Labor PainNCT05034211
A Comparison Between 2 Methods of Local Anesthetic Administration for Maintaining Labor Analgesia After Dural Puncture Epidural
A study testing Programmed intermittent bolus epidural and Provider administered analgesia on patient request in people with Labor Pain and Epidural, run by Aretaieio Hospital at 1 site in Greece.
Trial summary
Intermittent epidural bolus technique opens a new era of interest for maintaining labor anlagesia. The study examines programmed intermittent epidural bolus technique on a scheduled basis to provider-administered bolus anlgesia on patient request, after a dural puncture epidural technique. Read more about this study
- Who is it for?
- Ages 20 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain, Epidural, Pain, Labor
- What is being tested?
- Programmed intermittent bolus epidural and Provider administered analgesia on patient request
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 1 Oct 2021to 1 Jun 2022
- 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 20 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- -nulliparous women
- 38th week of gestation
Who cannot join
- patient refusal to have an epidural
- patient refusal to participate
- contraindication for epidural
- ASA>3
- neurologic deficit/impairment
- allergy on local anesthetic chronic pain syndromes
Trial locations and contacts
1 site in 1 country.
Polyxeni Theodosopoulou, MD contact
Greece1 site, 1 recruiting
- Recruiting
Aretaieio Hospital
Athens, Attica, 11528
Anteia Paraskeva, Dr
Polyxeni Theodosopoulou, MD, xeniathd@gmail.com
About this study
Intermittent epidural bolus technique opens a new era of interest for maintaining labor anlagesia. The study examines programmed intermittent epidural bolus technique on a scheduled basis to provider-administered bolus anlgesia on patient request, after a dural puncture epidural technique.
Read the detailed description
After dural puncture, an epidural catheter will be placed on nulliparous women between 38 and 40 weeks of gestation presenting for labor . All will receive an test dose of 3ml lidocaine 2%, for properly checking the catheter placement and then an initial dose of 10ml ropivacaine 0,2% with 2 mcg/ml fentanyl. After that, women will be randomly assigned on two groups. Both groups will be receiving the same dose of analgesia (10ml ropivacaine 0,2% plus 1,5 mcg/ml fentanyl. However, one group will be receiving them on scheduled time intervals as programmed intermittent boluses every 60minutes and the other only on patient request for pain relief.
Pain scores, satisfaction, time for adequate analgesia, bromage scores,apgar scores, fetal arterial blood gases, time for delivery and type of delivery will be studied
- Conditions
- Labor Pain, Epidural, Pain, Labor
- Being tested
- Programmed intermittent bolus epidural, Provider administered analgesia on patient request
- Keywords
- dural puncture, programmed intermittent bolus, labor analgesia
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Programmed intermittent bolus epiduralProcedure or surgery
one arm will receive programmed intermittent boluses of local anesthetic via the epidural catheter on fixed time intervals. Standard 27G Tuohy needle epidural set with epidural catheter insertion on L2-L3 site, with the patient either sitting or in the lateral decubitus position will be used. Local injection with 6 ml lidocaine 2% will be performed before the insertion of the epidural needle
Provider administered analgesia on patient requestProcedure or surgery
one arm will receive bolus of local anesthetic via the catheter upon patient request. Standard 27G Tuohy needle epidural set with epidural catheter insertion on L2-L3 site, with the patient either sitting or in the lateral decubitus position will be used. Local injection with 6 ml lidocaine 2% will be performed before the insertion of the epidural needle
| Study group | Role | What they receive |
|---|---|---|
| Programmed intermittent Bolus Epidural technique | Active comparator | 10ml ropivacaine 0,2% and 1,5 mcg/ml fentanyl, will be administered every 60 minutes via an epidural catheter placed for labor analgesia on L2-L3/L3-L4 level Receives: Procedure: Programmed intermittent bolus epidural |
| Provider administered bolus epidural technique on patient request | Active comparator | 10ml ropivacaine 0,2% and 1,5 mcg/ml fentanyl, will be administered by the provider on patient request Receives: Procedure: Provider administered analgesia on patient request |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total local anesthetic and opioid administration
the total mg of local anesthetic and opioid consumed via the epidural catheter until the neonate delivery
Measured: 24hours
Secondary outcomes (8)
time needed for delivery
how long will it take for the baby to be delivered(in minutes)
Measured: 24hours
total patient satisfaction
from a scale of 0 to 10, higher score signifies better outcome
Measured: 24hours
apgar score
a test given to newborns soon after birth. This test checks a baby's heart rate, muscle tone, and other signs to see if extra medical care or emergency care is needed. The test is usually given twice: once at 1 minute after birth, and again at 5 minutes after birth.The higher the score the better the baby's condition willl be (the scale is from 0 to 10)
Measured: 24hours
Bromage score
This scale assesses the intensity of motor block by the patient's ability to move their lower extremities. O signifies free movement and 4 complete paralysis(higher score means worse outcome)
Measured: 24hours
type of delivery
whether it will be vaginal delivery, vaginal assisted delivery with instruments or a cesarean section
Measured: 24hours
neonatal arterial blood gases
when the baby will be delivered, a neonatal arterial blood gas will be measured
Measured: 24hours
time for sucessful level of analgesia
the time needed after epidural bolus to reach a scale below 3 on the NRS scale for pain assesment
Measured: 24hours
Pain score(NRS scale)
n a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10 . O represents no pain and 10 the worst pain ever possible
Measured: 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start1 Oct 2021 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aretaieio Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Polyxeni Theodosopoulou, Aretaieio Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034211
- Sponsor's protocol ID
- 342/25/5/21
- Status last verified
- Aug 2021
- First submitted
- 15 Jun 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between 2 Methods of Local Anesthetic Administration for Maintaining Labor Analgesia After Dural Puncture Epidural
- ClinicalTrials.gov ID
- NCT05034211
- Acronym / sponsor ID
- 342/25/5/21
- Conditions
- Labor Pain, Epidural, Pain, Labor
- Keywords
- dural puncture, programmed intermittent bolus, labor analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aretaieio HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 5 Sep 2021 (actual)
- 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.
Intermittent epidural bolus technique opens a new era of interest for maintaining labor anlagesia. The study examines programmed intermittent epidural bolus technique on a scheduled basis to provider-administered bolus anlgesia on patient request, after a dural puncture epidural technique.
Detailed description
After dural puncture, an epidural catheter will be placed on nulliparous women between 38 and 40 weeks of gestation presenting for labor . All will receive an test dose of 3ml lidocaine 2%, for properly checking the catheter placement and then an initial dose of 10ml ropivacaine 0,2% with 2 mcg/ml fentanyl. After that, women will be randomly assigned on two groups. Both groups will be receiving the same dose of analgesia (10ml ropivacaine 0,2% plus 1,5 mcg/ml fentanyl. However, one group will be receiving them on scheduled time intervals as programmed intermittent boluses every 60minutes and the other only on patient request for pain relief.
Pain scores, satisfaction, time for adequate analgesia, bromage scores,apgar scores, fetal arterial blood gases, time for delivery and type of delivery will be studied
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Programmed intermittent Bolus Epidural technique | Active comparator | Procedure: Programmed intermittent bolus epidural10ml ropivacaine 0,2% and 1,5 mcg/ml fentanyl, will be administered every 60 minutes via an epidural catheter placed for labor analgesia on L2-L3/L3-L4 level |
| Provider administered bolus epidural technique on patient request | Active comparator | Procedure: Provider administered analgesia on patient request10ml ropivacaine 0,2% and 1,5 mcg/ml fentanyl, will be administered by the provider on patient request |
Who may qualify
- Ages
- 20 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- -nulliparous women
- 38th week of gestation
Key exclusion criteria (6 listed)
- patient refusal to have an epidural
- patient refusal to participate
- contraindication for epidural
- ASA>3
- neurologic deficit/impairment
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 |
|---|---|---|
| Programmed intermittent bolus epiduralone arm will receive programmed intermittent boluses of local anesthetic via the epidural catheter on fixed time intervals. Standard 27G Tuohy needle epidural set with epidural catheter insertion on L2-L3 site, with the patient either sitting or in the lateral decubitus position will be used. Local injection with 6 ml lidocaine 2% will be performed before the insertion of the epidural needle | Procedure or surgery | Programmed intermittent Bolus Epidural technique |
| Provider administered analgesia on patient requestone arm will receive bolus of local anesthetic via the catheter upon patient request. Standard 27G Tuohy needle epidural set with epidural catheter insertion on L2-L3 site, with the patient either sitting or in the lateral decubitus position will be used. Local injection with 6 ml lidocaine 2% will be performed before the insertion of the epidural needle | Procedure or surgery | Provider administered bolus epidural technique on patient request |
Primary outcome
Total local anesthetic and opioid administration
Time frame: 24hours
the total mg of local anesthetic and opioid consumed via the epidural catheter until the neonate delivery
8 secondary outcomes
time needed for delivery
Time frame: 24hours
total patient satisfaction
Time frame: 24hours
apgar score
Time frame: 24hours
Bromage score
Time frame: 24hours
type of delivery
Time frame: 24hours
neonatal arterial blood gases
Time frame: 24hours
time for sucessful level of analgesia
Time frame: 24hours
Pain score(NRS scale)
Time frame: 24hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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.
Polyxeni Theodosopoulou, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Programmed intermittent bolus epidural and Provider administered analgesia on patient request in people with Labor Pain and Epidural, run by Aretaieio Hospital at 1 site in Greece.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 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 Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anteia Paraskeva, Dr (306972868078, aparask@med.uoa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total local anesthetic and opioid administration (time frame: 24hours). 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 5 Sep 2021.