Epidural; AnesthesiaNCT04352283
Does Ultrasound Increase the First-pass Success of Epidural Space Identification in Obese Parturients
A study testing Preprocedural ultrasound exam of lumbar spine in people with Epidural; Anesthesia, run by University Hospital, Caen at 1 site in France.
Trial summary
Obesity is associated with difficulties in epidural space catheterization. The investigators want to prove that a pre-procedural ultrasound exam of lumbar spine increase the first-pass success rate of the epidural space identification among obese parturients. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Epidural; Anesthesia
- What is being tested?
- Preprocedural ultrasound exam of lumbar spine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- 6 Apr 2019to 28 Feb 2020
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Full-term parturients (≥ 37 weeks of amenorrhea)
- With pre-pregnancy BMI ≥ 30 kg/m2
- Admit for a vaginal delivery
- Receiving labour epidural analgesia
Who cannot join
- Usual contraindications for neuraxial anesthesia (thrombocytopenia, coagulopathy, uncorrected hypovolemia, infected puncture site, intracranial hypertension)
- Emergency maternal and foetal cases
- Twin pregnancy
- Marked spinal deformity ou previous spinal surgery
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Preprocedural Ultrasound Exam of Lumbar Spine Increase the First-pass Success Rate of Epidural Space Identification Among Obese Parturients: A Randomized Controlled Open Trial
Obesity is associated with difficulties in epidural space catheterization. The investigators want to prove that a pre-procedural ultrasound exam of lumbar spine increase the first-pass success rate of the epidural space identification among obese parturients.
Read the detailed description
This study was a randomized controlled open trial with two parallel groups.
Study was conducted in only one center : the maternity of University Hospital of Caen (Normandy, France)
Written informed consent was obtained from eligible subjects after the pre-anesthetic interview in the 8th month of pregnancy.
Operators were medical interns or residents in anesthesiology. Before inclusion, they all spent an individual interview in the aim to practice ultrasound exam of lumbar spine.
Eligible subjects were full-term parturients with pre-pregnancy BMI ≥ 30 kg/m2 undergoing vaginal delivery and receiving epidural labor analgesia. Exclusion criteria were usual contraindications for neuraxial anesthesia, marked spinal deformity, previous spinal surgery and emergency context.
The study subjects were randomly assigned to palpation or ultrasound using sealed opaque envelopes containing group allocation.
Standard monitors were applied and patients were positioned sitting during landmark identification and throughout the anesthetic procedure.
In control group, needle-puncture site was determinate by the conventional technique of cutaneous palpation. Conventional palpation of the anatomical landmarks was performed and the intercristal line (Tuffier) was assumed to cross the spine at L4 spinous process or L3-L4 interspace. The skin was marked with horizontal and vertical lines at the L3-L4 and L2-L3 interspaces.
In experimental group, ultrasound exam of lumbar spine allowed to determinate the puncture site. A systematic approach described by Balki [1] was performed, using a portative ultrasound device with a 5-2 MHz curved array probe (Samsung HM70A, Samsung medical France, St-Ouen, France).
The epidural space was located using a midline approach with loss of resistance (saline solution) using and 18-gauge Tuohy needle. After successful identification of the epidural space, a 20-gauge multiorifice epidural catheter was inserted through the Tuohy needle up to 5 cm into the epidural space.The epidural analgesia protocol was PCEA (Patient Controled Epidural Analgesia) using subsequent admixture : lévo-bupivacaïne (0,625 mg/ml), sufentanil (0,02 µ/ml), clonidine (37 µg/ml).
The primary outcome was the rate of successful epidural space identification at the first needle pass (one skin puncture without redirection).
Secondary outcomes are described further.
Early procedural complications and delivery modalities (C-section, forceps) were notified.
An interview was planned 48 hours after the procedure for each parturient in the aim to assess the maternal satisfaction and detect late procedure complications.
Assuming α = 0.05 and β = 0.2 (80% power) risks and using the χ2 test, 28 patients were required in each group.
- Conditions
- Epidural; Anesthesia
- Being tested
- Preprocedural ultrasound exam of lumbar spine
- Keywords
- ultrasound, obesity, epidural analgesia, vaginal delivery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preprocedural ultrasound exam of lumbar spineDevice
Preprocedural ultrasound exam of lumbar spine used to determinate needle puncture site
| Study group | Role | What they receive |
|---|---|---|
| palpation | No intervention | Usual method to determinate needle puncture site |
| Ultrasound | Experimental | Ultrasound preprocedural exam used to determinate needle puncture site Receives: Device: Preprocedural ultrasound exam of lumbar spine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of the epidural space identification at the first needle pass
Succes rate of the epidural space identification at the first needle pass (first skin puncture and without needle redirection) for each group
Measured: Baseline up to 1 hour
Secondary outcomes (11)
Success of the epidural space identification at the first skin puncture
Success rate of the epidural space identification at the first needle pass (first skin puncture with at least one redirection) for each group
Measured: Baseline up to 1 hour
Number of skin punctures
Number of skin punctures per parturient
Measured: Baseline up to 1 hour
Number of needle redirections
Number of needle redirections per parturient
Measured: Baseline up to 1 hour
Number of intervertebral space punctured
Number of intervertebral space punctured per parturient
Measured: Baseline up to 1 hour
Duration of the epidural procedure
Duration of the epidural procedure in seconds, measured from the first skin puncture to the test dose
Measured: Baseline up to 1 hour
Early Failed of the epidural analgesia
Early Failed epidural analgesia, defined by the epidural analgesia remplacement within 30 minutes
Measured: 30 minutes after the end of the procedure
Verbal Rating Scale
Verbal Rating Scale (VRS) of pain measured after the epidural procedure : from 0 (no itch) to 10 (worst imaginable itch)
Measured: 30 minutes and 120 minutes after the epidural procedure
Accidental Dural puncture
Occurence of accidental dural puncture during the epidural procedure
Measured: Baseline up to 1 hour
Post dural puncture headache
Occurence of Post dural puncture headache after the epidural procedure
Measured: 48 hours after the epidural procedure
Quality of epidural analgesia
Maternal perception of epidural analgesia quality during the labour : from 1 (very bad) to 5 (excellent)
Measured: 48 hours after the epidural procedure
Maternal perception of the duration of the epidural procedure
Maternal perception of epidural procedure duration : from 1(very short) to 5 (very long)
Measured: 48 hours after the epidural procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start6 Apr 2019
- Primary completion8 Apr 2019
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epidural; AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Model description
- randomized controlled open trial
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lise-Amelie ZERAJIC, MD, Principal investigator, Anesthesiologist Intensivist Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352283
- Sponsor's protocol ID
- 2018-A02752-53
- Status last verified
- Mar 2019
- First submitted
- 29 Mar 2020
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Balki M. Locating the epidural space in obstetric patients-ultrasound a useful tool: continuing professional development. Can J Anaesth. 2010 Dec;57(12):1111-26. doi: 10.1007/s12630-010-9397-y. Epub 2010 Nov 11. English, French.
PubMed 21063818
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Preprocedural Ultrasound Exam of Lumbar Spine Increase the First-pass Success Rate of Epidural Space Identification Among Obese Parturients: A Randomized Controlled Open Trial
- ClinicalTrials.gov ID
- NCT04352283
- Acronym / sponsor ID
- 2018-A02752-53
- Conditions
- Epidural; Anesthesia
- Keywords
- ultrasound, obesity, epidural analgesia, vaginal delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 6 Apr 2019 (actual)
- Primary completion
- 8 Apr 2019 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 20 Apr 2020 (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.
Obesity is associated with difficulties in epidural space catheterization. The investigators want to prove that a pre-procedural ultrasound exam of lumbar spine increase the first-pass success rate of the epidural space identification among obese parturients.
Detailed description
This study was a randomized controlled open trial with two parallel groups.
Study was conducted in only one center : the maternity of University Hospital of Caen (Normandy, France)
Written informed consent was obtained from eligible subjects after the pre-anesthetic interview in the 8th month of pregnancy.
Operators were medical interns or residents in anesthesiology. Before inclusion, they all spent an individual interview in the aim to practice ultrasound exam of lumbar spine.
Eligible subjects were full-term parturients with pre-pregnancy BMI ≥ 30 kg/m2 undergoing vaginal delivery and receiving epidural labor analgesia. Exclusion criteria were usual contraindications for neuraxial anesthesia, marked spinal deformity, previous spinal surgery and emergency context.
The study subjects were randomly assigned to palpation or ultrasound using sealed opaque envelopes containing group allocation.
Standard monitors were applied and patients were positioned sitting during landmark identification and throughout the anesthetic procedure.
In control group, needle-puncture site was determinate by the conventional technique of cutaneous palpation. Conventional palpation of the anatomical landmarks was performed and the intercristal line (Tuffier) was assumed to cross the spine at L4 spinous process or L3-L4 interspace. The skin was marked with horizontal and vertical lines at the L3-L4 and L2-L3 interspaces.
In experimental group, ultrasound exam of lumbar spine allowed to determinate the puncture site. A systematic approach described by Balki [1] was performed, using a portative ultrasound device with a 5-2 MHz curved array probe (Samsung HM70A, Samsung medical France, St-Ouen, France).
The epidural space was located using a midline approach with loss of resistance (saline solution) using and 18-gauge Tuohy needle. After successful identification of the epidural space, a 20-gauge multiorifice epidural catheter was inserted through the Tuohy needle up to 5 cm into the epidural space.The epidural analgesia protocol was PCEA (Patient Controled Epidural Analgesia) using subsequent admixture : lévo-bupivacaïne (0,625 mg/ml), sufentanil (0,02 µ/ml), clonidine (37 µg/ml).
The primary outcome was the rate of successful epidural space identification at the first needle pass (one skin puncture without redirection).
Secondary outcomes are described further.
Early procedural complications and delivery modalities (C-section, forceps) were notified.
An interview was planned 48 hours after the procedure for each parturient in the aim to assess the maternal satisfaction and detect late procedure complications.
Assuming α = 0.05 and β = 0.2 (80% power) risks and using the χ2 test, 28 patients were required in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled open trial
| Arm | Type | Receives |
|---|---|---|
| palpation | No intervention | –Usual method to determinate needle puncture site |
| Ultrasound | Experimental | Device: Preprocedural ultrasound exam of lumbar spineUltrasound preprocedural exam used to determinate needle puncture site |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Full-term parturients (≥ 37 weeks of amenorrhea)
- With pre-pregnancy BMI ≥ 30 kg/m2
- Admit for a vaginal delivery
- Receiving labour epidural analgesia
Key exclusion criteria (5 listed)
- Usual contraindications for neuraxial anesthesia (thrombocytopenia, coagulopathy, uncorrected hypovolemia, infected puncture site, intracranial hypertension)
- Emergency maternal and foetal cases
- Twin pregnancy
- Marked spinal deformity ou previous spinal surgery
- Refusal to participate
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 |
|---|---|---|
| Preprocedural ultrasound exam of lumbar spinePreprocedural ultrasound exam of lumbar spine used to determinate needle puncture site | Device | Ultrasound |
Primary outcome
Success of the epidural space identification at the first needle pass
Time frame: Baseline up to 1 hour
Succes rate of the epidural space identification at the first needle pass (first skin puncture and without needle redirection) for each group
11 secondary outcomes
Success of the epidural space identification at the first skin puncture
Time frame: Baseline up to 1 hour
Number of skin punctures
Time frame: Baseline up to 1 hour
Number of needle redirections
Time frame: Baseline up to 1 hour
Number of intervertebral space punctured
Time frame: Baseline up to 1 hour
Duration of the epidural procedure
Time frame: Baseline up to 1 hour
Early Failed of the epidural analgesia
Time frame: 30 minutes after the end of the procedure
Verbal Rating Scale
Time frame: 30 minutes and 120 minutes after the epidural procedure
Accidental Dural puncture
Time frame: Baseline up to 1 hour
Post dural puncture headache
Time frame: 48 hours after the epidural procedure
Quality of epidural analgesia
Time frame: 48 hours after the epidural procedure
Maternal perception of the duration of the epidural procedure
Time frame: 48 hours after the epidural procedure
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 5 May 2020.
- Results publication: PubMed 21063818Balki M. Locating the epidural space in obstetric patients-ultrasound a useful tool: continuing professional development. Can J Anaesth. 2010 Dec;57(12):1111-26. doi: 10.1007/s12630-010-9397-y. Epub 2010 Nov 11. English, French.
- 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.
Lise-Amelie ZERAJIC, MD principal investigator
Anesthesiologist Intensivist Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preprocedural ultrasound exam of lumbar spine in people with Epidural; Anesthesia, run by University Hospital, Caen at 1 site in France.
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 5 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 5 May 2020. 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 France. 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?
Success of the epidural space identification at the first needle pass (time frame: Baseline up to 1 hour). 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 NCT04352283, which also lists 1 linked publication.
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 May 2020.