NCT01182220

Brief Summary

  1. 1.labor epidural quite often require bolus supplementation for better pain control control. Quite often this is due to sparing of sacral nerves.
  2. 2.If epidural is placed low in the L5/S1 interspace using ultrasound, this may minimize bolus requirement and improve patient labor experience.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 16, 2010

Completed
2.4 years until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

2.4 years

First QC Date

May 10, 2010

Last Update Submit

October 31, 2016

Conditions

Labor Pain

Keywords

epidurallabor painultrasound

Outcome Measures

Primary Outcomes (1)

  • 1.Blocking of S1 and S2 dermatomes

    After test dose and loading up of catheter, s1 and s2 dermatome blockage will be tested in L5/S1 epidural group vs conventionally placed epidural group. Idea is see if higher incidence of S1 and S2 blockage can be demonstrated in low epidural group.

    30 minutes after loading epidural

Secondary Outcomes (2)

  • Number of top up doses for pain control throughout labor

    from insertion till delivery average 8-24 hrs

  • Patient satisfaction

    Evaluated on Post deliver day 1

Study Arms (2)

Ultrasound L5/S1 catheter placement

Pt will have back scanned with Ultrasound and L5/S1 interspace localized for epidural placement.

Control Group

Patients will have catheter placed after clinically evaluating the back as is done routinely resulting in mid lumbar catheter placement in general.

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

active laboring patient without any complication requesting epdiural for pain control

You may qualify if:

  • Active labor age 18 or older

You may not qualify if:

  • Known contraindications to epidural analgesia
  • Any neurologic illness
  • Fetal abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Hospitals

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • TARIQ MALIK, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

  • Mohammed Minhaj, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2010

First Posted

August 16, 2010

Study Start

January 1, 2013

Primary Completion

June 1, 2015

Study Completion

July 1, 2015

Last Updated

November 1, 2016

Record last verified: 2016-10

Locations

US(1)