Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ultrasound-Guided Landmark and Epidural Site Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02813681
Recruitment Status : Completed
First Posted : June 27, 2016
Results First Posted : October 3, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

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.

Condition or disease Intervention/treatment Phase
Back Pain Epidural Analgesia, Obstetric Procedure: US-epidural SVD Procedure: US sham- epidural SVD Procedure: Spontaneous vaginal delivery without an Epidural Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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 Start Date : May 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: US-epidural SVD
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
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.

Sham Comparator: (US sham- epidural SVD)
US sham- epidural SVD group- participants who received US examination process but with the monitor turned off.
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).

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




Primary Outcome Measures :
  1. Epidural Pressure Sensitivity at Level of Epidural Insertion [ 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. ]
    pressure sensitivity at level of epidural insertion will be measured with an algometer (Newtons)


Secondary Outcome Measures :
  1. Induction Medication [ Time Frame: The chart review will determine the use of induction medication immediately prior to the epidural placement ]
    The investigator will review the chart to see if the participant used of induction medication (answer yes will be recorded)

  2. Opioid Use During Labor [ Time Frame: A chart review of systemic opioids given to participant when the epidural is removed ]
    The investigator will review the chart to see if the participant required opioids during labor (yes will be recorded)

  3. Short-term Back Pain [ Time Frame: Participants will be asked if they have had back pain for longer than a week immediately prior to epidural placement ]
    The investigator will ask the participant if they have had back pain lasting longer than one week during pregnancy? (yes answer will be recorded)

  4. Number of Needle Repositions [ Time Frame: The number of needle reposition will be counted during epidural placement. ]
    The investigator will count the number epidural needle repositions during the epidural placement (whole number)

  5. Number of Needle Insertions [ Time Frame: The number of needle insertions will be counted during epidural placement. ]
    The investigator will count the number epidural needle insertions during the epidural placement (whole number)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813681


Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
Layout table for investigator information
Principal Investigator: Denise Wilkes UTMB
Layout table for additonal information
Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT02813681    
Other Study ID Numbers: 14-0110
First Posted: June 27, 2016    Key Record Dates
Results First Posted: October 3, 2019
Last Update Posted: October 3, 2019
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by The University of Texas Medical Branch, Galveston:
Acute Pain
ultrasonography
Additional relevant MeSH terms:
Layout table for MeSH terms
Back Pain
Pain
Neurologic Manifestations