Trial Outcomes & Findings for Optimizing Dose of Bupivacaine in Combined Spinal Epidurals To Reduce Side Effects (NCT NCT02159807)
NCT ID: NCT02159807
Last Updated: 2019-01-03
Results Overview
Maternal diastolic blood pressure at 60 minutes after epidural to measure maternal hypotension
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
170 participants
Primary outcome timeframe
at 1 hour
Results posted on
2019-01-03
Participant Flow
Enrollment period from April 2015 and completed Dec 2017
Participant milestones
| Measure |
1.25 mg Bupivacaine
1.25mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal
|
1.66 mg Bupivacaine
1.66mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy. Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal
|
2.5 mg Bupivacaine
2.5mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy. Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal
|
|---|---|---|---|
|
Overall Study
STARTED
|
67
|
52
|
51
|
|
Overall Study
COMPLETED
|
66
|
51
|
48
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
3
|
Reasons for withdrawal
| Measure |
1.25 mg Bupivacaine
1.25mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal
|
1.66 mg Bupivacaine
1.66mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy. Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal
|
2.5 mg Bupivacaine
2.5mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy. Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
|
Overall Study
No CSF
|
1
|
1
|
1
|
|
Overall Study
elevated blood pressure
|
0
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
1.25 mg Bupivacaine
n=66 Participants
1.25mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal
|
1.66 mg Bupivacaine
n=51 Participants
1.66mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy. Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal
|
2.5 mg Bupivacaine
n=48 Participants
2.5mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy. Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal
|
Total
n=165 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=66 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=165 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
66 Participants
n=66 Participants
|
51 Participants
n=51 Participants
|
48 Participants
n=48 Participants
|
165 Participants
n=165 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=66 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=165 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=66 Participants
|
51 Participants
n=51 Participants
|
48 Participants
n=48 Participants
|
165 Participants
n=165 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=66 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=165 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Fetal Heart Rate (FHR)
|
141.13 beats per min
STANDARD_DEVIATION 12.34 • n=66 Participants
|
136.08 beats per min
STANDARD_DEVIATION 9.8 • n=51 Participants
|
135.23 beats per min
STANDARD_DEVIATION 9.57 • n=48 Participants
|
137.48 beats per min
STANDARD_DEVIATION 10.57 • n=165 Participants
|
|
Pain Score
|
8.15 units on a scale
STANDARD_DEVIATION 2.27 • n=66 Participants
|
8.24 units on a scale
STANDARD_DEVIATION 1.61 • n=51 Participants
|
8.61 units on a scale
STANDARD_DEVIATION 1.51 • n=48 Participants
|
8.33 units on a scale
STANDARD_DEVIATION 1.79 • n=165 Participants
|
PRIMARY outcome
Timeframe: at 1 hourMaternal diastolic blood pressure at 60 minutes after epidural to measure maternal hypotension
Outcome measures
| Measure |
1.25 mg Bupivacaine
n=66 Participants
1.25mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal
|
1.66 mg Bupivacaine
n=51 Participants
1.66mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy. Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal
|
2.5 mg Bupivacaine
n=48 Participants
2.5mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy. Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal
|
|---|---|---|---|
|
Maternal Blood Pressure
|
78.2 mm/Hg
Standard Deviation 8.17
|
79.58 mm/Hg
Standard Deviation 9.25
|
80.52 mm/Hg
Standard Deviation 8.51
|
SECONDARY outcome
Timeframe: at 1 hourBaby's heart rate recorded with the external monitor that is placed on patient's belly, for a duration of 60 minutes after the placement of the combined spinal epidural.
Outcome measures
| Measure |
1.25 mg Bupivacaine
n=66 Participants
1.25mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal
|
1.66 mg Bupivacaine
n=51 Participants
1.66mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy. Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal
|
2.5 mg Bupivacaine
n=48 Participants
2.5mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy. Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal
|
|---|---|---|---|
|
Fetal Heart Rate at 1 Hour
|
134.73 beats per minute
Standard Deviation 10.87
|
137.64 beats per minute
Standard Deviation 10.35
|
135.57 beats per minute
Standard Deviation 10.07
|
SECONDARY outcome
Timeframe: baseline and 60 minutesMean change of her pain relief from the spinal epidural 60 minutes after she received it, using a VAS, scored from 0 to 10, with higher score indicating more pain.
Outcome measures
| Measure |
1.25 mg Bupivacaine
n=66 Participants
1.25mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal
|
1.66 mg Bupivacaine
n=51 Participants
1.66mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy. Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal
|
2.5 mg Bupivacaine
n=48 Participants
2.5mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy. Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal
|
|---|---|---|---|
|
Mean Change in Visual Analog Scale for Pain
|
0.43 score on a scale
Standard Deviation 1.13
|
0.46 score on a scale
Standard Deviation 1.28
|
0.26 score on a scale
Standard Deviation 1.07
|
Adverse Events
1.25 mg Bupivacaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
1.66 mg Bupivacaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2.5 mg Bupivacaine
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1.25 mg Bupivacaine
n=66 participants at risk
1.25mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal
|
1.66 mg Bupivacaine
n=51 participants at risk
1.66mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy. Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal
|
2.5 mg Bupivacaine
n=48 participants at risk
2.5mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy. Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal
|
|---|---|---|---|
|
Vascular disorders
vasovagal response
|
0.00%
0/66 • 60 minutes
|
0.00%
0/51 • 60 minutes
|
2.1%
1/48 • 60 minutes
|
Additional Information
Dr. Barbara Orlando
Icahn School of Medicine at Mount Sinai
Phone: 917-496-7490
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place