Clinical trial

A Randomized Controlled Trial of Combined Spinal Epidural Versus Dural Puncture Epidural Techniques for Labor Analgesia

Name

Pro00108996

Description

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.

Trial arms

Trial start

2021-11-21

Estimated PCD

2023-12-07

Trial end

2023-12-07

Status

Completed

Phase

Early phase I

Treatment

Ropivacaine 0.1% Injectable Solution

DPE

Arms:

Combined Spinal Epidural, Dural Puncture Epidural

Other names:

Fentanyl

Bupivacaine 0.25% Injectable Solution

CSE

Arms:

Combined Spinal Epidural

Other names:

Ropivacaine 0.1% Injectable Solution, Fentanyl

Size

100

Primary endpoint

Block quality as defined by a composite of five components

From placement of epidural to delivery of baby, up to 32 hours

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}

Updated at

2024-02-29

1 organization

2 products

1 indication

Organization

Product

Indication

Product