Analgesia in LaborNCT04776512
Erector Spinae Plane Block Versus Classic Epidural Analgesia in Labor
A study testing ESP Block With Bupivacain and Epidural Analgesia in people with Analgesia in Labor, run by Mongi Slim Hospital.
Trial summary
Prosepective,Randomized, controlled study enrolling full termed parturients admitted for vaginal delivery. At the sencond stage of labor: 3cm of cervix dilatation, patients will be randomized in 2 groups: ESP group: patients will receive ultrasound guided, bilateral ESP Block performed at the level of the 3 rd Lumbar… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Analgesia in Labor
- What is being tested?
- ESP Block With Bupivacain and Epidural Analgesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 31 Jul 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Full termed parturients admitted for vaginal delivery
- singleton pregnancy
- No contraindications to perimedullar analgesia techniques
Who cannot join
- Indication to Cesarean section during labor period
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Lumbar Erector Spinae Plane Block Versus Classic Epidural Analgesia in Labor
Prosepective,Randomized, controlled study enrolling full termed parturients admitted for vaginal delivery.
At the sencond stage of labor: 3cm of cervix dilatation, patients will be randomized in 2 groups:
- ESP group: patients will receive ultrasound guided, bilateral ESP Block performed at the level of the 3 rd Lumbar transverse process.
- Epidural Analgesia Group: Patients will have a classic lumbar continuous epidural analgesia.
Read the detailed description
Prosepective,Randomized, controlled study enrolling full termed parturients admitted for vaginal delivery.
At the sencond stage of labor: 3cm of cervix dilatation, patients will be randomized in 2 groups:
- ESP group: patients will receive ultrasound guided, bilateral ESP Block performed at the level of the 3 rd Lumbar transverse process.
- Epidural Analgesia Group: Patients will have a classic lumbar continuous epidural analgesia.
For the first group: 20 ml of 0,375% isobaric Bupivacain solution will be injected bilaterally under ultrasound direct vision.
Concerning the second group, patients will have a continuous injection of 0,125% Bupivacain solution associated to 0,25 mcg of Sufentanil/ml through an epidural catheter in the L3-L4 or L4-L5 intervertebral space.
For the 2 groups, analgesia will be assessed during all the labor period hourly using the Visual Analog pain Score (VAS).
- Conditions
- Analgesia in Labor
- Being tested
- ESP Block With Bupivacain, Epidural Analgesia
- Keywords
- analgesia, vaginal delivery, ESP, EPIDURAL
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESP Block With BupivacainProcedure or surgery
bilateral lumbar ESP block using 0.375% Bupivacain
Epidural AnalgesiaProcedure or surgery
Continuous Lumbar Epidural analgesia With 0,125% Bupivacain+0,25 mcg/ml Sufentanil
| Study group | Role | What they receive |
|---|---|---|
| Epidural Analgesia | Experimental | Patients of this group Will receive an epidural analgesia through a lumbar epidural catheter Receives: Procedure: Epidural Analgesia |
| ESP Block | Experimental | Bilateral ESP block performed at the level of the 3 rd Lumbar transverse process. Receives: Procedure: ESP Block With Bupivacain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesia during labor
analgesia assessed using VAScore
Measured: change in VAS score 1 hour after the beginning of labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Mar 2021 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesia in LaborStudies 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
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
- NCT04776512
- Sponsor's protocol ID
- ESP versus Epidural analgesia
- Status last verified
- Feb 2021
- First submitted
- 23 Feb 2021
- Last updated
- 1 Mar 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 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbar Erector Spinae Plane Block Versus Classic Epidural Analgesia in Labor
- ClinicalTrials.gov ID
- NCT04776512
- Acronym / sponsor ID
- ESP versus Epidural analgesia
- Conditions
- Analgesia in Labor
- Keywords
- analgesia, vaginal delivery, ESP, EPIDURAL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mongi Slim HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 1 Mar 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.
Prosepective,Randomized, controlled study enrolling full termed parturients admitted for vaginal delivery.
At the sencond stage of labor: 3cm of cervix dilatation, patients will be randomized in 2 groups:
- ESP group: patients will receive ultrasound guided, bilateral ESP Block performed at the level of the 3 rd Lumbar transverse process.
- Epidural Analgesia Group: Patients will have a classic lumbar continuous epidural analgesia.
Detailed description
Prosepective,Randomized, controlled study enrolling full termed parturients admitted for vaginal delivery.
At the sencond stage of labor: 3cm of cervix dilatation, patients will be randomized in 2 groups:
- ESP group: patients will receive ultrasound guided, bilateral ESP Block performed at the level of the 3 rd Lumbar transverse process.
- Epidural Analgesia Group: Patients will have a classic lumbar continuous epidural analgesia.
For the first group: 20 ml of 0,375% isobaric Bupivacain solution will be injected bilaterally under ultrasound direct vision.
Concerning the second group, patients will have a continuous injection of 0,125% Bupivacain solution associated to 0,25 mcg of Sufentanil/ml through an epidural catheter in the L3-L4 or L4-L5 intervertebral space.
For the 2 groups, analgesia will be assessed during all the labor period hourly using the Visual Analog pain Score (VAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural Analgesia | Experimental | Procedure: Epidural AnalgesiaPatients of this group Will receive an epidural analgesia through a lumbar epidural catheter |
| ESP Block | Experimental | Procedure: ESP Block With BupivacainBilateral ESP block performed at the level of the 3 rd Lumbar transverse process. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Full termed parturients admitted for vaginal delivery
- singleton pregnancy
- No contraindications to perimedullar analgesia techniques
Key exclusion criteria (1 listed)
- Indication to Cesarean section during labor period
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 |
|---|---|---|
| ESP Block With Bupivacainbilateral lumbar ESP block using 0.375% Bupivacain | Procedure or surgery | ESP Block |
| Epidural AnalgesiaContinuous Lumbar Epidural analgesia With 0,125% Bupivacain+0,25 mcg/ml Sufentanil | Procedure or surgery | Epidural Analgesia |
Primary outcome
Analgesia during labor
Time frame: change in VAS score 1 hour after the beginning of labor
analgesia assessed using VAScore
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 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.
Questions about this trial
What is this clinical trial studying?
A study testing ESP Block With Bupivacain and Epidural Analgesia in people with Analgesia in Labor, run by Mongi Slim Hospital.
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 3 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: status not confirmed, as of the sponsor's last update on 1 Mar 2021. 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. 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 Mhamed Sami Mebazaa, Professor (0021622252589, msmebazaa@gamil.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesia during labor (time frame: change in VAS score 1 hour after the beginning of labor). 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 Mar 2021.