Trial Outcomes & Findings for Post-cesarean Analgesia With Epidural Morphine Following Epidural 2-chloroprocaine (NCT NCT04369950)
NCT ID: NCT04369950
Last Updated: 2022-05-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
44 participants
Primary outcome timeframe
24 hours after epidural morphine administration
Results posted on
2022-05-26
Participant Flow
Participant milestones
| Measure |
2 Percent Lidocaine With Epinephrine and Epidural Morphine
2% lidocaine with 1:200,000 epinephrine and epidural morphine: Epidurals will be dosed with 2% lidocaine with 1:200,000 epinephrine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
|
3 Percent 2-Chloroprocaine and Epidural Morphine
3% 2-chloroprocaine and epidural morphine: Epidurals will be dosed with 3% 2-chloroprocaine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. This is the critical component to bridge the latency period between the offset of 3% 2-chloroprocaine and the peak action of epidural morphine.Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
2 Percent Lidocaine With Epinephrine and Epidural Morphine
2% lidocaine with 1:200,000 epinephrine and epidural morphine: Epidurals will be dosed with 2% lidocaine with 1:200,000 epinephrine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
|
3 Percent 2-Chloroprocaine and Epidural Morphine
3% 2-chloroprocaine and epidural morphine: Epidurals will be dosed with 3% 2-chloroprocaine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. This is the critical component to bridge the latency period between the offset of 3% 2-chloroprocaine and the peak action of epidural morphine.Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
2
|
Baseline Characteristics
Post-cesarean Analgesia With Epidural Morphine Following Epidural 2-chloroprocaine
Baseline characteristics by cohort
| Measure |
2 Percent Lidocaine With Epinephrine and Epidural Morphine
n=20 Participants
2% lidocaine with 1:200,000 epinephrine and epidural morphine: Epidurals will be dosed with 2% lidocaine with 1:200,000 epinephrine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
|
3 Percent 2-Chloroprocaine and Epidural Morphine
n=20 Participants
3% 2-chloroprocaine and epidural morphine: Epidurals will be dosed with 3% 2-chloroprocaine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. This is the critical component to bridge the latency period between the offset of 3% 2-chloroprocaine and the peak action of epidural morphine.Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.6 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
29.8 years
STANDARD_DEVIATION 5.4 • n=7 Participants
|
28.7 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Height
|
159.5 centimeters
STANDARD_DEVIATION 6.9 • n=5 Participants
|
163 centimeters
STANDARD_DEVIATION 7.5 • n=7 Participants
|
161.25 centimeters
STANDARD_DEVIATION 7.20 • n=5 Participants
|
|
Weight
|
84.0 kilograms
STANDARD_DEVIATION 13.2 • n=5 Participants
|
87.1 kilograms
STANDARD_DEVIATION 14.8 • n=7 Participants
|
85.55 kilograms
STANDARD_DEVIATION 14.02 • n=5 Participants
|
|
Body Mass Index
|
32.3 kg/m^2
STANDARD_DEVIATION 4.4 • n=5 Participants
|
32.4 kg/m^2
STANDARD_DEVIATION 4.2 • n=7 Participants
|
32.35 kg/m^2
STANDARD_DEVIATION 4.30 • n=5 Participants
|
|
Number of Participants who Smoke
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Gestational age
|
38.7 weeks
STANDARD_DEVIATION 1.1 • n=5 Participants
|
38.6 weeks
STANDARD_DEVIATION 1.1 • n=7 Participants
|
38.65 weeks
STANDARD_DEVIATION 1.1 • n=5 Participants
|
|
Gravida
|
1 pregnancies
n=5 Participants
|
2 pregnancies
n=7 Participants
|
1 pregnancies
n=5 Participants
|
|
Para
|
0 completed pregnancies
n=5 Participants
|
0 completed pregnancies
n=7 Participants
|
0 completed pregnancies
n=5 Participants
|
|
Duration of labor analgesia
|
8.5 hours
STANDARD_DEVIATION 4.8 • n=5 Participants
|
7.9 hours
STANDARD_DEVIATION 5.6 • n=7 Participants
|
8.2 hours
STANDARD_DEVIATION 5.21 • n=5 Participants
|
|
Surgical duration
|
34.5 minutes
n=5 Participants
|
42 minutes
n=7 Participants
|
38.5 minutes
n=5 Participants
|
|
Number of participants who received a labor analgesia with combined spinal epidural
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Number of Participants with Prior Cesarean Delivery / trial of labor after cesarean
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Surgical Complication (uterine artery laceration and postpartum hemorrhage)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours after epidural morphine administrationOutcome measures
| Measure |
2 Percent Lidocaine With Epinephrine and Epidural Morphine
n=20 Participants
2% lidocaine with 1:200,000 epinephrine and epidural morphine: Epidurals will be dosed with 2% lidocaine with 1:200,000 epinephrine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
|
3 Percent 2-Chloroprocaine and Epidural Morphine
n=20 Participants
3% 2-chloroprocaine and epidural morphine: Epidurals will be dosed with 3% 2-chloroprocaine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. This is the critical component to bridge the latency period between the offset of 3% 2-chloroprocaine and the peak action of epidural morphine.Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
|
|---|---|---|
|
Total Amount of Opioid Used
|
15 milligrams
Interval 6.3 to 22.5
|
0 milligrams
Interval 0.0 to 15.6
|
SECONDARY outcome
Timeframe: 12 hours after epidural morphine administrationOutcome measures
| Measure |
2 Percent Lidocaine With Epinephrine and Epidural Morphine
n=20 Participants
2% lidocaine with 1:200,000 epinephrine and epidural morphine: Epidurals will be dosed with 2% lidocaine with 1:200,000 epinephrine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
|
3 Percent 2-Chloroprocaine and Epidural Morphine
n=20 Participants
3% 2-chloroprocaine and epidural morphine: Epidurals will be dosed with 3% 2-chloroprocaine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. This is the critical component to bridge the latency period between the offset of 3% 2-chloroprocaine and the peak action of epidural morphine.Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
|
|---|---|---|
|
Total Amount of Opioid Used
|
0 hours
Interval 0.0 to 7.5
|
0 hours
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: 8 hours after epidural morphine administrationOutcome measures
| Measure |
2 Percent Lidocaine With Epinephrine and Epidural Morphine
n=20 Participants
2% lidocaine with 1:200,000 epinephrine and epidural morphine: Epidurals will be dosed with 2% lidocaine with 1:200,000 epinephrine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
|
3 Percent 2-Chloroprocaine and Epidural Morphine
n=20 Participants
3% 2-chloroprocaine and epidural morphine: Epidurals will be dosed with 3% 2-chloroprocaine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. This is the critical component to bridge the latency period between the offset of 3% 2-chloroprocaine and the peak action of epidural morphine.Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
|
|---|---|---|
|
Total Amount of Opioid Used
|
0 hours
Interval 0.0 to 7.5
|
0 hours
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: 4 hours after epidural morphine administrationOutcome measures
| Measure |
2 Percent Lidocaine With Epinephrine and Epidural Morphine
n=20 Participants
2% lidocaine with 1:200,000 epinephrine and epidural morphine: Epidurals will be dosed with 2% lidocaine with 1:200,000 epinephrine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
|
3 Percent 2-Chloroprocaine and Epidural Morphine
n=20 Participants
3% 2-chloroprocaine and epidural morphine: Epidurals will be dosed with 3% 2-chloroprocaine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. This is the critical component to bridge the latency period between the offset of 3% 2-chloroprocaine and the peak action of epidural morphine.Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
|
|---|---|---|
|
Total Amount of Opioid Used
|
0 hours
Interval 0.0 to 0.0
|
0 hours
Interval 0.0 to 8.1
|
SECONDARY outcome
Timeframe: 4,8, 12 and 24 hours after epidural morphine administrationscale ranges form 0-10, higher number indicating more pain
Outcome measures
| Measure |
2 Percent Lidocaine With Epinephrine and Epidural Morphine
n=20 Participants
2% lidocaine with 1:200,000 epinephrine and epidural morphine: Epidurals will be dosed with 2% lidocaine with 1:200,000 epinephrine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
|
3 Percent 2-Chloroprocaine and Epidural Morphine
n=20 Participants
3% 2-chloroprocaine and epidural morphine: Epidurals will be dosed with 3% 2-chloroprocaine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. This is the critical component to bridge the latency period between the offset of 3% 2-chloroprocaine and the peak action of epidural morphine.Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
|
|---|---|---|
|
Pain as Measured by a 11 Point Verbal Scale
4 hours
|
0 score on a scale
Interval 0.0 to 1.0
|
2.5 score on a scale
Interval 0.0 to 5.0
|
|
Pain as Measured by a 11 Point Verbal Scale
8 hours
|
0 score on a scale
Interval 0.0 to 4.5
|
1 score on a scale
Interval 0.0 to 4.0
|
|
Pain as Measured by a 11 Point Verbal Scale
12 hours
|
3 score on a scale
Interval 0.0 to 5.0
|
2 score on a scale
Interval 0.0 to 3.0
|
|
Pain as Measured by a 11 Point Verbal Scale
24 hours
|
7 score on a scale
Interval 4.0 to 7.5
|
3.5 score on a scale
Interval 1.0 to 6.0
|
SECONDARY outcome
Timeframe: 4,8, 12 and 24 hours after epidural morphine administrationscale ranges from non,mild and moderate-severe
Outcome measures
| Measure |
2 Percent Lidocaine With Epinephrine and Epidural Morphine
n=20 Participants
2% lidocaine with 1:200,000 epinephrine and epidural morphine: Epidurals will be dosed with 2% lidocaine with 1:200,000 epinephrine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
|
3 Percent 2-Chloroprocaine and Epidural Morphine
n=20 Participants
3% 2-chloroprocaine and epidural morphine: Epidurals will be dosed with 3% 2-chloroprocaine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. This is the critical component to bridge the latency period between the offset of 3% 2-chloroprocaine and the peak action of epidural morphine.Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
|
|---|---|---|
|
Number of Participants Who Had Mild, Moderate or Severe Nausea as Measured by a 3 Point Scale
4 hours
|
3 Participants
|
1 Participants
|
|
Number of Participants Who Had Mild, Moderate or Severe Nausea as Measured by a 3 Point Scale
8 hours
|
1 Participants
|
2 Participants
|
|
Number of Participants Who Had Mild, Moderate or Severe Nausea as Measured by a 3 Point Scale
12 hours
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Had Mild, Moderate or Severe Nausea as Measured by a 3 Point Scale
24 hours
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4,8, 12 and 24 hours after epidural morphine administrationscale ranges from non,mild and moderate-severe
Outcome measures
| Measure |
2 Percent Lidocaine With Epinephrine and Epidural Morphine
n=20 Participants
2% lidocaine with 1:200,000 epinephrine and epidural morphine: Epidurals will be dosed with 2% lidocaine with 1:200,000 epinephrine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
|
3 Percent 2-Chloroprocaine and Epidural Morphine
n=20 Participants
3% 2-chloroprocaine and epidural morphine: Epidurals will be dosed with 3% 2-chloroprocaine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. This is the critical component to bridge the latency period between the offset of 3% 2-chloroprocaine and the peak action of epidural morphine.Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
|
|---|---|---|
|
Number of Participants Who Had Mild, Moderate or Severe Pruritis as Measured by a 3 Point Scale
4 hours
|
7 Participants
|
3 Participants
|
|
Number of Participants Who Had Mild, Moderate or Severe Pruritis as Measured by a 3 Point Scale
8 hours
|
6 Participants
|
4 Participants
|
|
Number of Participants Who Had Mild, Moderate or Severe Pruritis as Measured by a 3 Point Scale
12 hours
|
4 Participants
|
3 Participants
|
|
Number of Participants Who Had Mild, Moderate or Severe Pruritis as Measured by a 3 Point Scale
24 hours
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 48 hours after epidural morphine administrationOutcome measures
| Measure |
2 Percent Lidocaine With Epinephrine and Epidural Morphine
n=20 Participants
2% lidocaine with 1:200,000 epinephrine and epidural morphine: Epidurals will be dosed with 2% lidocaine with 1:200,000 epinephrine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
|
3 Percent 2-Chloroprocaine and Epidural Morphine
n=20 Participants
3% 2-chloroprocaine and epidural morphine: Epidurals will be dosed with 3% 2-chloroprocaine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. This is the critical component to bridge the latency period between the offset of 3% 2-chloroprocaine and the peak action of epidural morphine.Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
|
|---|---|---|
|
Time Until First Opioid Request
|
14.8 hours
Interval 7.9 to 22.7
|
24.7 hours
Interval 2.7 to 36.6
|
Adverse Events
2 Percent Lidocaine With Epinephrine and Epidural Morphine
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
3 Percent 2-Chloroprocaine and Epidural Morphine
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
2 Percent Lidocaine With Epinephrine and Epidural Morphine
n=20 participants at risk
2% lidocaine with 1:200,000 epinephrine and epidural morphine: Epidurals will be dosed with 2% lidocaine with 1:200,000 epinephrine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
|
3 Percent 2-Chloroprocaine and Epidural Morphine
n=20 participants at risk
3% 2-chloroprocaine and epidural morphine: Epidurals will be dosed with 3% 2-chloroprocaine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. This is the critical component to bridge the latency period between the offset of 3% 2-chloroprocaine and the peak action of epidural morphine.Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
|
|---|---|---|
|
General disorders
Nausea
|
25.0%
5/20 • 24 hours
|
15.0%
3/20 • 24 hours
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
40.0%
8/20 • 24 hours
|
25.0%
5/20 • 24 hours
|
Additional Information
Linden Lee, MD, Assistant Professor
The University of Texas Health Science Center at Houston
Phone: (713) 500-6200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place