Ultrasound-Guided Landmark and Epidural Site Pain

Back Pain Clinical Trial

Official title:

A Prospective Randomized Clinical Trial to Study the Effect of Pre-Epidural Ultrasound Examination on Epidural Insertion Site Pressure Sensitivity in Parturient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02813681
• Other study ID #: 14-0110
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Epidural Analgesia, Obstetric

Intervention

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.
• 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).
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epidural Pressure Sensitivity at Level of Epidural Insertion	pressure sensitivity at level of epidural insertion will be measured with an algometer (Newtons)	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	Induction Medication	The investigator will review the chart to see if the participant used of induction medication (answer yes will be recorded)	The chart review will determine the use of induction medication immediately prior to the epidural placement
Secondary	Opioid Use During Labor	The investigator will review the chart to see if the participant required opioids during labor (yes will be recorded)	A chart review of systemic opioids given to participant when the epidural is removed
Secondary	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)	Participants will be asked if they have had back pain for longer than a week immediately prior to epidural placement
Secondary	Number of Needle Repositions	The investigator will count the number epidural needle repositions during the epidural placement (whole number)	The number of needle reposition will be counted during epidural placement.
Secondary	Number of Needle Insertions	The investigator will count the number epidural needle insertions during the epidural placement (whole number)	The number of needle insertions will be counted during epidural placement.