Clinical trial NCT02813681: 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
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Epidural Analgesia, Obstetric
Keywords: Acute Pain
ultrasonography
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2016-06-27
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Epidural Pressure Sensitivity at Level of Epidural Insertion
timeFrame: 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 outcomes:
measure: Induction Medication
timeFrame: The chart review will determine the use of induction medication immediately prior to the epidural placement
measure: Opioid Use During Labor
timeFrame: A chart review of systemic opioids given to participant when the epidural is removed
measure: Short-term Back Pain
timeFrame: Participants will be asked if they have had back pain for longer than a week immediately prior to epidural placement
measure: Number of Needle Repositions
timeFrame: The number of needle reposition will be counted during epidural placement.
measure: Number of Needle Insertions
timeFrame: The number of needle insertions will be counted during epidural placement.
Other outcomes:
Locations:
Study officials:
affiliation: UTMB
name: Denise Wilkes
role: PRINCIPAL_INVESTIGATOR
References: