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Impact of Dural Puncture Epidural Versus Traditional Lumbar Epidural on Onset of Labor Analgesia

Primary Purpose

Labor Pain, Labor Analgesia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Lumbar Epidural

Dural Puncture Epidural

About this trial

This is an interventional treatment trial for Labor Pain

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Pregnant patients in active painful labor
ASA I and II parturients
Women Ages 18+ to 40
Patients who have labor epidural as part of their labor plan will be recruited

Exclusion Criteria:

Patients admitted to the Labor and Delivery Suite who are committed to have a delivery with the current admission but who do not want a labor epidural
Patients with the following: bleeding disorders, infection at the site of epidural placement, generalized sepsis, stenotic heart valve lesions, increased intracranial pressure, patients with hypovolemia, and patient refusal
Parturients with chronic pain syndromes
Patients on MAO inhibitors
Patients with allergies to bupivacaine and fentanyl (and other amide local anesthetics) patients with substance abuse history will be excluded
Non English-speaking patients will be excluded

Sites / Locations

Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Lumbar Epidural

Dural Puncture Epidural

Arm Description

Control group will have standard of care Lumbar Epidural

Will receive Dural Puncture Epidural

Outcomes

Primary Outcome Measures

Compare time of onset of labor analgesia Dural Puncture vs Lumbar Puncture

Secondary Outcome Measures

Incidence of Side Effect

Incidence of maternal motor block, hypotension, pruritis, headache, patient satisfaction and fetal bradycardia.

Full Information

NCT ID

NCT02412969

First Posted

August 22, 2014

Last Updated

August 16, 2016

Sponsor

Medical University of South Carolina

1. Study Identification

Unique Protocol Identification Number

NCT02412969

Brief Title

Impact of Dural Puncture Epidural Versus Traditional Lumbar Epidural on Onset of Labor Analgesia

Official Title

Impact of Dural Puncture Epidural Versus Traditional Lumbar Epidural on Onset of Labor Analgesia

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

August 2014 (undefined)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of South Carolina

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is to examine the onset of pain relief with two different methods of labor epidural. The traditional labor epidural involves the placement of numbing and anti-pain medicine in the epidural space which surrounds the spinal cord. In order to take effect, the medication has to cross a layer of tissue called the dura. In the current study, the same medications are placed in the epidural space after the dura is punctured with a fine needle. This research, will help evaluate whether this technique will result in earlier onset of pain relief.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Labor Pain, Labor Analgesia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

101 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lumbar Epidural

Arm Type

Active Comparator

Arm Description

Control group will have standard of care Lumbar Epidural

Arm Title

Dural Puncture Epidural

Arm Type

Experimental

Arm Description

Will receive Dural Puncture Epidural

Intervention Type

Procedure

Intervention Name(s)

Lumbar Epidural

Intervention Description

control group will receive lumbar puncture epidural

Intervention Type

Procedure

Intervention Name(s)

Dural Puncture Epidural

Intervention Description

intervention group will receive a dural puncture epidural

Primary Outcome Measure Information:

Title

Compare time of onset of labor analgesia Dural Puncture vs Lumbar Puncture

Time Frame

two days post delivery

Secondary Outcome Measure Information:

Title

Incidence of Side Effect

Description

Incidence of maternal motor block, hypotension, pruritis, headache, patient satisfaction and fetal bradycardia.

Time Frame

two days post delivery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pregnant patients in active painful labor ASA I and II parturients Women Ages 18+ to 40 Patients who have labor epidural as part of their labor plan will be recruited Exclusion Criteria: Patients admitted to the Labor and Delivery Suite who are committed to have a delivery with the current admission but who do not want a labor epidural Patients with the following: bleeding disorders, infection at the site of epidural placement, generalized sepsis, stenotic heart valve lesions, increased intracranial pressure, patients with hypovolemia, and patient refusal Parturients with chronic pain syndromes Patients on MAO inhibitors Patients with allergies to bupivacaine and fentanyl (and other amide local anesthetics) patients with substance abuse history will be excluded Non English-speaking patients will be excluded

Facility Information:

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

12. IPD Sharing Statement

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Impact of Dural Puncture Epidural Versus Traditional Lumbar Epidural on Onset of Labor Analgesia

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