Ultrasound-Guided Landmark and Epidural Site Pain

NCT ID: NCT02813681

Last Updated: 2019-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-05-31

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.

Conditions

Back Pain; Epidural Analgesia, Obstetric

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

US-epidural SVD

Intervention Type: PROCEDURE

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)

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

Group Type: SHAM_COMPARATOR

US sham- epidural SVD

Intervention Type: PROCEDURE

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).

SVD without an Epidural

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

Group Type: PLACEBO_COMPARATOR

Spontaneous vaginal delivery without an Epidural

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: 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).

Intervention Type: 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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Denise Wilkes

Role: PRINCIPAL_INVESTIGATOR

UTMB

Other Identifiers

14-0110

Identifier Type: -

Identifier Source: org_study_id