Back PainNCT02813681
Ultrasound-Guided Landmark and Epidural Site Pain
A study testing US-epidural SVD and Spontaneous vaginal delivery without an Epidural in people with Back Pain and Epidural Analgesia, Obstetric, run by The University of Texas Medical Branch, Galveston.
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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Back Pain, Epidural Analgesia, Obstetric
- What is being tested?
- US-epidural SVD and Spontaneous vaginal delivery without an Epidural
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- May 2014to May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- placental percreta
- placental increta
- placenta accreta
- preeclampsia
- eclampsia
About this study
Official title: A Prospective Randomized Clinical Trial to Study the Effect of Pre-Epidural Ultrasound Examination on Epidural Insertion Site Pressure Sensitivity in Parturient
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.
Read the 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
- Being tested
- US-epidural SVD, US sham- epidural SVD, Spontaneous vaginal delivery without an Epidural
- Keywords
- Acute Pain, ultrasonography
- Medical subject headings
- Back Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US-epidural SVDProcedure or surgery
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 SVDProcedure or surgery
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 EpiduralProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: Procedure: Spontaneous vaginal delivery without an Epidural |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidural Pressure Sensitivity at Level of Epidural Insertion
pressure sensitivity at level of epidural insertion will be measured with an algometer (Newtons)
Measured: 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 investigator will review the chart to see if the participant used of induction medication (answer yes will be recorded)
Measured: The chart review will determine the use of induction medication immediately prior to the epidural placement
Opioid Use During Labor
The investigator will review the chart to see if the participant required opioids during labor (yes will be recorded)
Measured: A chart review of systemic opioids given to participant when the epidural is removed
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)
Measured: 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 investigator will count the number epidural needle repositions during the epidural placement (whole number)
Measured: The number of needle reposition will be counted during epidural placement.
Number of Needle Insertions
The investigator will count the number epidural needle insertions during the epidural placement (whole number)
Measured: The number of needle insertions will be counted during epidural placement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study startMay 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Back PainStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denise Wilkes, Principal investigator, UTMB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813681
- Sponsor's protocol ID
- 14-0110
- Status last verified
- Jun 2016
- First submitted
- 16 Jun 2016
- Last updated
- 3 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Clinical Trial to Study the Effect of Pre-Epidural Ultrasound Examination on Epidural Insertion Site Pressure Sensitivity in Parturient
- ClinicalTrials.gov ID
- NCT02813681
- Acronym / sponsor ID
- 14-0110
- Conditions
- Back Pain, Epidural Analgesia, Obstetric
- Keywords
- Acute Pain, ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 27 Jun 2016 (estimated)
- Results
- Posted 3 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| US-epidural SVD | Active comparator | Procedure: US-epidural SVDUS-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 |
| (US sham- epidural SVD) | Sham comparator | Procedure: US sham- epidural SVDUS sham- epidural SVD group- participants who received US examination process but with the monitor turned off. |
| SVD without an Epidural | Placebo comparator | Procedure: Spontaneous vaginal delivery without an EpiduralSpontaneous vaginal delivery without an Epidural group The purpose of the control group is to serve as a baseline. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- pregnant with term (37 - 41 weeks) singleton gestation
- active labor
- history of normal pregnancy
- request an epidural
- age between 18 - 35 years old
Key exclusion criteria (11 listed)
- history of spinal surgery
- scoliosis
- epidural or spinal placement within the last 5 days
- neuropathic pain disorders
- chronic opioid use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| US-epidural SVDparticipants who received US examination prior to epidural placement. The purpose of this group is to determine if US derived landmarks reduce pressure sensitivity. | Procedure or surgery | US-epidural SVD |
| US sham- epidural SVDparticipants 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). | Procedure or surgery | (US sham- epidural SVD) |
| Spontaneous vaginal delivery without an EpiduralSpontaneous 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 | Procedure or surgery | SVD without an Epidural |
Primary outcome
Epidural Pressure Sensitivity at Level of Epidural Insertion
Time frame: 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.
pressure sensitivity at level of epidural insertion will be measured with an algometer (Newtons)
5 secondary outcomes
Induction Medication
Time frame: The chart review will determine the use of induction medication immediately prior to the epidural placement
Opioid Use During Labor
Time frame: A chart review of systemic opioids given to participant when the epidural is removed
Short-term Back Pain
Time frame: Participants will be asked if they have had back pain for longer than a week immediately prior to epidural placement
Number of Needle Repositions
Time frame: The number of needle reposition will be counted during epidural placement.
Number of Needle Insertions
Time frame: The number of needle insertions will be counted during epidural placement.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denise Wilkes principal investigator
UTMB
Questions about this trial
What is this clinical trial studying?
A study testing US-epidural SVD and Spontaneous vaginal delivery without an Epidural in people with Back Pain and Epidural Analgesia, Obstetric, run by The University of Texas Medical Branch, Galveston.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidural Pressure Sensitivity at Level of Epidural Insertion (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2019.