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Ultrasound-Guided Landmark and Epidural Site Pain

NCT02813681 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2019-10-03

Study results available
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Summary

Historically, women who have chronic back pain after pregnancy have attributed the cause to the epidural procedure. While many studies have shown no greater incidence of generalized post-partum back pain in those who received an epidural, no studies have measured localized pressure sensitivity at the epidural insertion site. Short-term pressure sensitivity might limit patient's mobility and activities in the post-partum period. Understanding the factors that increase insertion site pressure sensitivity will allow the investigators to modify epidural placement technique in order to minimize this effect.

Conditions

Interventions

PROCEDURE

US-epidural SVD

participants who received US examination prior to epidural placement. The purpose of this group is to determine if US derived landmarks reduce pressure sensitivity.

PROCEDURE

US sham- epidural SVD

participants who received US examination process but with the monitor turned off. The purpose of this group is to determine if the standard of care epidural placement technique will increase pressure sensitivity at the insertion site. The purpose of this group will also be to reduce the placebo effect from the US exam and to maintain blinding of the patient to their group status (US epidural or US sham epidural).

PROCEDURE

Spontaneous vaginal delivery without an Epidural

Spontaneous vaginal delivery without an Epidural The purpose of the control group is to serve as a baseline (or a measure of normal). The control participant's measurement will be compared to those that did receive treatments (either epidural alone or ultrasound and epidural). This information will tell the investigator how many women have back pain after spontaneous vaginal delivery. Participant must meet the inclusion requirements and not meet any of the exclusion requirements

Sponsors & Collaborators

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Principal Investigators

  • Denise Wilkes · UTMB

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2016-05-31
Completion
2016-05-31

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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 NCT02813681 on ClinicalTrials.gov