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Comparison of Labor Analgesia Between Modified Combined Spinal-Epidural and Dural Puncture Epidural Techniques

NCT03258879 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-11-14

No results posted yet for this study

Summary

Epidural, Combined Spinal-Epidural, and more recently dural puncture epidural are forms of neuraxial anesthesia used to provide pain relief in laboring women . The investigators want to assess the onset of pain relief with 2 different neuraxial techniques performed at our center, but which have not yet been compared in the literature: (1) Modified CSE, with only local anesthetic injected into the spinal fluid to reduce side effects of opioids that are seen with the traditional CSE and (2) Dural Puncture Epidural (DPE), involving puncture of the spinal membrane, but without injection of medication into the spinal space. The investigators hypothesize that the onset of labor analgesia will be faster with modified CSE compared to DPE.

Conditions

  • To Determine the Onset of Analgesia (Numerical Rating Scale for Pain = 1) in Minutes

Interventions

PROCEDURE

Modified CSE

MCSE group: 1 ml of 0.25% bupivacaine will be injected intrathecally

PROCEDURE

Dural puncture epidural

DPE group: Dural puncture performed, but no medication will be injected intrathecally.

Sponsors & Collaborators

  • Western University, Canada

    lead OTHER

Principal Investigators

  • Indu Singh, MD, FRCPC · Western University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-31
Primary Completion
2018-08-31
Completion
2018-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03258879 on ClinicalTrials.gov