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Ultrasound-Guided Landmark and Epidural Site Pain

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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

Tracking Information
First Submitted Date  ICMJE June 16, 2016
First Posted Date  ICMJE June 27, 2016
Results First Submitted Date  ICMJE September 7, 2018
Results First Posted Date  ICMJE October 3, 2019
Last Update Posted Date October 3, 2019
Study Start Date  ICMJE May 2014
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2019)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: June 22, 2016)
epidural insertion site pain [ Time Frame: 1-3 days ]
pressure sensitivity at level of epidural insertion, level above, and level below will be measured with an algometer (Newtons)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2019)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2016)
  • number of pregnancies [ Time Frame: 1-3 days ]
    chart will be reviewed to determine the number of pregnancies (whole number)
  • number of deliveries [ Time Frame: 1-3 days ]
    chart will be reviewed to determine the number of deliveries of live newborn (whole number)
  • length of labor [ Time Frame: 1-3 days ]
    time from admission to delivery of newborn will be measured (hours)
  • body mass index (BMI) [ Time Frame: 1-3 days ]
    BMI calculated by weight (kg) divided by height squared (m) = BMI (kg/m^2)
  • age [ Time Frame: 1-3 days ]
    we will determine age on the day of admission (years)
  • pain score [ Time Frame: 1-3 days ]
    we will use the numerical scale for pain to determine pain level (0-10 scale)
  • history of spinal [ Time Frame: 1-3 days ]
    total number of spinals with previous pregnancies, (whole number)
  • Induction Medication [ Time Frame: 1-3 days ]
    We will review the chart to see if the participant used of induction medication (answer yes or no will be recorded)
  • Opioid Use During Labor [ Time Frame: 1-3 days ]
    We will review the chart to see if the participant required opioids during labor (yeas or no will be recorded)
  • Short-term Back Pain [ Time Frame: 1-3 days ]
    We will ask the participant if they have had back pain lasting longer than one week during pregnancy? (yes or no answer will be recorded)
  • long-term back pain [ Time Frame: 1-3 days ]
    We will ask the participant if they have had back pain for more than 3 months prior this pregnancy? (yes or no answer will be recorded)
  • history of pain medication [ Time Frame: 1-3 days ]
    We will ask the participant if they have you taken pain medications for pain for more than 3 months? (answer yes or no will be recorded)
  • delivery type [ Time Frame: 1-3 days ]
    delivery type (categorical; vaginal, cesarean section)
  • number of contacts with bone [ Time Frame: 1 day ]
    we will count the number of contacts the epidural needle makes with bone during the epidural placement (whole number)
  • Number of Needle Repositions [ Time Frame: 1 day ]
    we will count the number epidural needle repositions during the epidural placement (whole number)
  • Number of Needle Insertions [ Time Frame: 1 day ]
    we will count the number epidural needle insertions during the epidural placement (whole number)
  • failure to thread catheter [ Time Frame: 1 day ]
    we will count the number of times the catheter is unable to thread into the epidural space during the epidural placement (whole number)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ultrasound-Guided Landmark and Epidural Site Pain
Official Title  ICMJE A Prospective Randomized Clinical Trial to Study the Effect of Pre-Epidural Ultrasound Examination on Epidural Insertion Site Pressure Sensitivity in Parturient
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Back Pain
  • Epidural Analgesia, Obstetric
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Procedure: US-epidural SVD
  • Sham Comparator: (US sham- epidural SVD)
    US sham- epidural SVD group- participants who received US examination process but with the monitor turned off.
    Intervention: Procedure: US sham- epidural SVD
  • 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.
    Intervention: Procedure: Spontaneous vaginal delivery without an Epidural
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 22, 2016)
80
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02813681
Other Study ID Numbers  ICMJE 14-0110
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party The University of Texas Medical Branch, Galveston
Study Sponsor  ICMJE The University of Texas Medical Branch, Galveston
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Denise Wilkes UTMB
PRS Account The University of Texas Medical Branch, Galveston
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP