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Ultrasound-Guided Landmark and Epidural Site Pain

Primary Purpose

Back Pain, Epidural Analgesia, Obstetric

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
US-epidural SVD
US sham- epidural SVD
Spontaneous vaginal delivery without an Epidural
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Back Pain focused on measuring Acute Pain, ultrasonography

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • pregnant with term (37 - 41 weeks) singleton gestation
  • active labor
  • history of normal pregnancy
  • request an epidural
  • age between 18 - 35 years old
  • able to understand the protocol and provide voluntary, written, informed consent.

Exclusion Criteria:

  • history of spinal surgery
  • scoliosis
  • epidural or spinal placement within the last 5 days
  • neuropathic pain disorders
  • chronic opioid use
  • Texas Department of Criminal Justice patient
  • placental percreta
  • placental increta
  • placenta accreta
  • preeclampsia
  • eclampsia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Sham Comparator

    Placebo Comparator

    Arm Label

    US-epidural SVD

    (US sham- epidural SVD)

    SVD without an Epidural

    Arm Description

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

    US sham- epidural SVD group- participants who received US examination process but with the monitor turned off.

    Spontaneous vaginal delivery without an Epidural group The purpose of the control group is to serve as a baseline.

    Outcomes

    Primary Outcome Measures

    Epidural Pressure Sensitivity at Level of Epidural Insertion
    pressure sensitivity at level of epidural insertion will be measured with an algometer (Newtons)

    Secondary Outcome Measures

    Induction Medication
    The investigator will review the chart to see if the participant used of induction medication (answer yes will be recorded)
    Opioid Use During Labor
    The investigator will review the chart to see if the participant required opioids during labor (yes will be recorded)
    Short-term Back Pain
    The investigator will ask the participant if they have had back pain lasting longer than one week during pregnancy? (yes answer will be recorded)
    Number of Needle Repositions
    The investigator will count the number epidural needle repositions during the epidural placement (whole number)
    Number of Needle Insertions
    The investigator will count the number epidural needle insertions during the epidural placement (whole number)

    Full Information

    First Posted
    June 16, 2016
    Last Updated
    October 2, 2019
    Sponsor
    The University of Texas Medical Branch, Galveston
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02813681
    Brief Title
    Ultrasound-Guided Landmark and Epidural Site Pain
    Official Title
    A Prospective Randomized Clinical Trial to Study the Effect of Pre-Epidural Ultrasound Examination on Epidural Insertion Site Pressure Sensitivity in Parturient
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2014 (undefined)
    Primary Completion Date
    May 2016 (Actual)
    Study Completion Date
    May 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The University of Texas Medical Branch, Galveston

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    Detailed Description
    Few studies have examined how epidural placement changes localized sensation at the epidural insertion site. This study will be the first study to quantitatively measure sensation at the epidural insertion site. The investigator will assess localized pressure sensitivity with an algometer. An algometer is a hand-held device commonly used by neurologist to detect sensory deficits and measures the pressure sensitivity threshold in a 1-cm diameter circular area. Ultrasound (US) pre-procedural examination provides more accurate landmarks for the placement of epidural catheters. The investigator will determine if an US examination prior to epidural placement reduces localized pressure sensitivity. The investigator will also determine if there are correlations between the participants characteristics and/or comorbidities and increased pressure sensitivity at the insertion site.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Back Pain, Epidural Analgesia, Obstetric
    Keywords
    Acute Pain, ultrasonography

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    US-epidural SVD
    Arm Type
    Active Comparator
    Arm Description
    US-epidural SVD group - participants who received US examination prior to epidural placement. The purpose of this group is to determine if US derived landmarks reduce pressure sensitivity
    Arm Title
    (US sham- epidural SVD)
    Arm Type
    Sham Comparator
    Arm Description
    US sham- epidural SVD group- participants who received US examination process but with the monitor turned off.
    Arm Title
    SVD without an Epidural
    Arm Type
    Placebo Comparator
    Arm Description
    Spontaneous vaginal delivery without an Epidural group The purpose of the control group is to serve as a baseline.
    Intervention Type
    Procedure
    Intervention Name(s)
    US-epidural SVD
    Intervention Description
    participants who received US examination prior to epidural placement. The purpose of this group is to determine if US derived landmarks reduce pressure sensitivity.
    Intervention Type
    Procedure
    Intervention Name(s)
    US sham- epidural SVD
    Intervention Description
    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).
    Intervention Type
    Procedure
    Intervention Name(s)
    Spontaneous vaginal delivery without an Epidural
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Epidural Pressure Sensitivity at Level of Epidural Insertion
    Description
    pressure sensitivity at level of epidural insertion will be measured with an algometer (Newtons)
    Time Frame
    Epidural pressure sensitivity was monitored 10 minutes prior to epidural insertion and then for 10 minutes on each day after epidural removal for 3 days.
    Secondary Outcome Measure Information:
    Title
    Induction Medication
    Description
    The investigator will review the chart to see if the participant used of induction medication (answer yes will be recorded)
    Time Frame
    The chart review will determine the use of induction medication immediately prior to the epidural placement
    Title
    Opioid Use During Labor
    Description
    The investigator will review the chart to see if the participant required opioids during labor (yes will be recorded)
    Time Frame
    A chart review of systemic opioids given to participant when the epidural is removed
    Title
    Short-term Back Pain
    Description
    The investigator will ask the participant if they have had back pain lasting longer than one week during pregnancy? (yes answer will be recorded)
    Time Frame
    Participants will be asked if they have had back pain for longer than a week immediately prior to epidural placement
    Title
    Number of Needle Repositions
    Description
    The investigator will count the number epidural needle repositions during the epidural placement (whole number)
    Time Frame
    The number of needle reposition will be counted during epidural placement.
    Title
    Number of Needle Insertions
    Description
    The investigator will count the number epidural needle insertions during the epidural placement (whole number)
    Time Frame
    The number of needle insertions will be counted during epidural placement.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: pregnant with term (37 - 41 weeks) singleton gestation active labor history of normal pregnancy request an epidural age between 18 - 35 years old able to understand the protocol and provide voluntary, written, informed consent. Exclusion Criteria: history of spinal surgery scoliosis epidural or spinal placement within the last 5 days neuropathic pain disorders chronic opioid use Texas Department of Criminal Justice patient placental percreta placental increta placenta accreta preeclampsia eclampsia
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Denise Wilkes
    Organizational Affiliation
    UTMB
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Ultrasound-Guided Landmark and Epidural Site Pain

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