Ultrasound-Guided Landmark and Epidural Site Pain

NCT02813681 | Completed Results

• 1 other identifier: 14-0110
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Back Pain; Epidural Analgesia, Obstetric

Keywords

Acute Pain; ultrasonography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Induction Medication

  The chart review will determine the use of induction medication immediately prior to the epidural placement

• Opioid Use During Labor

  A chart review of systemic opioids given to participant when the epidural is removed

• Short-term Back Pain

  Participants will be asked if they have had back pain for longer than a week immediately prior to epidural placement

• Number of Needle Repositions

  The number of needle reposition will be counted during epidural placement.

• Number of Needle Insertions

  The number of needle insertions will be counted during epidural placement.

Study Arms (3)

US-epidural SVD

ACTIVE COMPARATOR

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

Procedure: US-epidural SVD

(US sham- epidural SVD)

SHAM COMPARATOR

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

Procedure: US sham- epidural SVD

SVD without an Epidural

PLACEBO COMPARATOR

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

Procedure: Spontaneous vaginal delivery without an Epidural

Interventions

US-epidural SVD 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-epidural SVD

US sham- epidural SVD 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).

(US sham- epidural SVD)

Spontaneous vaginal delivery without an Epidural 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

SVD without an Epidural

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

MeSH Terms

Conditions

Back Pain; Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Denise Wilkes
• Organization: University of Texas Medical Branch

dwilkes@utmb.edu

409-772-1221

Study Officials

• Denise Wilkes

  UTMB

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 27, 2016
• Study Start: May 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: October 3, 2019
• Results First Posted: October 3, 2019

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share