Trial Outcomes & Findings for Optimal Bupivacaine Dose for Initiation of Labor Epidural Techniques (NCT NCT04814537)
NCT ID: NCT04814537
Last Updated: 2026-08-04
Results Overview
The dose of bupivacaine with which 90% of participants achieve adequate analgesia (NRS\<3 at 30min)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
30 minutes
Results posted on
2026-08-04
Participant Flow
Participant milestones
| Measure |
Dural Puncture Epidural Technique
Laboring women receiving the Dural Puncture Epidural (DPE) Technique with dose of Bupivacaine 0.25% diluted to 20 mL with isotonic sterile 0.9% saline. The first subject in the DPE group will receive an initial dose of bupivacaine 25 mg, with an endpoint being the achievement of an NRS \< 3 at 30 min. Subsequent patients are administered bupivacaine doses determined by the response of the previous subject, as per the biased coin method. The subsequent up and down interval doses are bupivacaine 2.5 mg (1 mL) increments, with an anticipated dose range from 20 mg to 40 mg.
Bupivacaine Hydrochloride: Local Anesthetic Agent
|
Epidural Technique
Laboring women receiving the Conventional Epidural Technique (EPL) with dose of Bupivacaine 0.25% diluted to 20 mL with isotonic sterile 0.9% saline. The first subject in the EPL group will receive an initial dose of bupivacaine 25 mg, with an endpoint being the achievement of an NRS \< 3 at 30 min. Subsequent patients are administered bupivacaine doses determined by the response of the previous subject, as per the biased coin method. The subsequent up and down interval doses are bupivacaine 2.5 mg (1 mL) increments, with an anticipated dose range from 20 mg to 40 mg.
Bupivacaine Hydrochloride: Local Anesthetic Agent
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
45
|
50
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
5 participants were removed from analysis due to technical failure.
Baseline characteristics by cohort
| Measure |
Dural Puncture Epidural
n=50 Participants
Participants were randomized 1:1 to the DPE or EPL techniques based on a computer-generated (SAS Institute) schedule consisting of permuted blocks of random sizes 4, 6, or 8. The sequence was generated by a statistician with no clinical involvement in the trial. Upon request for labor analgesia, an attending or fellow anesthesiologist opened a sealed envelope containing the randomized DPE or EPL technique assignment with a specific dose allocation (dosing protocol and dose allocation).
|
Epidural
n=50 Participants
Participants were randomized 1:1 to the DPE or EPL techniques based on a computer-generated (SAS Institute) schedule consisting of permuted blocks of random sizes 4, 6, or 8. The sequence was generated by a statistician with no clinical involvement in the trial. Upon request for labor analgesia, an attending or fellow anesthesiologist opened a sealed envelope containing the randomized DPE or EPL technique assignment with a specific dose allocation (dosing protocol and dose allocation).
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=100 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=50 Participants
|
50 Participants
n=50 Participants
|
100 Participants
n=100 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=100 Participants
|
|
Age, Continuous
|
32.8 years
STANDARD_DEVIATION 3.5 • n=50 Participants
|
33.4 years
STANDARD_DEVIATION 3.4 • n=50 Participants
|
33.1 years
STANDARD_DEVIATION 3.45 • n=100 Participants
|
|
Sex/Gender, Customized
Female
|
50 Participants
n=50 Participants
|
50 Participants
n=50 Participants
|
100 Participants
n=100 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=45 Participants • 5 participants were removed from analysis due to technical failure.
|
0 Participants
n=50 Participants • 5 participants were removed from analysis due to technical failure.
|
0 Participants
n=95 Participants • 5 participants were removed from analysis due to technical failure.
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=45 Participants • 5 participants were removed from analysis due to technical failure.
|
2 Participants
n=50 Participants • 5 participants were removed from analysis due to technical failure.
|
7 Participants
n=95 Participants • 5 participants were removed from analysis due to technical failure.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=45 Participants • 5 participants were removed from analysis due to technical failure.
|
0 Participants
n=50 Participants • 5 participants were removed from analysis due to technical failure.
|
0 Participants
n=95 Participants • 5 participants were removed from analysis due to technical failure.
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=45 Participants • 5 participants were removed from analysis due to technical failure.
|
4 Participants
n=50 Participants • 5 participants were removed from analysis due to technical failure.
|
4 Participants
n=95 Participants • 5 participants were removed from analysis due to technical failure.
|
|
Race (NIH/OMB)
White
|
35 Participants
n=45 Participants • 5 participants were removed from analysis due to technical failure.
|
44 Participants
n=50 Participants • 5 participants were removed from analysis due to technical failure.
|
79 Participants
n=95 Participants • 5 participants were removed from analysis due to technical failure.
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=45 Participants • 5 participants were removed from analysis due to technical failure.
|
0 Participants
n=50 Participants • 5 participants were removed from analysis due to technical failure.
|
5 Participants
n=95 Participants • 5 participants were removed from analysis due to technical failure.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=45 Participants • 5 participants were removed from analysis due to technical failure.
|
0 Participants
n=50 Participants • 5 participants were removed from analysis due to technical failure.
|
0 Participants
n=95 Participants • 5 participants were removed from analysis due to technical failure.
|
|
Region of Enrollment
United States
|
50 participants
n=50 Participants
|
50 participants
n=50 Participants
|
100 participants
n=100 Participants
|
PRIMARY outcome
Timeframe: 30 minutesThe dose of bupivacaine with which 90% of participants achieve adequate analgesia (NRS\<3 at 30min)
Outcome measures
| Measure |
Dural Puncture Epidural Technique
n=45 Participants
Participants were randomized 1:1 to the DPE or EPL techniques based on a computer-generated (SAS Institute) schedule consisting of permuted blocks of random sizes 4, 6, or 8. The sequence was generated by a statistician with no clinical involvement in the trial. Upon request for EPL labor analgesia, an attending or fellow anesthesiologist opened a sealed envelope containing the randomized DPE or EPL technique assignment with a specific dose allocation (dosing protocol and dose allocation).
|
Epidural Technique
n=50 Participants
Participants were randomized 1:1 to the DPE or EPL techniques based on a computer-generated (SAS Institute) schedule consisting of permuted blocks of random sizes 4, 6, or 8. The sequence was generated by a statistician with no clinical involvement in the trial. Upon request for EPL labor analgesia, an attending or fellow anesthesiologist opened a sealed envelope containing the randomized DPE or EPL technique assignment with a specific dose allocation (dosing protocol and dose allocation).
|
|---|---|---|
|
ED90
|
29.30 mg
|
45.25 mg
|
Adverse Events
Dural Puncture Epidural Technique
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Epidural Technique
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place