N/A
N=80
Ultrasound-Guided Landmark and Epidural Site Pain
Back Pain · Epidural Analgesia, Obstetric
Bottom Line
View on ClinicalTrials.gov: NCT02813681 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Epidural Pressure Sensitivity at Level of Epidural Insertion — 26.8; 26.8; 47.6 force (newtons/cm^2)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- US-epidural SVD (Procedure); US sham- epidural SVD (Procedure); Spontaneous vaginal delivery without an Epidural (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The University of Texas Medical Branch, Galveston
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Epidural Pressure Sensitivity at Level of Epidural Insertion |
26.8; 26.8; 47.6 | — |
| SECONDARY Induction Medication |
22; 28; 17 | — |
| SECONDARY Opioid Use During Labor |
6; 9; 9 | — |
| SECONDARY Short-term Back Pain |
4; 7; 7 | — |
| SECONDARY Number of Needle Repositions |
0.8; 2.2 | — |
| SECONDARY Number of Needle Insertions |
0.1; .8 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02813681). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.