Ultrasound GuidanceNCT07327801
The Impact of Ultrasound-Guided Spinal Anesthesia
A study testing Conventional spinal anesthesia and Ultrasound-guided spinal anesthesia in people with Ultrasound Guidance and Spinal Anesthesia, run by Military Hospital of Tunis at 1 site in Tunisia.
Trial summary
Neuraxial anesthesia is a commonly employed technique for subumbilical surgical procedures due to its effectiveness and safety profile. The advent of ultrasound technology has introduced the possibility of visualizing anatomical landmarks in real time, thereby facilitating more accurate and potentially safer… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ultrasound Guidance, Spinal Anesthesia, Procedural Performance
- What is being tested?
- Conventional spinal anesthesia and Ultrasound-guided spinal anesthesia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Feb 2025to 30 Jul 2025
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older.
- Classified as American Society of Anesthesiologists (ASA) physical status I or II.
- Scheduled for elective surgery under spinal anesthesia.
- Provided written informed consent.
Who cannot join
- Failed subarachnoid puncture.
- Conversion to general anesthesia.
- Occurrence of major intraoperative complications (e.g., vasovagal episodes, cardiac rhythm disturbances).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Ultrasound Guidance on the Performance of Spinal Anesthesia
Neuraxial anesthesia is a commonly employed technique for subumbilical surgical procedures due to its effectiveness and safety profile. The advent of ultrasound technology has introduced the possibility of visualizing anatomical landmarks in real time, thereby facilitating more accurate and potentially safer subarachnoid punctures. This study aims to compare conventional spinal anesthesia, based on palpation, with ultrasound-guided spinal anesthesia, focusing on procedural ease and overall facilitation.
it's a prospective, single-center, randomized, single-blind study. We included patients aged 18 years or older, classified as ASA I or II, scheduled for elective surgery, and who provided written informed consent. Exclusion criteria included failed subarachnoid puncture, conversion to general anesthesia, or the occurrence of major intraoperative complications such as vasovagal episodes or cardiac rhythm disturbances. Participants were randomly assigned, based on a randomization table, into two groups: Group1 (traditional technique), in which spinal anesthesia was performed using the conventional palpation-based method for space localization; and Group2 (ultrasound-guided technique), in which spinal anesthesia was performed under real-time ultrasound guidance. The primary outcome was the total procedure time, measured in seconds from the end of skin antisepsis to the initiation of subarachnoid injection. Secondary outcomes included the number of puncture attempts, the number of needle redirections within the same interspace, the occurrence of procedural incidents, and postoperative complaints such as radicular pain, osseous contact pain, intraoperative paresthesias, and traumatic punctures.
- Conditions
- Ultrasound Guidance, Spinal Anesthesia, Procedural Performance, Conventional Palpation Technique
- Being tested
- Conventional spinal anesthesia, Ultrasound-guided spinal anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional spinal anesthesiaDevice
The spinous processes were then palpated to precisely locate the targeted intervertebral space
Ultrasound-guided spinal anesthesiaDevice
A combined sequence was used, beginning with a longitudinal paramedian scan, followed by a 90-degree rotation to obtain a transverse interspinous view. This allowed for the identification of the spinal canal, after which the puncture was performed using dynamic, out-of-plane guidance
| Study group | Role | What they receive |
|---|---|---|
| Conventional spinal anesthesia | Active comparator | The operator began by palpating the posterior superior iliac spines to mentally determine the Tuffier's line, which roughly corresponds to the L4-L5 intervertebral space. The spinous processes were then palpated to precisely locate the targeted intervertebral space. The needle was subsequently inserted until cerebrospinal fluid return was obtained, and the anesthetic agent was administered slowly Receives: Device: Conventional spinal anesthesia |
| Ultrasound-guided spinal anesthesia | Active comparator | The operator set up the sterile equipment, which included an ultrasound machine equipped with a low-frequency convex probe (2-5 MHz). The probe, previously disinfected, was covered with a sterile sheath containing sterile coupling gel.
First, the transducer was positioned in a paramedian sagittal plane, placed 1-2 cm lateral to the spinous processes. The sacrum was identified as a flat, hyperechoic structure producing a marked acoustic shadow, serving as the starting landmark for identifying successive lumbar intervertebral spaces. By gradually sliding the transducer cephalad, the vertebral laminae appeared as hyperechoic lines alternating with their posterior acoustic shadows. The interlaminar spaces, located between two adjacent laminae, form true acoustic windows that allow visualization of the underlying neuraxial structures.
The exploration continued until the intervertebral space deemed optimal for puncture was identified. The probe was then switched to a midline posit Receives: Device: Ultrasound-guided spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
procedure time
Measured: 60sec
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Feb 2025
- Primary completion31 May 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound GuidanceStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Military Hospital of Tunis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, askrihaythem, Military Hospital of Tunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327801
- Sponsor's protocol ID
- 54/2024/clpp/militaryhosptunis
- Status last verified
- Dec 2025
- First submitted
- 25 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Ultrasound Guidance on the Performance of Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT07327801
- Acronym / sponsor ID
- 54/2024/clpp/militaryhosptunis
- Conditions
- Ultrasound Guidance, Spinal Anesthesia, Procedural Performance, Conventional Palpation Technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Military Hospital of TunisUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 8 Jan 2026 (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.
Neuraxial anesthesia is a commonly employed technique for subumbilical surgical procedures due to its effectiveness and safety profile. The advent of ultrasound technology has introduced the possibility of visualizing anatomical landmarks in real time, thereby facilitating more accurate and potentially safer subarachnoid punctures. This study aims to compare conventional spinal anesthesia, based on palpation, with ultrasound-guided spinal anesthesia, focusing on procedural ease and overall facilitation.
it's a prospective, single-center, randomized, single-blind study. We included patients aged 18 years or older, classified as ASA I or II, scheduled for elective surgery, and who provided written informed consent. Exclusion criteria included failed subarachnoid puncture, conversion to general anesthesia, or the occurrence of major intraoperative complications such as vasovagal episodes or cardiac rhythm disturbances. Participants were randomly assigned, based on a randomization table, into two groups: Group1 (traditional technique), in which spinal anesthesia was performed using the conventional palpation-based method for space localization; and Group2 (ultrasound-guided technique), in which spinal anesthesia was performed under real-time ultrasound guidance. The primary outcome was the total procedure time, measured in seconds from the end of skin antisepsis to the initiation of subarachnoid injection. Secondary outcomes included the number of puncture attempts, the number of needle redirections within the same interspace, the occurrence of procedural incidents, and postoperative complaints such as radicular pain, osseous contact pain, intraoperative paresthesias, and traumatic punctures.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional spinal anesthesia | Active comparator | Device: Conventional spinal anesthesiaThe operator began by palpating the posterior superior iliac spines to mentally determine the Tuffier's line, which roughly corresponds to the L4-L5 intervertebral space. The spinous processes were then palpated to precisely locate the targeted intervertebral space. The needle was subsequently inserted until cerebrospinal fluid return was obtained, and the anesthetic agent was administered slowly |
| Ultrasound-guided spinal anesthesia | Active comparator | Device: Ultrasound-guided spinal anesthesiaThe operator set up the sterile equipment, which included an ultrasound machine equipped with a low-frequency convex probe (2-5 MHz). The probe, previously disinfected, was covered with a sterile sheath containing sterile coupling gel. First, the transducer was positioned in a paramedian sagittal plane, placed 1-2 cm lateral to the spinous processes. The sacrum was identified as a flat, hyperechoic structure producing a marked acoustic shadow, serving as the starting landmark for identifying successive lumbar intervertebral spaces. By gradually sliding the transducer cephalad, the vertebral laminae appeared as hyperechoic lines alternating with their posterior acoustic shadows. The interlaminar spaces, located between two adjacent laminae, form true acoustic windows that allow visualization of the underlying neuraxial structures. The exploration continued until the intervertebral space deemed optimal for puncture was identified. The probe was then switched to a midline posit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 years or older.
- Classified as American Society of Anesthesiologists (ASA) physical status I or II.
- Scheduled for elective surgery under spinal anesthesia.
- Provided written informed consent.
Key exclusion criteria (3 listed)
- Failed subarachnoid puncture.
- Conversion to general anesthesia.
- Occurrence of major intraoperative complications (e.g., vasovagal episodes, cardiac rhythm disturbances).
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 |
|---|---|---|
| Conventional spinal anesthesiaThe spinous processes were then palpated to precisely locate the targeted intervertebral space | Device | Conventional spinal anesthesia |
| Ultrasound-guided spinal anesthesiaA combined sequence was used, beginning with a longitudinal paramedian scan, followed by a 90-degree rotation to obtain a transverse interspinous view. This allowed for the identification of the spinal canal, after which the puncture was performed using dynamic, out-of-plane guidance | Device | Ultrasound-guided spinal anesthesia |
Primary outcome
procedure time
Time frame: 60sec
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 8 Jan 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional spinal anesthesia and Ultrasound-guided spinal anesthesia in people with Ultrasound Guidance and Spinal Anesthesia, run by Military Hospital of Tunis at 1 site 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 4 inclusion and 3 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 8 Jan 2026. 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 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?
procedure time (time frame: 60sec). 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 8 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.