Trial Outcomes & Findings for Femoral Peri-arterial Local Anesthetic Injection Decreases Tourniquet Associated Ischemic Hypertension (NCT NCT03390426)
NCT ID: NCT03390426
Last Updated: 2021-05-05
Results Overview
Measuring systolic blood pressure using a cuff, aim to keep \<30mmHg change from baseline
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
31 participants
Primary outcome timeframe
Intraoperatively (~3 hours)
Results posted on
2021-05-05
Participant Flow
Participant milestones
| Measure |
Mepivacaine Block Group
Injection of local anesthetic (mepivacaine) above and beside the femoral artery.
Mepivacaine: An ultrasound guided injection of mepivacaine superomedially to the femoral artery.
Perifemoral Injection of Local Anesthetic: An ultrasound guided injection of mepivacaine superomedially to the formal artery in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.
|
Saline Sham Group
Injection of salt water (saline) above and beside the femoral artery.
Perifemoral Injection of Local Anesthetic: An ultrasound guided injection of mepivacaine superomedially to the formal artery in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.
Saline: An ultrasound guided injection using a medication that does NOT numb any nerves called saline, or salt water.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
16
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Mepivacaine Block Group
Injection of local anesthetic (mepivacaine) above and beside the femoral artery.
Mepivacaine: An ultrasound guided injection of mepivacaine superomedially to the femoral artery.
Perifemoral Injection of Local Anesthetic: An ultrasound guided injection of mepivacaine superomedially to the formal artery in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.
|
Saline Sham Group
Injection of salt water (saline) above and beside the femoral artery.
Perifemoral Injection of Local Anesthetic: An ultrasound guided injection of mepivacaine superomedially to the formal artery in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.
Saline: An ultrasound guided injection using a medication that does NOT numb any nerves called saline, or salt water.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Femoral Peri-arterial Local Anesthetic Injection Decreases Tourniquet Associated Ischemic Hypertension
Baseline characteristics by cohort
| Measure |
Mepivacaine Block Group
n=15 Participants
Injection of local anesthetic (mepivacaine) above and beside the femoral artery.
Mepivacaine: An ultrasound guided injection of mepivacaine superomedially to the femoral artery.
Perifemoral Injection of Local Anesthetic: An ultrasound guided injection of mepivacaine superomedially to the formal artery in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.
|
Saline Sham Group
n=15 Participants
Injection of salt water (saline) above and beside the femoral artery.
Perifemoral Injection of Local Anesthetic: An ultrasound guided injection of mepivacaine superomedially to the formal artery in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.
Saline: An ultrasound guided injection using a medication that does NOT numb any nerves called saline, or salt water.
|
Total
n=30 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
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Continuous
|
60.47 years
STANDARD_DEVIATION 11.84 • n=5 Participants
|
65.67 years
STANDARD_DEVIATION 4.61 • n=7 Participants
|
63.81 years
STANDARD_DEVIATION 9.95 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 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
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
ASA Status
ASA 1
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
ASA Status
ASA 2
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
ASA Status
ASA 3
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
31.11 kg/m^2
STANDARD_DEVIATION 4.63 • n=5 Participants
|
32.64 kg/m^2
STANDARD_DEVIATION 5.41 • n=7 Participants
|
31.63 kg/m^2
STANDARD_DEVIATION 5.11 • n=5 Participants
|
PRIMARY outcome
Timeframe: Intraoperatively (~3 hours)Population: Subjects who completed the study.
Measuring systolic blood pressure using a cuff, aim to keep \<30mmHg change from baseline
Outcome measures
| Measure |
Mepivacaine Block Group
n=15 Participants
Injection of local anesthetic (mepivacaine) above and beside the femoral artery.
Mepivacaine: An ultrasound guided injection of mepivacaine superomedially to the femoral artery.
Perifemoral Injection of Local Anesthetic: An ultrasound guided injection of mepivacaine superomedially to the formal artery in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.
|
Saline Sham Group
n=15 Participants
Injection of salt water (saline) above and beside the femoral artery.
Perifemoral Injection of Local Anesthetic: An ultrasound guided injection of mepivacaine superomedially to the formal artery in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.
Saline: An ultrasound guided injection using a medication that does NOT numb any nerves called saline, or salt water.
|
|---|---|---|
|
Number of Subjects Experiencing Tourniquet Hypertension
|
5 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: While in PACU (~1 hour)Population: Subjects who completed the study.
The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. 0 = No Pain, 1-3 = Mild Pain, 4-6 = Moderate Pain, 7-10 = Severe Pain.
Outcome measures
| Measure |
Mepivacaine Block Group
n=15 Participants
Injection of local anesthetic (mepivacaine) above and beside the femoral artery.
Mepivacaine: An ultrasound guided injection of mepivacaine superomedially to the femoral artery.
Perifemoral Injection of Local Anesthetic: An ultrasound guided injection of mepivacaine superomedially to the formal artery in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.
|
Saline Sham Group
n=15 Participants
Injection of salt water (saline) above and beside the femoral artery.
Perifemoral Injection of Local Anesthetic: An ultrasound guided injection of mepivacaine superomedially to the formal artery in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.
Saline: An ultrasound guided injection using a medication that does NOT numb any nerves called saline, or salt water.
|
|---|---|---|
|
Pain Scores as Measured by the Numeric Rating Scale (NRS-11)
|
1.80 score on a scale
Standard Deviation 2.86
|
1.07 score on a scale
Standard Deviation 1.71
|
SECONDARY outcome
Timeframe: Perioperative period (~4 hours)Population: Subjects who completed the study.
Amount of opioid pain medication used by patient over a 4 hour period immediately after surgery. Opioids taken are converted to morphine equivalents.
Outcome measures
| Measure |
Mepivacaine Block Group
n=15 Participants
Injection of local anesthetic (mepivacaine) above and beside the femoral artery.
Mepivacaine: An ultrasound guided injection of mepivacaine superomedially to the femoral artery.
Perifemoral Injection of Local Anesthetic: An ultrasound guided injection of mepivacaine superomedially to the formal artery in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.
|
Saline Sham Group
n=15 Participants
Injection of salt water (saline) above and beside the femoral artery.
Perifemoral Injection of Local Anesthetic: An ultrasound guided injection of mepivacaine superomedially to the formal artery in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.
Saline: An ultrasound guided injection using a medication that does NOT numb any nerves called saline, or salt water.
|
|---|---|---|
|
Amount of Opioid Pain Medications Used by Patient
|
10.48 morphine equivalents
Standard Deviation 5.77
|
8.19 morphine equivalents
Standard Deviation 4.65
|
SECONDARY outcome
Timeframe: Intraoperatively (~3 hours)Population: Subjects who completed the study.
Amount of esmolol (in mg) used intraoperatively to decrease blood pressure after subject achieved tourniquet hypertension.
Outcome measures
| Measure |
Mepivacaine Block Group
n=15 Participants
Injection of local anesthetic (mepivacaine) above and beside the femoral artery.
Mepivacaine: An ultrasound guided injection of mepivacaine superomedially to the femoral artery.
Perifemoral Injection of Local Anesthetic: An ultrasound guided injection of mepivacaine superomedially to the formal artery in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.
|
Saline Sham Group
n=15 Participants
Injection of salt water (saline) above and beside the femoral artery.
Perifemoral Injection of Local Anesthetic: An ultrasound guided injection of mepivacaine superomedially to the formal artery in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.
Saline: An ultrasound guided injection using a medication that does NOT numb any nerves called saline, or salt water.
|
|---|---|---|
|
Amount of Esmolol Used Intraoperatively
|
8.00 mg
Standard Deviation 14.24
|
95.33 mg
Standard Deviation 107.63
|
Adverse Events
Mepivacaine Block Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Saline Sham 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
William Michael Bullock, MD, PhD
Duke University Medical Center
Phone: 919-681-6437
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place