Administration Methods of Labor AnalgesiaNCT02883283
Epidural Loading Prior to Catheter Insertion
A study testing Epidural loading dose, Epidural catheter and Epidural needle in people with Administration Methods of Labor Analgesia, run by Ohio State University at 1 site in United States.
Trial summary
This study explores the potential for a more rapid onset of pain relief when drug administration is performed through the epidural needle, a technique of epidural loading that provides a rapid and reliable level of labor analgesia without the disadvantages of a combined spinal-epidural, and could add a valuable new… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Administration Methods of Labor Analgesia
- What is being tested?
- Epidural loading dose, Epidural catheter and Epidural needle
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to 23 Jan 2014
- 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 years and older
- 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≥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 10Show fewer
- any spinal pathology or neurologic disease
- history of chronic pain
- incarcerated patients
- any patient enrolled in the study in whom there is evidence of dural puncture during epidural technique (>3 attempts, presence of CSF).
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
Official title: Epidural Loading Prior to Catheter Insertion: An Alternative to the Combined Spinal-epidural Technique?
This study explores the potential for a more rapid onset of pain relief when drug administration is performed through the epidural needle, a technique of epidural loading that provides a rapid and reliable level of labor analgesia without the disadvantages of a combined spinal-epidural, and could add a valuable new tool to anesthesiologists.
Read the detailed description
This study explores the potential for a more rapid onset of pain relief when drug administration is performed through the epidural needle, a technique of epidural loading that provides a rapid and reliable level of labor analgesia without the disadvantages of a combined spinal-epidural, and could add a valuable new tool to anesthesiologists. Investigators propose to conduct a single blinded, randomized controlled trial to determine if a difference exists in the speed of onset and spread of labor analgesia between patients receiving an epidural loading dose through the epidural needle or catheter.
Group 1 (Epidural Catheter Administration) participants will receive the 10 mL epidural loading dose in 5 mL increments via the epidural catheter following catheter placement (current standard practice).
Group 2 (Epidural Needle Administration ) participants will receive the 10 mL epidural loading dose in 5 mL increments via the epidural needle prior to catheter placement (experimental group).
Various parameters will be measured in the time after drug administration to evaluate blood pressure, heart rate, and fetal heart rate. Following delivery, the total anesthetic dose, total number of doses demanded, total number and dosage of rescue doses, and overall patient satisfaction will be recorded.
- Being tested
- Epidural loading dose, Epidural catheter, Epidural needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural loading doseProcedure or surgery
Labor epidural analgesia loading dose
Epidural catheterDevice
Epidural loading dose via epidural catheter
Epidural needleDevice
Epidural loading dose via epidural needle
| Study group | Role | What they receive |
|---|---|---|
| Epidural Catheter Administration | Active comparator | Participants will receive the 10 mL epidural loading dose in 5 mL increments via the epidural catheter following catheter placement. (Current standard practice) Epidural loading dose via epidural catheter. Receives: Procedure: Epidural loading dose; Device: Epidural catheter |
| Epidural Needle Administration | Experimental | Participants will receive the 10 mL epidural loading dose in 5 mL increments via the epidural needle prior to catheter placement. Epidural loading dose via epidural needle. Receives: Procedure: Epidural loading dose; Device: Epidural needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean VAS pain score
Mean VAS pain score will be determined 20 minutes following epidural loading, including assessments at 5, 10, 15, and 20 minutes.
Measured: 20 minutes
Secondary outcomes (8)
Analgesic level
Analgesic level assessed by pinprick at 10, 15 and 20 minutes following loading
Measured: 10, 15, and 20 minutes
Maternal Blood Pressure
Change in maternal blood pressure loading
Measured: Baseline and 20 minutes
Fetal Heart Rate
Change in fetal heart rate over 20 minutes following loading
Measured: Baseline and 20 minutes
Rescue Bolus Count
Number of rescue bolus doses will be counted
Measured: During Labor
Analgesia Satisfaction
Overall patient satisfaction with analgesia following delivery via questionnaire
Measured: During labor
Intravascular catheter placement
Incidence of intravascular catheter placement
Measured: During labor
Total anesthetic dose required
The total anesthetic dose during labor will be calculated
Measured: During Labor
Maternal Heart Rate
Change in maternal heart rate
Measured: Baseline and 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startJan 2013
- Primary completionJan 2014
- Study completion23 Jan 2014
Why it stopped: It was decided that this study was not feasible at our institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Administration Methods of Labor AnalgesiaStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Goran Ristev, Ohio State University
- Investigators
- Goran Ristev, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883283
- Sponsor's protocol ID
- 2012H0314
- Status last verified
- Sep 2021
- First submitted
- 9 May 2016
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Loading Prior to Catheter Insertion: An Alternative to the Combined Spinal-epidural Technique?
- ClinicalTrials.gov ID
- NCT02883283
- Acronym / sponsor ID
- 2012H0314
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: It was decided that this study was not feasible at our institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Jan 2014 (actual)
- Study completion
- 23 Jan 2014 (actual)
- First posted
- 30 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study explores the potential for a more rapid onset of pain relief when drug administration is performed through the epidural needle, a technique of epidural loading that provides a rapid and reliable level of labor analgesia without the disadvantages of a combined spinal-epidural, and could add a valuable new tool to anesthesiologists.
Detailed description
This study explores the potential for a more rapid onset of pain relief when drug administration is performed through the epidural needle, a technique of epidural loading that provides a rapid and reliable level of labor analgesia without the disadvantages of a combined spinal-epidural, and could add a valuable new tool to anesthesiologists. Investigators propose to conduct a single blinded, randomized controlled trial to determine if a difference exists in the speed of onset and spread of labor analgesia between patients receiving an epidural loading dose through the epidural needle or catheter.
Group 1 (Epidural Catheter Administration) participants will receive the 10 mL epidural loading dose in 5 mL increments via the epidural catheter following catheter placement (current standard practice).
Group 2 (Epidural Needle Administration ) participants will receive the 10 mL epidural loading dose in 5 mL increments via the epidural needle prior to catheter placement (experimental group).
Various parameters will be measured in the time after drug administration to evaluate blood pressure, heart rate, and fetal heart rate. Following delivery, the total anesthetic dose, total number of doses demanded, total number and dosage of rescue doses, and overall patient satisfaction will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural Catheter Administration | Active comparator | Procedure: Epidural loading dose, Device: Epidural catheterParticipants will receive the 10 mL epidural loading dose in 5 mL increments via the epidural catheter following catheter placement. (Current standard practice) Epidural loading dose via epidural catheter. |
| Epidural Needle Administration | Experimental | Procedure: Epidural loading dose, Device: Epidural needleParticipants will receive the 10 mL epidural loading dose in 5 mL increments via the epidural needle prior to catheter placement. Epidural loading dose via epidural needle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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≥18 years
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| Epidural loading doseLabor epidural analgesia loading dose | Procedure or surgery | Epidural Catheter Administration, Epidural Needle Administration |
| Epidural catheterEpidural loading dose via epidural catheter | Device | Epidural Catheter Administration |
| Epidural needleEpidural loading dose via epidural needle | Device | Epidural Needle Administration |
Primary outcome
Mean VAS pain score
Time frame: 20 minutes
Mean VAS pain score will be determined 20 minutes following epidural loading, including assessments at 5, 10, 15, and 20 minutes.
8 secondary outcomes
Analgesic level
Time frame: 10, 15, and 20 minutes
Maternal Blood Pressure
Time frame: Baseline and 20 minutes
Fetal Heart Rate
Time frame: Baseline and 20 minutes
Rescue Bolus Count
Time frame: During Labor
Analgesia Satisfaction
Time frame: During labor
Intravascular catheter placement
Time frame: During labor
Total anesthetic dose required
Time frame: During Labor
Maternal Heart Rate
Time frame: Baseline and 20 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- 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.
Goran Ristev, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural loading dose, Epidural catheter and Epidural needle in people with Administration Methods of Labor Analgesia, 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 10 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?
Mean VAS pain score (time frame: 20 minutes). 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 27 Sep 2021.