Ultrasound-Guided Landmark and Epidural Site Pain

The University of Texas System (UT)

Status: Completed

Conditions: Back Pain; Epidural Analgesia, Obstetric

Treatments: Procedure: US-epidural SVD; Procedure: Spontaneous vaginal delivery without an Epidural; Procedure: US sham- epidural SVD

Study type: Interventional

Funder types: Other

Identifiers

NCT02813681

14-0110

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 3 patient groups, including a placebo group

US-epidural SVD

Active Comparator group

Description:

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

Treatment:

Procedure: US-epidural SVD

(US sham- epidural SVD)

Sham Comparator group

Description:

US sham- epidural SVD group- participants who received US examination process but with the monitor turned off.

Treatment:

Procedure: US sham- epidural SVD

SVD without an Epidural

Placebo Comparator group

Description:

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

Treatment:

Procedure: Spontaneous vaginal delivery without an Epidural