Anesthesia, SpinalNCT03792191

Ultrasonography Versus Palpation for Spinal Anesthesia in Obese Parturients Undergoing Cesarean Delivery

A study testing Lumbar Spinal Ultrasonography, Conventional Landmark Palpation and Spinal Anesthesia in people with Anesthesia, Spinal and Cesarean Section, run by Mansoura University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study will compare between preprocedural ultrasonography and the conventional palpation technique for spinal anesthesia in obese parturients undergoing elective cesarean delivery Read more about this study

Who is it for?: Ages 19 years and older, women only
Conditions the study is for: Anesthesia, Spinal, Cesarean Section, Spinal Ultrasound
What is being tested?: Lumbar Spinal Ultrasonography, Conventional Landmark Palpation and Spinal Anesthesia
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 280 participants
Where: 1 siteEgypt
Study dates: 16 Jan 2019to 31 Jan 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 19 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

American Society of Anesthesiologists physical status II-III parturients
Full term singleton pregnancy
Body mass index ≥ 35 Kg/m2

Who cannot join

Age < 19 years
Women presenting in labor
Contraindications to neuraxial anesthesia (Coagulopathy, increased intracranial pressure, or local skin infection)
Significant spinal deformities or previous spinal surgery
Preeclampsia

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Department of Anesthesia, Mansoura University Hospitals
Al Mansurah, Dakahlia Governorate, 35511

Other trials in Egypt

About this study

The study will compare between preprocedural ultrasonography and the conventional palpation technique for spinal anesthesia in obese parturients undergoing elective cesarean delivery

Read the detailed description

This randomized, controlled, double-blind study will be conducted on ASA physical status II-III obese parturients with full-term singleton pregnancy undergoing elective cesarean delivery under spinal anesthesia. The study subjects will be assigned to 2 equal groups. In the ultrasonography group, lumbar spinal ultrasonography will be performed before administration of spinal anesthesia. In the palpation group, conventional palpation of the anatomical landmarks will be performed.

Conditions: Anesthesia, Spinal, Cesarean Section, Spinal Ultrasound
Being tested: Lumbar Spinal Ultrasonography, Sham Ultrasound Procedure, Conventional Landmark Palpation, Spinal Anesthesia, Intrathecal Bupivacaine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lumbar Spinal UltrasonographyRadiation
Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the intervertebral space with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 intervertebral spaces.
Sham Ultrasound ProcedureRadiation
Moving the ultrasound probe on the patient's back with the machine in the freeze position.
Conventional Landmark PalpationProcedure or surgery
Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) is assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest intervertebral space. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 intervertebral spaces.
Spinal AnesthesiaProcedure or surgery
Spinal anesthesia using a 25- or 22-gauge spinal needle
Intrathecal BupivacaineDrug
Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space
Intrathecal FentanylDrug
Fentanyl 15 μg will be administered in the subarachnoid space

Study groups in NCT03792191
Study group	Role	What they receive
Ultrasonography	Experimental	Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl. Receives: Radiation: Lumbar Spinal Ultrasonography; Procedure: Spinal Anesthesia; Drug: Intrathecal Bupivacaine; Drug: Intrathecal Fentanyl
Palpation	Active comparator	Sham ultrasound procedure. Conventional landmark palpation and skin marking.Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl. Receives: Radiation: Sham Ultrasound Procedure; Procedure: Conventional Landmark Palpation; Procedure: Spinal Anesthesia; Drug: Intrathecal Bupivacaine; Drug: Intrathecal Fentanyl

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Needle Passes Required to Obtain Free Cerebrospinal Fluid Flow
Needle pass is any forward introduction of the spinal needle after its complete or incomplete withdrawal, including the first attempt.
Measured: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes

Secondary outcomes (9)

Number of Skin Punctures Required to Obtain Free Cerebrospinal Fluid Flow
Skin puncture is any separate skin puncture by the spinal needle after its complete withdrawal, including the first attempt.
Measured: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes
Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Needle Pass
Needle pass is any forward introduction of the spinal needle after its complete or incomplete withdrawal, including the first attempt.
Measured: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes
Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Skin Puncture
Skin puncture is any separate skin puncture by the spinal needle after its complete withdrawal, including the first attempt.
Measured: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes
Duration of the Spinal Procedure
The duration from starting the first skin puncture by the spinal needle to obtaining free CSF flow
Measured: Assessed from enrollment in the study until completion of cesarean delivery
Patient Satisfaction
Patient satisfaction from the procedure assessed immediately after intrathecal injection using a 5-point scale (1 = very unsatisfied; 2 = unsatisfied; 3 = fair; 4 = satisfied; and 5 = very satisfied).
Measured: Assessed at 1 minute after intrathecal injection
Number of Participants With Vascular Puncture
Number of participants with unintentional vascular puncture by the needle during performing the spinal procedure
Measured: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes
Number of Participants With Paresthesia
Number of participants with paresthesia reported by the subjects during performing the spinal procedure
Measured: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes
Number of Participants With Failure to Obtain Free Cerebrospinal Fluid Flow
Number of participants with failure to obtain free cerebrospinal fluid flow after adequate needle passes at 6 separate skin punctures.
Measured: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes
Number of Participants With Failed Spinal Block
Number of participants with failed spinal block defined as an upper sensory level below T6 assessed by pinprick.
Measured: Assessed up to 20 minutes after intrathecal injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Jan 201931 Jan 2021

First posted3 Jan 2019
Study start16 Jan 2019
Primary completion31 Jan 2021
Study completion31 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Anesthesia, SpinalStudies of the same condition, open and under way.
More trials run by Mansoura 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: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 280 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03792191
Sponsor's protocol ID: MD.18.02.29
Status last verified: May 2021
First submitted: 1 Jan 2019
Last updated: 24 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Tawfik MM, Tolba MA, Ismail OM, Messeha MM. Ultrasonography versus palpation for spinal anesthesia in obese parturients undergoing cesarean delivery: a randomized controlled trial. Reg Anesth Pain Med. 2024 Jan 11;49(1):41-48. doi: 10.1136/rapm-2022-104272.
PubMed 37188389

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ultrasonography Versus Palpation for Spinal Anesthesia in Obese Parturients Undergoing Cesarean Delivery
ClinicalTrials.gov ID: NCT03792191
Acronym / sponsor ID: MD.18.02.29
Conditions: Anesthesia, Spinal, Cesarean Section, Spinal Ultrasound
Study type: Interventional
Recruitment status: Completed
Enrolment: 280 participants (actual)
Lead sponsor: Mansoura UniversityUniversity, hospital or other
Study start: 16 Jan 2019 (actual)
Primary completion: 31 Jan 2021 (actual)
Study completion: 31 Jan 2021 (actual)
First posted: 3 Jan 2019 (actual)
Results: Posted 24 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study will compare between preprocedural ultrasonography and the conventional palpation technique for spinal anesthesia in obese parturients undergoing elective cesarean delivery

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Ultrasonography	Experimental	Radiation: Lumbar Spinal Ultrasonography, Procedure: Spinal Anesthesia, Drug: Intrathecal Bupivacaine, Drug: Intrathecal FentanylPreprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl.
Palpation	Active comparator	Radiation: Sham Ultrasound Procedure, Procedure: Conventional Landmark Palpation, Procedure: Spinal Anesthesia, Drug: Intrathecal Bupivacaine, Drug: Intrathecal FentanylSham ultrasound procedure. Conventional landmark palpation and skin marking.Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl.

Who may qualify

Ages: 19 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

American Society of Anesthesiologists physical status II-III parturients
Full term singleton pregnancy
Body mass index ≥ 35 Kg/m2

Key exclusion criteria (5 listed)

Age < 19 years
Women presenting in labor
Contraindications to neuraxial anesthesia (Coagulopathy, increased intracranial pressure, or local skin infection)
Significant spinal deformities or previous spinal surgery
Preeclampsia

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
Lumbar Spinal UltrasonographyUltrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the intervertebral space with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 intervertebral spaces.	Radiation	Ultrasonography
Sham Ultrasound ProcedureMoving the ultrasound probe on the patient's back with the machine in the freeze position.	Radiation	Palpation
Conventional Landmark PalpationConventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) is assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest intervertebral space. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 intervertebral spaces.	Procedure or surgery	Palpation
Spinal AnesthesiaSpinal anesthesia using a 25- or 22-gauge spinal needle	Procedure or surgery	Palpation, Ultrasonography
Intrathecal BupivacaineBupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space	Drug	Palpation, Ultrasonography
Intrathecal FentanylFentanyl 15 μg will be administered in the subarachnoid space	Drug	Palpation, Ultrasonography

Primary outcome

Number of Needle Passes Required to Obtain Free Cerebrospinal Fluid Flow
Time frame: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes
Needle pass is any forward introduction of the spinal needle after its complete or incomplete withdrawal, including the first attempt.

9 secondary outcomes

Number of Skin Punctures Required to Obtain Free Cerebrospinal Fluid Flow
Time frame: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes
Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Needle Pass
Time frame: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes
Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Skin Puncture
Time frame: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes
Duration of the Spinal Procedure
Time frame: Assessed from enrollment in the study until completion of cesarean delivery
Patient Satisfaction
Time frame: Assessed at 1 minute after intrathecal injection
Number of Participants With Vascular Puncture
Time frame: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes
Number of Participants With Paresthesia
Time frame: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes
Number of Participants With Failure to Obtain Free Cerebrospinal Fluid Flow
Time frame: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes
Number of Participants With Failed Spinal Block
Time frame: Assessed up to 20 minutes after intrathecal injection

Results and safety

Results posted to the registry on 24 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ultrasonography	140	140
Palpation	140	140

Primary outcome: Number of Needle Passes Required to Obtain Free Cerebrospinal Fluid Flow

Time frame: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes. Median (Full Range). Unit: needle passes

Measure	Ultrasonography n = 140	Palpation n = 140
Value	3 (1 to 34)	3 (1 to 23)

Ultrasonography vs Palpation: Median Difference (Final Values): 0.00007 (95% CI -0.00005 to 1), p = 0.62, Wilcoxon (Mann-Whitney)

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment in the study until home discharge, up to 48 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ultrasonography	0 of 140 (0%)	0 of 140 (0%)	0 of 140
Palpation	0 of 140 (0%)	0 of 140 (0%)	0 of 140

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37188389Tawfik MM, Tolba MA, Ismail OM, Messeha MM. Ultrasonography versus palpation for spinal anesthesia in obese parturients undergoing cesarean delivery: a randomized controlled trial. Reg Anesth Pain Med. 2024 Jan 11;49(1):41-48. doi: 10.1136/rapm-2022-104272.
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.

Mohamed M Tawfik, MD study director

Mansoura University Hospital

Mohamed A Tolba, MSc principal investigator

Mansoura University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 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 24 May 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 Egypt. 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?

Yes. Results are posted in the registry (first posted 24 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Needle Passes Required to Obtain Free Cerebrospinal Fluid Flow (time frame: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes). 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 NCT03792191, 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 24 May 2021.