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Phase 4 Completed N=101 Randomized Quadruple-blind Treatment

Comparing Effectiveness of CSE Versus DPE for Labor Analgesia

Source: ClinicalTrials.gov NCT05068661 ↗
Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcomePrimary: Number of Participants With the Presence of Any of the Five Block Quality Components (or More Than One) — 16; 13 Participants — p=0.486
◆ Published Evidence
No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

The primary purpose of this study is to determine if there are differences in block quality between the CSE and DPE techniques for labor analgesia in parturients in active labor. We hypothesize that when compared to the CSE technique, the DPE technique will significantly improve block quality in this population and require fewer "top-ups" and catheter replacements.

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With the Presence of Any of the Five Block Quality Components (or More Than One)
16; 13 0.486
SECONDARY
Maternal Adverse Events
40; 37 0.148
SECONDARY
Number of Participants With Motor Block as Measured by the Modified Bromage Score
13; 10 >0.999
SECONDARY
Duration of the Second Stage of Labor
23; 47 0.128
SECONDARY
Total Labor Epidural Time
443; 534 >0.999
SECONDARY
Total Anesthetic Dose Required
108; 108 >0.999
SECONDARY
Number of Participants Who Self-administered PCEA (Patient-controlled Epidural Analgesia) Boluses
40; 41 >0.999
SECONDARY
Mode of Delivery
32; 33; 2; 1; 1; 0 >0.999
SECONDARY
Postpartum: Satisfaction With Analgesia Overall
10; 10 >0.999

Eligibility Criteria

Inclusion Criteria

  • Ages 18-45, singleton, vertex fetuses at 37-41 weeks' gestation, nulliparous and multiparous women, cervical dilation of 2-7cm, pain score > 4, and English-speaking ability

Exclusion Criteria

  • Women with major cardiac disease, chronic pain, chronic opioid use
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05068661). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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