Trial Outcomes & Findings for PIEB vs CEI for Labor Analgesia: An MLAC Study (NCT NCT02573597)
NCT ID: NCT02573597
Last Updated: 2022-10-18
Results Overview
The mean concentration of Bupivacaine in patients who have success or failure outcome were compared between groups.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
31 participants
Primary outcome timeframe
From initial epidural bolus to delivery (up to approximately 16 hours)
Results posted on
2022-10-18
Participant Flow
Patients who met the protocol-specified "reject" criteria were censored (had no subsequent outcome measure data collected and were not considered analyzable for outcome measures) and were considered to have completed the study. Upon reject, catheter management was at discretion of anesthesia care provider.
Participant milestones
| Measure |
Part A Group 1
CEI bupivacaine and CEI sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
Part A Group 2
PIEB bupivacaine and PIEB sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
Part B Group 3
CEI bupivacaine and PIEB sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
Part B Group 4
PIEB bupivacaine and CEI sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
6
|
9
|
8
|
|
Overall Study
Met Reject Critera
|
4
|
1
|
3
|
2
|
|
Overall Study
Analyzable Data Set
|
4
|
5
|
6
|
6
|
|
Overall Study
COMPLETED
|
8
|
6
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PIEB vs CEI for Labor Analgesia: An MLAC Study
Baseline characteristics by cohort
| Measure |
Part A Group 1
n=8 Participants
CEI bupivacaine and CEI sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
Part A Group 2
n=6 Participants
PIEB bupivacaine and PIEB sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
Part B Group 3
n=9 Participants
CEI bupivacaine and PIEB sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
Part B Group 4
n=8 Participants
PIEB bupivacaine and CEI sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
33.5 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
30 years
STANDARD_DEVIATION 5.7 • n=7 Participants
|
33.1 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
30.6 years
STANDARD_DEVIATION 6.8 • n=4 Participants
|
32.0 years
STANDARD_DEVIATION 6.4 • n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From initial epidural bolus to delivery (up to approximately 16 hours)Population: Analyzable data set (did not meet the protocol-specified "reject" criteria).
The mean concentration of Bupivacaine in patients who have success or failure outcome were compared between groups.
Outcome measures
| Measure |
Part A Group 1
n=4 Participants
CEI bupivacaine and CEI sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
Part A Group 2
n=5 Participants
PIEB bupivacaine and PIEB sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
Part B Group 3
n=6 Participants
CEI bupivacaine and PIEB sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
Part B Group 4
n=6 Participants
PIEB bupivacaine and CEI sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
|---|---|---|---|---|
|
Minimum Local Analgesic Concentration (MLAC) of the Final Participants in Each Respective Group at Study Completion
|
0.06 % mg/ml
Standard Deviation 0.008
|
0.06 % mg/ml
Standard Deviation 0.007
|
0.075 % mg/ml
Standard Deviation 0.010
|
0.072 % mg/ml
Standard Deviation 0.008
|
SECONDARY outcome
Timeframe: From initial epidural bolus to delivery (up to 16 hours following initial bolus)Population: Analyzable data set (did not meet the protocol-specified "reject" criteria).
The time to first clinician rescue analgesia request in patients who have success or failure outcome were compared between groups.
Outcome measures
| Measure |
Part A Group 1
n=4 Participants
CEI bupivacaine and CEI sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
Part A Group 2
n=5 Participants
PIEB bupivacaine and PIEB sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
Part B Group 3
n=6 Participants
CEI bupivacaine and PIEB sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
Part B Group 4
n=6 Participants
PIEB bupivacaine and CEI sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
|---|---|---|---|---|
|
Time to First Clinician Rescue Analgesia Request (From Initial Epidural Dose)
|
4.3 hours
Standard Deviation 1.7
|
5.3 hours
Standard Deviation 1.2
|
7.5 hours
Standard Deviation 5.2
|
4.8 hours
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Patients were assessed once between initial epidural bolus to delivery (up to 16 hours following initial bolus)Population: Analyzable data set (did not meet the protocol-specified "reject" criteria).
The initial pain score (VAS 0-10 scale with 0 means no pain and 10 means max pain) in patients who have success or failure outcome were compared between groups.
Outcome measures
| Measure |
Part A Group 1
n=4 Participants
CEI bupivacaine and CEI sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
Part A Group 2
n=5 Participants
PIEB bupivacaine and PIEB sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
Part B Group 3
n=6 Participants
CEI bupivacaine and PIEB sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
Part B Group 4
n=6 Participants
PIEB bupivacaine and CEI sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
|---|---|---|---|---|
|
Numerical Verbal Pain Scores
|
6.3 score on a scale
Standard Deviation 1.0
|
8.4 score on a scale
Standard Deviation 0.9
|
7.7 score on a scale
Standard Deviation 2.1
|
8.2 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Participants were assessed once from initial epidural bolus to delivery (up to approximately 16 hours)Population: Analyzable data set (did not meet the protocol-specified "reject" criteria).
0-100% (0 means least satisfaction and 100 means most satisfaction)
Outcome measures
| Measure |
Part A Group 1
n=4 Participants
CEI bupivacaine and CEI sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
Part A Group 2
n=5 Participants
PIEB bupivacaine and PIEB sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
Part B Group 3
n=6 Participants
CEI bupivacaine and PIEB sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
Part B Group 4
n=6 Participants
PIEB bupivacaine and CEI sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
|---|---|---|---|---|
|
Patient Satisfaction With Labor Analgesia
|
97.3 score on a scale
Standard Deviation 4.9
|
97.6 score on a scale
Standard Deviation 4.3
|
99.2 score on a scale
Standard Deviation 2.0
|
96.7 score on a scale
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: At the time of deliveryPopulation: Analyzable data set (did not meet the protocol-specified "reject" criteria).
Labor outcome in patients who have success or failure outcome were compared between groups.
Outcome measures
| Measure |
Part A Group 1
n=4 Participants
CEI bupivacaine and CEI sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
Part A Group 2
n=5 Participants
PIEB bupivacaine and PIEB sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
Part B Group 3
n=6 Participants
CEI bupivacaine and PIEB sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
Part B Group 4
n=6 Participants
PIEB bupivacaine and CEI sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
|---|---|---|---|---|
|
Labor Outcome (Spontaneous, Assisted, Cesarean)
Spontaneous
|
3 Participants
|
3 Participants
|
4 Participants
|
6 Participants
|
|
Labor Outcome (Spontaneous, Assisted, Cesarean)
C-section
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From initial epidural bolus to delivery (up to 16 hours following initial bolus)Population: Analyzable data set (did not meet the protocol-specified "reject" criteria).
Number of Participants Requiring Treatment for pruritus, nausea and vomiting, and hypotension were reported.
Outcome measures
| Measure |
Part A Group 1
n=4 Participants
CEI bupivacaine and CEI sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
Part A Group 2
n=5 Participants
PIEB bupivacaine and PIEB sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
Part B Group 3
n=6 Participants
CEI bupivacaine and PIEB sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
Part B Group 4
n=6 Participants
PIEB bupivacaine and CEI sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
|---|---|---|---|---|
|
Number of Participants Requiring Treatment for Pruritus, Nausea and Vomiting, or Hypotension
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From initial epidural bolus to delivery (up to 16 hours following initial bolus)Population: Analyzable data set (did not meet the protocol-specified "reject" criteria).
yes/no.
Outcome measures
| Measure |
Part A Group 1
n=4 Participants
CEI bupivacaine and CEI sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
Part A Group 2
n=5 Participants
PIEB bupivacaine and PIEB sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
Part B Group 3
n=6 Participants
CEI bupivacaine and PIEB sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
Part B Group 4
n=6 Participants
PIEB bupivacaine and CEI sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
|---|---|---|---|---|
|
Number of Participants With Maternal Nausea/Vomiting
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From initial epidural bolus to delivery (up to 16 hours following initial bolus)Population: Analyzable data set (did not meet the protocol-specified "reject" criteria).
Success - No supplemental analgesia request until vaginal exam c/w 8 cm dilation or more -\> 0.01% w/v reduction in subsequent participant's local anesthetic. Failure - Supplemental analgesia request c vaginal exam c/w less than 8 cm dilatation -\>0.01% w/v increase in subsequent LA infusion.
Outcome measures
| Measure |
Part A Group 1
n=4 Participants
CEI bupivacaine and CEI sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
Part A Group 2
n=5 Participants
PIEB bupivacaine and PIEB sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
Part B Group 3
n=6 Participants
CEI bupivacaine and PIEB sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
Part B Group 4
n=6 Participants
PIEB bupivacaine and CEI sufentanil
Bupivacaine: Continuous or bolus administration
Sufentanil: Continuous or bolus administration
|
|---|---|---|---|---|
|
Protocol Success or Failure
Success
|
1 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Protocol Success or Failure
Failure
|
3 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From initial epidural bolus to delivery (up to 16 hours following initial bolus)scale from from 0-10
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From initial epidural bolus to delivery (up to 16 hours following initial bolus)Straight leg lift, yes/no
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From initial epidural bolus to approximately 6-12 hours following deliveryOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From initial epidural bolus to delivery (up to 16 hours following initial bolus)Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From initial epidural bolus to delivery (up to 16 hours following initial bolus)yes/no
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From initial epidural bolus to delivery (up to 16 hours following initial bolus)Outcome measures
Outcome data not reported
Adverse Events
Part A Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A Group 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B Group 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B Group 4
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. Brendan Carvalho
Stanford University School of Medicine
Phone: (650) 861-8607
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place