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Labor and DeliveryNCT02803450

Epidural Loading: High Volume, Low Concentration

A study testing Epidural needle and Catheter Administration in people with Labor and Delivery, run by Ohio State University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This prospective, randomized, single blinded control trial will investigate the effects of epidural loading with a high volume, low concentration local anesthetic solution via the epidural needle versus the epidural catheter. Read more about this study

Who is it for?
Ages 18 to 89 years, women onlyHealthy volunteers can take part
Conditions the study is for
Labor and Delivery
What is being tested?
Epidural needle and Catheter Administration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Feb 2016to Jan 2017
Phase
Interventional
Are there results?
None posted in the registry

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 89 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subjects who have volunteered and consented to participation in the study upon admission to labor and delivery
  • Parturients in active labor requesting epidural analgesia
  • Uncomplicated pregnancy with a reassuring fetal heart tracing
  • Age greater than or equal to 18 years

Who cannot join

  • Contraindication to epidural anesthesia
  • Inability to read, comprehend, and sign the informed consent form
  • Fetal intrauterine growth retardation (IUGR)
  • Non-reassuring fetal heart tracing
  • Cervical dilation greater than 7cm
  • Intra-uterine fetal demise
Show all 9Show fewer
  • History of chronic pain other than in the back
  • Incarcerated patients I. Any patient enrolled in the study in whom there is evidence of dural puncture during epidural technique (>3 attempts, presence of CSF)
  • Any evidence of high spinal after initial bolus or continuous infusion of high volume, low concentration local anesthetic solution k. Women undergoing cesarean section

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: Epidural Loading With High Volume, Low Concentration Prior to Catheter Insertion: is How You Administer the Volume Important?

This prospective, randomized, single blinded control trial will investigate the effects of epidural loading with a high volume, low concentration local anesthetic solution via the epidural needle versus the epidural catheter.

Read the detailed description

This prospective, randomized, single blinded control trial will investigate the effects of epidural loading with a high volume, low concentration local anesthetic solution via the epidural needle versus the epidural catheter. Control patients will receive local anesthetic in lower volume more concentrated solution via the epidural catheter which is current standard practice. Outcome measures will include quantifying pain relief with respect to time using VAS scores. In addition, post delivery patient satisfaction regarding anesthesia regimen, blood pressure changes, heart rate, anesthetic level, total dose of epidural used during labor, rescue doses and incidence of fetal bradycardia will be assessed. 35 patients will be recruited for each of the three arms of the study, totaling 105 patients, in order to obtain significance when performing statistical analyses following complete enrollment in the study. The impetus of this study involves investigation of the effects of loading the epidural space with high volume, low concentration local anesthetic via two different modalities and studying which method is more efficacious.

Being tested
Epidural needle, Catheter Administration, Standard of Care Epidural Administration
Keywords
Effects of; Anesthesia, spinal and epidural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Epidural needleProcedure or surgery

    Medication administration via epidural needle.

  • Catheter AdministrationProcedure or surgery

    Medication administration via epidural catheter.

  • Standard of Care Epidural AdministrationProcedure or surgery

    Also called Epidural catheter

    Medication administered at higher concentration, lower volume via epidural catheter.

Study groups in NCT02803450
Study groupRoleWhat they receive
High Volume, Low Concentration via Epidural NeedleExperimentalEpidural loading: Participants will receive 20ml of 0.0625% bupivacaine with fentanyl 1mcg/ml epidural loading dose in 10ml increments five minutes apart via epidural needle followed by catheter placement. For continuous infusions: The continuous patient controlled epidural anesthesia (PCEA) pump will contain 0.03125% bupivacaine with 1mcg/ml fentanyl. The infusion rate will be set at 20ml/hr basal rate and 8ml every 15 minutes on demand with lockout of 52ml/hr. For inadequate analgesia: One additional 10ml boluses of the experimental 0.0625% bupivacaine with 1mcg/ml will be provided spaced 5 minutes apart via the epidural catheter.
Receives: Procedure: Epidural needle
High Volume, Low Concentration via Epidural CatheterExperimentalEpidural loading: Participants will receive 20ml of 0.0625% bupivacaine with fentanyl 1mcg/ml epidural loading dose in 10ml increments five minutes apart via the epidural catheter administration following catheter placement. For continuous infusions: The continuous patient controlled epidural anesthesia (PCEA) pump will contain 0.03125% bupivacaine with 1mcg/ml fentanyl. The infusion rate will be set at 20ml/hr basal rate and 8ml every 15 minutes on demand with lockout of 52ml/hr. For inadequate analgesia: One additional 10ml boluses of the experimental 0.0625% bupivacaine with 1mcg/ml will be provided spaced 5 minutes apart via the epidural catheter.
Receives: Procedure: Catheter Administration
Low Volume, High Concentration via Epidural CatheterActive comparatorStandard of Care Epidural Administration Epidural loading: Participants will receive 10ml of 0.125% bupivacaine with fentanyl 2mcg/ml in 5 ml increments 5 minutes apart via the epidural catheter following epidural catheter placement, per standard of care. For continuous infusions: The continuous patient controlled epidural anesthesia (PCEA) pump will contain 0.0625% bupivacaine with 2mcg/ml fentanyl. The infusion rate will be set at 10ml/hr basal rate and 4ml every 15 minutes on demand with lockout of 26ml/hr. For inadequate analgesia: One additional 5ml boluses of the standard 0.125% bupivacaine with 2mcg/ml will be provided spaced 5 minutes apart via the epidural catheter.
Receives: Procedure: Standard of Care Epidural Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient Pain Levels (VAS Assessment)

    Patients will be assessed for pain levels on the VAS scale after analgesia administration in both arms

    Measured: During Labor

  2. Patient Satisfaction

    Patient satisfaction with analgesia using a Likert rating of patient satisfaction with anesthetic care.

    Measured: During labor

Secondary outcomes (5)

  1. Analgesic level

    Pinprick every 10, 15, and 20 minutes following loading

    Measured: 20 minutes

  2. Maternal Vital Signs

    Measure change in maternal blood pressure and heart rate over 20 minutes following loading.

    Measured: 20 minutes

  3. Fetal Heart Rate

    Measure change in fetal heart rate following loading.

    Measured: 20 minutes

  4. Rescue Bolus

    Measure number of rescue bolus doses and total anesthetic dose

    Measured: During Labor

  5. Intravascular Catheter Placement

    Measure incidence of intravascular catheter placement.

    Measured: During labor

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionJan 2017
  4. Study completionJan 2017

Why it stopped: The protocol will be rewritten.

Resources

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
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02803450
Sponsor's protocol ID
2013H0188
Status last verified
Sep 2021
First submitted
14 Jun 2016
Last updated
27 Sep 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Epidural needle and Catheter Administration in people with Labor and Delivery, run by Ohio State University at 1 site in United States.

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 4 inclusion and 9 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: withdrawn, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Patient Pain Levels (VAS Assessment) (time frame: During Labor). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02803450.

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 27 Sep 2021.

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