regional anesthetic of any kind during the surgical procedure.
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=48 Participants
|
1 Participants
n=50 Participants
|
3 Participants
n=98 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
44 Participants
n=48 Participants
|
47 Participants
n=50 Participants
|
91 Participants
n=98 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=48 Participants
|
2 Participants
n=50 Participants
|
4 Participants
n=98 Participants
|
|
Age, Continuous
|
56 years
n=48 Participants
|
56 years
n=50 Participants
|
56 years
n=98 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=48 Participants
|
22 Participants
n=50 Participants
|
44 Participants
n=98 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=48 Participants
|
28 Participants
n=50 Participants
|
54 Participants
n=98 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 21 daysPopulation: Subjects included
Opioid Utilization was measured by the number of mg of Oral Morphine Equivalent (oral pain medication) was given to patients.
Outcome measures
| Measure |
Experimental Group
n=48 Participants
US-guided ipsilateral sciatic nerve block for fibula free flap patients utilizing ropivacaine 0.2% at 2-8 cc/hr for fibula free flap patients; US-guided infraclavicular brachial plexus nerve block for forearm free lap patients utilizing ropivacaine 0.2% at 2-8cc/hr for forearm free flap patients.
ropivicaine 0.2%: 2-8 cc/hr of 0.2% ropivicaine given as a regional block via US-guided ipsilateral sciatic nerve block for fibula free flap patients or US-guided infraclavicular brachial plexus nerve block for forearm free flap patients.
|
Control Group
n=50 Participants
No regional anesthetic of any kind during the surgical procedure.
|
|---|---|---|
|
Opioid Utilization Measured in Oral Morphine Equivalent (OME)
|
118 mg
Interval 19.81 to 217.05
|
166 mg
Interval 35.66 to 296.98
|
SECONDARY outcome
Timeframe: 21 daysAmount of opioid medication used post-operatively
Outcome measures
| Measure |
Experimental Group
n=48 Participants
US-guided ipsilateral sciatic nerve block for fibula free flap patients utilizing ropivacaine 0.2% at 2-8 cc/hr for fibula free flap patients; US-guided infraclavicular brachial plexus nerve block for forearm free lap patients utilizing ropivacaine 0.2% at 2-8cc/hr for forearm free flap patients.
ropivicaine 0.2%: 2-8 cc/hr of 0.2% ropivicaine given as a regional block via US-guided ipsilateral sciatic nerve block for fibula free flap patients or US-guided infraclavicular brachial plexus nerve block for forearm free flap patients.
|
Control Group
n=50 Participants
No regional anesthetic of any kind during the surgical procedure.
|
|---|---|---|
|
Opioid Medication Use
|
118 morphine milliequivalents
Standard Deviation 98.6
|
166 morphine milliequivalents
Standard Deviation 130.7
|
Adverse Events
Experimental Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control 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
Dr. Anthony Morlandt
University of Alabama at Birmingham
Phone: 205-996-2799
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place