Epidural; AnalgesiaNCT04826120
Continuous Versus Intermittent Administration of Epidural Analgesia During Labor
A study testing PCEA Infusion and Continuous epidural infusion in people with Epidural; Analgesia, run by Mongi Slim Hospital at 2 sites in Tunisia.
Trial summary
prospective randomized single blind study, including full term adult parturients, ASA 2, 3 status, scheduled for vaginal delivery. patients were randomized at 3 cm of cervix dilatation, into 2 groups. Epidural analgesia was initiated and maintained with a solution of Bupivacaine 0,125% and Sufentanil 0,25 mcg/ml. Read more about this study
- Who is it for?
- Ages 17 years and older, women only
- Conditions the study is for
- Epidural; Analgesia
- What is being tested?
- PCEA Infusion and Continuous epidural infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesTunisia
- Study dates
- 1 Jun 2020to 31 Jan 2021
- 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 17 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Full term parturients scheduled for vaginal delivery
Who cannot join
- patients in whom cesarean section delivery was indicated during labor
Trial locations and contacts
2 sites in 1 country.
Tunisia2 sites
Mongi Slim University Hospital
La Marsa, Tunis Governorate, 2046
Mongi Slim Hospital
Tunis, 2046
About this study
prospective randomized single blind study, including full term adult parturients, ASA 2, 3 status, scheduled for vaginal delivery. patients were randomized at 3 cm of cervix dilatation, into 2 groups.
Epidural analgesia was initiated and maintained with a solution of Bupivacaine 0,125% and Sufentanil 0,25 mcg/ml. After an initial bolus of 16 ML, patients were randomly assigned to receive intermittent boluses of 8 ml every 60 minutes after the initial dose followed by supplementary PCEA boluses of 8 ml for the first group ( PCEA group) or a continuous epidural infusion at the rate of 8 ml/h adjustable and starting immediately after The initial bolus of 16 ml for patients of the second group (CEI Group).
Read the detailed description
prospective randomized single blind study, including full term adult parturients, ASA 2, 3 status, scheduled for vaginal delivery. patients were randomized at 3 cm of cervix dilatation, into 2 groups.
Epidural analgesia was initiated and maintained with a solution of Bupivacaine 0,125% and Sufentanil 0,25 mcg/ml. After an initial bolus of 16 ML, patients were randomly assigned to receive intermittent boluses of 8 ml every 60 minutes after the initial dose followed by supplementary PCEA boluses of 8 ml for the first group ( PCEA group) or a continuous epidural infusion at the rate of 8 ml/h adjustable and starting immediately after The initial bolus of 16 ml for patients of the second group (CEI Group).
The main outcome of this study was: the incidence of motor Blockage. Our secondary outcomes were: maternal satisfaction, local anaesthetic and sufentanil cumulated doses, duration of the second stage of labor, mode of delivery and pain during labor using the Visual analogic score (VAS score).
- Conditions
- Epidural; Analgesia
- Being tested
- PCEA Infusion, Continuous epidural infusion
- Keywords
- Epidural, Analgesia, Labor, delivery
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCEA InfusionProcedure or surgery
Patients of this group Had PCEA during the second stage of labor
Continuous epidural infusionProcedure or surgery
Patients of this group Had continuous epidural infusion during the second stage of labor
| Study group | Role | What they receive |
|---|---|---|
| PCEA group | Active comparator | Patients of this group had intermittent epidural analgesia via PCEA associated to systematic 8 ml boluses every 60 min during the second stage of labor. Receives: Procedure: PCEA Infusion |
| CEI Group | Experimental | Patients of this group had continuous epidural infusion at the rate of 8 ml/h during the second stage of labor. Receives: Procedure: Continuous epidural infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of motor Blockage
Bromage scale 1, 2 or 3
Measured: during the epidural analgesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Jun 2020
- Primary completion31 Dec 2020
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidural; AnalgesiaStudies 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
- Model description
- parturients randomized in 2 groups and receiving 2 different interventions
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mongi Slim Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mhamed Sami Mebazaa, Mongi Slim Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826120
- Sponsor's protocol ID
- Epidural in Labor
- Status last verified
- Mar 2021
- First submitted
- 26 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Versus Intermittent Administration of Epidural Analgesia During Labor
- ClinicalTrials.gov ID
- NCT04826120
- Acronym / sponsor ID
- Epidural in Labor
- Conditions
- Epidural; Analgesia
- Keywords
- Epidural, Analgesia, Labor, delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Mongi Slim HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 1 Apr 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.
prospective randomized single blind study, including full term adult parturients, ASA 2, 3 status, scheduled for vaginal delivery. patients were randomized at 3 cm of cervix dilatation, into 2 groups.
Epidural analgesia was initiated and maintained with a solution of Bupivacaine 0,125% and Sufentanil 0,25 mcg/ml. After an initial bolus of 16 ML, patients were randomly assigned to receive intermittent boluses of 8 ml every 60 minutes after the initial dose followed by supplementary PCEA boluses of 8 ml for the first group ( PCEA group) or a continuous epidural infusion at the rate of 8 ml/h adjustable and starting immediately after The initial bolus of 16 ml for patients of the second group (CEI Group).
Detailed description
prospective randomized single blind study, including full term adult parturients, ASA 2, 3 status, scheduled for vaginal delivery. patients were randomized at 3 cm of cervix dilatation, into 2 groups.
Epidural analgesia was initiated and maintained with a solution of Bupivacaine 0,125% and Sufentanil 0,25 mcg/ml. After an initial bolus of 16 ML, patients were randomly assigned to receive intermittent boluses of 8 ml every 60 minutes after the initial dose followed by supplementary PCEA boluses of 8 ml for the first group ( PCEA group) or a continuous epidural infusion at the rate of 8 ml/h adjustable and starting immediately after The initial bolus of 16 ml for patients of the second group (CEI Group).
The main outcome of this study was: the incidence of motor Blockage. Our secondary outcomes were: maternal satisfaction, local anaesthetic and sufentanil cumulated doses, duration of the second stage of labor, mode of delivery and pain during labor using the Visual analogic score (VAS score).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- parturients randomized in 2 groups and receiving 2 different interventions
| Arm | Type | Receives |
|---|---|---|
| PCEA group | Active comparator | Procedure: PCEA InfusionPatients of this group had intermittent epidural analgesia via PCEA associated to systematic 8 ml boluses every 60 min during the second stage of labor. |
| CEI Group | Experimental | Procedure: Continuous epidural infusionPatients of this group had continuous epidural infusion at the rate of 8 ml/h during the second stage of labor. |
Who may qualify
- Ages
- 17 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Full term parturients scheduled for vaginal delivery
Key exclusion criteria (1 listed)
- patients in whom cesarean section delivery was indicated during labor
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 |
|---|---|---|
| PCEA InfusionPatients of this group Had PCEA during the second stage of labor | Procedure or surgery | PCEA group |
| Continuous epidural infusionPatients of this group Had continuous epidural infusion during the second stage of labor | Procedure or surgery | CEI Group |
Primary outcome
Incidence of motor Blockage
Time frame: during the epidural analgesia
Bromage scale 1, 2 or 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCEA Infusion and Continuous epidural infusion in people with Epidural; Analgesia, run by Mongi Slim Hospital at 2 sites in Tunisia.
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 1 inclusion and 1 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 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Tunisia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of motor Blockage (time frame: during the epidural analgesia). 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 1 Apr 2021.