Trial Outcomes & Findings for Peripheral Nerve Blocks for Major Lower Extremity Amputations (NCT NCT03174782)
NCT ID: NCT03174782
Last Updated: 2023-06-12
Results Overview
Postoperative pain will be assessed by McGill questionaire
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
42 participants
Primary outcome timeframe
6 months
Results posted on
2023-06-12
Participant Flow
All patients included were evaluated by the vascular surgery service and had lower extremity amputation deemed necessary based on ischemic disease, infectious disease, and/or disfiguration. Patients were selected from 2018-2020 at the following sites; Community Regional Medical Center, Clovis Community Medical Center, and Fresno Heart and Surgical Hospital.
Participant milestones
| Measure |
Treatment
Patients randomized to the treatment group will receive regional nerve blocks (sciatic and femoral) with bupivacaine at the dose of 1 mg/kg.
Bupivacaine: Patients randomized to the treatment group will receive regional nerve blocks (sciatic and femoral) with bupivacaine at the dose of 1 mg/kg.
|
Control
Patients randomized to the control group will receive two needle sticks (in the sciatic and femoral distributions) with normal saline to maintain the double-blinded investigation.
Saline Solution: Patients randomized to the control group will receive two needle sticks (in the sciatic and femoral distributions) with normal saline to maintain the double-blinded investigation.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
23
|
|
Overall Study
COMPLETED
|
18
|
22
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Treatment
Patients randomized to the treatment group will receive regional nerve blocks (sciatic and femoral) with bupivacaine at the dose of 1 mg/kg.
Bupivacaine: Patients randomized to the treatment group will receive regional nerve blocks (sciatic and femoral) with bupivacaine at the dose of 1 mg/kg.
|
Control
Patients randomized to the control group will receive two needle sticks (in the sciatic and femoral distributions) with normal saline to maintain the double-blinded investigation.
Saline Solution: Patients randomized to the control group will receive two needle sticks (in the sciatic and femoral distributions) with normal saline to maintain the double-blinded investigation.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Unable to perform procedure by medical staff
|
0
|
1
|
Baseline Characteristics
Peripheral Nerve Blocks for Major Lower Extremity Amputations
Baseline characteristics by cohort
| Measure |
Treatment
n=18 Participants
Patients randomized to the treatment group will receive regional nerve blocks (sciatic and femoral) with bupivacaine at the dose of 1 mg/kg.
Bupivacaine: Patients randomized to the treatment group will receive regional nerve blocks (sciatic and femoral) with bupivacaine at the dose of 1 mg/kg.
|
Control
n=22 Participants
Patients randomized to the control group will receive two needle sticks (in the sciatic and femoral distributions) with normal saline to maintain the double-blinded investigation.
Saline Solution: Patients randomized to the control group will receive two needle sticks (in the sciatic and femoral distributions) with normal saline to maintain the double-blinded investigation.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 14 • n=99 Participants
|
58 years
STANDARD_DEVIATION 12 • n=107 Participants
|
59 years
STANDARD_DEVIATION 13 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Hispanic
|
7 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
BMI
|
28 kg/m^2
STANDARD_DEVIATION 8 • n=99 Participants
|
29 kg/m^2
STANDARD_DEVIATION 6 • n=107 Participants
|
29 kg/m^2
STANDARD_DEVIATION 7 • n=206 Participants
|
|
Weight
|
80 kg
STANDARD_DEVIATION 26 • n=99 Participants
|
87 kg
STANDARD_DEVIATION 20 • n=107 Participants
|
84 kg
STANDARD_DEVIATION 23 • n=206 Participants
|
|
Reason
Ischemia
|
10 participants
n=99 Participants
|
7 participants
n=107 Participants
|
15 participants
n=206 Participants
|
|
Reason
Infection
|
2 participants
n=99 Participants
|
5 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Reason
Wound
|
2 participants
n=99 Participants
|
5 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Reason
Osteomyelitis/ Charcot
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Reason
Gangrene
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Reason
Other
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Co-morbidities
Hypertension (HTN)
|
15 participants
n=99 Participants
|
21 participants
n=107 Participants
|
36 participants
n=206 Participants
|
|
Co-morbidities
Hyperlipidemia (HLD)
|
6 participants
n=99 Participants
|
14 participants
n=107 Participants
|
20 participants
n=206 Participants
|
|
Co-morbidities
Diabetes Mellitus (DM)
|
11 participants
n=99 Participants
|
19 participants
n=107 Participants
|
30 participants
n=206 Participants
|
|
Co-morbidities
Congestive Heart Failure (CHF)
|
2 participants
n=99 Participants
|
7 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Co-morbidities
End Stage Renal Disease (ESRD)
|
5 participants
n=99 Participants
|
3 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Co-morbidities
Peripheral Artery/Venous Disease
|
4 participants
n=99 Participants
|
10 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
Co-morbidities
Coronary Artery Disease(CAD)
|
3 participants
n=99 Participants
|
6 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Co-morbidities
Smoker
|
13 participants
n=99 Participants
|
14 participants
n=107 Participants
|
27 participants
n=206 Participants
|
|
Laterality
Left
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Laterality
Right
|
9 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: No data were collected for this outcome measure since the study was terminated before collecting the outcome measure data.
Postoperative pain will be assessed by McGill questionaire
Outcome measures
Outcome data not reported
Adverse Events
Treatment
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment
n=18 participants at risk
Patients randomized to the treatment group will receive regional nerve blocks (sciatic and femoral) with bupivacaine at the dose of 1 mg/kg.
Bupivacaine: Patients randomized to the treatment group will receive regional nerve blocks (sciatic and femoral) with bupivacaine at the dose of 1 mg/kg.
|
Control
n=22 participants at risk
Patients randomized to the control group will receive two needle sticks (in the sciatic and femoral distributions) with normal saline to maintain the double-blinded investigation.
Saline Solution: Patients randomized to the control group will receive two needle sticks (in the sciatic and femoral distributions) with normal saline to maintain the double-blinded investigation.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Complication
|
33.3%
6/18 • 6 months
No data were collected for All-Cause Mortality and Other (Not Including Serious) Adverse Events since the study was terminated before collecting this adverse event data.
|
13.6%
3/22 • 6 months
No data were collected for All-Cause Mortality and Other (Not Including Serious) Adverse Events since the study was terminated before collecting this adverse event data.
|
Other adverse events
Adverse event data not reported
Additional Information
Kamell Eckroth-Bernard
University of California, San Francisco- Fresno
Phone: 559-431-6226
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place