Spinal AnesthesiaNCT06740994
Ultrasound Guided Midline vs Landmark Paramedian Continous Spinal Anesthesia in the Elderly
A study testing conventional landmark paramedian technique and preprocedural ultrasound guided midline technique in people with Spinal Anesthesia, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
Former clinical studies have reported the superiority of the landmark guided paramedian approach above the classical landmark guided midline approach for the continuous spinal anesthesia especially in the elderly. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Spinal Anesthesia
- What is being tested?
- conventional landmark paramedian technique and preprocedural ultrasound guided midline technique
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTunisia
- Study dates
- 29 Apr 2024to 30 Jun 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- all consented patients aged over 65 years old scheduled to undergo surgery for hip fracture under continuous spinal anesthesia with American Society of Anesthesiologists ASA physical status classification from I to III
Who cannot join
- contraindications to spinal anesthesia ( allergy to local anesthetic, coagulopathy, infection at the site of injection)
- previous history of lumbar spine surgery
- per operative severe complication with conversion to general anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Midline Continuous Spinal Anesthesia in the Elderly : is There an Advantage Over Conventional Landmark Paramedian Technique: a Randomized Controlled Trial
Former clinical studies have reported the superiority of the landmark guided paramedian approach above the classical landmark guided midline approach for the continuous spinal anesthesia especially in the elderly. On the other hand, more recent clinical trials have suggested that the use of ultrasound to guide spinal anesthesia will be safer and more effective than the conventional palpation-guided technique.
The aim of this study will be to compare the conventional "blind" landmark paramedian approach to the ultrasound "modern" guided midline approach for the continuous spinal anesthesia in the elderly with hip fractures.
Read more
Patients will randomly divided into two groups:
Group(PML): will undergo conventional landmark guided paramedian continuous spinal anesthesia Group (MUS): will undergo ultrasound guided midline continuous spinal anesthesia
Read the detailed description
All elderly patients above 65 years old scheduled for elective surgery for hip fracture under continuous spinal anesthesia will be included in the study.
Patients will randomly divided into two groups by using random number generating software (Research Randomizer Version 4.0) Group(PML): will undergo conventional landmark guided paramedian continuous spinal anesthesia Group(MUS) : will undergo ultrasound guided midline continuous spinal anesthesia A written informed consent will be obtained from all participants, who will be blinded as to their allocated group.
After establishing a baseline monitoring (3 lead ECG, pulse oximetry and non-invasive blood pressure) and an intravenous access, a fascia-iliaca ultrasound guided block at the fractured hip will be performed for all patients by the injection of 20 ml of 1.5 % lidocaine.
15 minutes later with the aid of an assistant, the patient will be positioned at the edge of the operating table in an arched back posture.
In both groups the continuous spinal anesthesia(CSA) will be performed with one of three anesthesiologists (two residents in their fourth year of training anesthesia and one associate professor), each have sufficient experience in performing neuraxial ultrasound scans prior to the study. To fulfill this they will use an 18 gauge Tuohy needle with a 22 gauge intrathecal catheter.
In group PML:
The anesthesiologist will star by drawing the 10th rib line then he will by palpation identify the most prominent spinous process beneath. At this level he will mark on the patient skin the point of injection which will be1 cm lateral and 1 cm caudal to the caudal edge of the spinous process chosen.
After infiltration of the skin with 3 ml of 1% lidocaine at the marked site, the anesthesiologist will introduce the tuohy needle in a cephalomedial direction 10 to 15° off the sagittal plane.
when cerebrospinal fluid will be obtained, the CSA (continuous spinal anesthesia) catheter will be advanced 3 cm cephalad to the intrathecal space and taped to the skin.
The patient will be then returned to dorsal position and a volume of 30 ug of fentanyl and 3 ml of 0.1% isobar bupivacaine will be injected intrathecally via the catheter.
The intervertebral level at which the injection will be done,will be scanned with ultrasound at the end of the surgery, before CSA catheter withdrawal.
In group MUS:
The anesthesiologist will use a portable ultrasonography with a curved 2-5 MHz (Mega Hertz) probe to detect the sacrum in the paramedian sagittal oblique view (PSO) of the neuroaxis.
Than the transducer will be moved cephalad to scan the quality of interspinous spaces from L5/S1 to L2/L3. The interlaminar space that will have the best PSO quality i.e the clearest and largest ultrasound image of the posterior complex ( ligamentum flavum and posterior dura) and anterior complex ( posterior longitudinal ligament and anterior dura) will be chosen as the interspace for injection.
At this level a skin marker will be used to mark the midpoint of the short borders of the probe. Following this the probe will be rotated by 90° to obtain the transverse median view (TM) and by the same way the midpoint of the short borders of the probe will be marked.
The intersection of these two marks will be used as the point of injection. Similarly skin will be infiltrated with lidocaine and the tuohy needle will be inserted in the cephalomedial plane with a cephalad angle estimated by the probe inclination in the TM view.In this group, the anesthesiologist will not palpate the landmarks except he changing technique.For the rest of the procedure, the same steps will be followed.
In both groups, an alternative technique would be used if unsuccessful after 3 attempts( landmark/ultrasound guided paramedian approach for MUS Group ; landmark/ultrasound midline approach for PML Group).
For all participants strict asepsis will be respected throughout all the procedure, The distance needed to reach the intrathecal space from the skin will be recorded and the quality of the interspinous spaces chosen will be noted in the PSO and TM ultrasound views using a predefined scale (good = both posterior and anterior complex visible ; intermediate = posterior or anterior complex visible ; poor = neither complex visible)
- Conditions
- Spinal Anesthesia
- Being tested
- conventional landmark paramedian technique, preprocedural ultrasound guided midline technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional landmark paramedian techniqueProcedure or surgery
Also called PML
a blind landmark scanning will be done and skin marking of the best palpable spinous process will be made.
the site of injection will be determined by palpation. continuous spinal anesthesia will be performed via paramedian approach.
preprocedural ultrasound guided midline techniqueProcedure or surgery
Also called MUS
a preprocedural ultrasound scanning will be done, and skin marking of the best quality space will be made.
the site of injection and the insertion angle of the needle will be determined by ultrasound.
continuous spinal anesthesia will be performed via midline approach.
| Study group | Role | What they receive |
|---|---|---|
| paramedian landmark group | Experimental | conventional landmark paramedian approach will be performed. isobar bupivacaine will be injected for continuous spinal anesthesia. Receives: Procedure: conventional landmark paramedian technique |
| Midline ultrasound group | Active comparator | preprocedural ultrasound guided midline approach will be performed. isobar bupivacaine will be injected for continuous spinal anesthesia. Receives: Procedure: preprocedural ultrasound guided midline technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
the difference in number of needle passes between the two groups
the number of forward advancements of the Tuohy needle in a given interspinous space (i.e withdrawal and redirection of Tuohy needle without exiting the skin)
Measured: from the first insertion of the needle until the fixation of the continuous spinal anesthesia catheter to patient skin
Secondary outcomes (6)
number of spinal needle insertion attempts
the number of times the tuohy needle was withdrawn from the skin and reinserted
Measured: from the first insertion of the needle until the fixation of the continuous spinal anesthesia catheter to patient skin
the rate of first pass success
a single needle insertion with no redirection
Measured: from the first insertion of the needle until the fixation of the continuous spinal anesthesia catheter to patient skin
time for identifying landmarks
in group PML: time from which the anesthesiologist started palpating to identify the landmarks to the needle entry point marking in group MUS: time from which the ultrasound probe was placed on the skin to the needle entry point marking
Measured: time taken from start of palpating or ultrasound scanning to the marking of the needle entry point
time taken for performing continuous spinal anesthesia
time from first needle insertion to fixation of continuous spinal anesthesia catheter to patient skin
Measured: time taken from the start of the first insertion of the needle to the completion of fixation of the catheter to patient skin
incidence of continuous spinal anesthesia complications
defined as: incidence of radicular pain, parasthesia and blood in the Tuohy needle
Measured: from the star of first needle insertion to the completion of the continuous spinal anesthesia
the injection level
the interspinous level at which dural puncture was done
Measured: from the start of identifying landmarks until the patient leaves the operation room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start29 Apr 2024
- Primary completion29 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies 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
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Ben Ahmed, University Tunis El Manar
- Investigators
- MECHAAL BEN ALI, Professor, Principal investigator, university manar Tunis, Tunisia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740994
- Sponsor's protocol ID
- UTEM USSA
- Status last verified
- Aug 2026
- First submitted
- 14 Dec 2024
- Last updated
- 19 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Midline Continuous Spinal Anesthesia in the Elderly : is There an Advantage Over Conventional Landmark Paramedian Technique: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06740994
- Acronym / sponsor ID
- UTEM USSA
- Conditions
- Spinal Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 29 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 18 Dec 2024 (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.
Former clinical studies have reported the superiority of the landmark guided paramedian approach above the classical landmark guided midline approach for the continuous spinal anesthesia especially in the elderly. On the other hand, more recent clinical trials have suggested that the use of ultrasound to guide spinal anesthesia will be safer and more effective than the conventional palpation-guided technique.
The aim of this study will be to compare the conventional "blind" landmark paramedian approach to the ultrasound "modern" guided midline approach for the continuous spinal anesthesia in the elderly with hip fractures.
Patients will randomly divided into two groups:
Group(PML): will undergo conventional landmark guided paramedian continuous spinal anesthesia Group (MUS): will undergo ultrasound guided midline continuous spinal anesthesia
Detailed description
All elderly patients above 65 years old scheduled for elective surgery for hip fracture under continuous spinal anesthesia will be included in the study.
Patients will randomly divided into two groups by using random number generating software (Research Randomizer Version 4.0) Group(PML): will undergo conventional landmark guided paramedian continuous spinal anesthesia Group(MUS) : will undergo ultrasound guided midline continuous spinal anesthesia A written informed consent will be obtained from all participants, who will be blinded as to their allocated group.
After establishing a baseline monitoring (3 lead ECG, pulse oximetry and non-invasive blood pressure) and an intravenous access, a fascia-iliaca ultrasound guided block at the fractured hip will be performed for all patients by the injection of 20 ml of 1.5 % lidocaine.
15 minutes later with the aid of an assistant, the patient will be positioned at the edge of the operating table in an arched back posture.
In both groups the continuous spinal anesthesia(CSA) will be performed with one of three anesthesiologists (two residents in their fourth year of training anesthesia and one associate professor), each have sufficient experience in performing neuraxial ultrasound scans prior to the study. To fulfill this they will use an 18 gauge Tuohy needle with a 22 gauge intrathecal catheter.
In group PML:
The anesthesiologist will star by drawing the 10th rib line then he will by palpation identify the most prominent spinous process beneath. At this level he will mark on the patient skin the point of injection which will be1 cm lateral and 1 cm caudal to the caudal edge of the spinous process chosen.
After infiltration of the skin with 3 ml of 1% lidocaine at the marked site, the anesthesiologist will introduce the tuohy needle in a cephalomedial direction 10 to 15° off the sagittal plane.
when cerebrospinal fluid will be obtained, the CSA (continuous spinal anesthesia) catheter will be advanced 3 cm cephalad to the intrathecal space and taped to the skin.
The patient will be then returned to dorsal position and a volume of 30 ug of fentanyl and 3 ml of 0.1% isobar bupivacaine will be injected intrathecally via the catheter.
The intervertebral level at which the injection will be done,will be scanned with ultrasound at the end of the surgery, before CSA catheter withdrawal.
In group MUS:
The anesthesiologist will use a portable ultrasonography with a curved 2-5 MHz (Mega Hertz) probe to detect the sacrum in the paramedian sagittal oblique view (PSO) of the neuroaxis.
Than the transducer will be moved cephalad to scan the quality of interspinous spaces from L5/S1 to L2/L3. The interlaminar space that will have the best PSO quality i.e the clearest and largest ultrasound image of the posterior complex ( ligamentum flavum and posterior dura) and anterior complex ( posterior longitudinal ligament and anterior dura) will be chosen as the interspace for injection.
At this level a skin marker will be used to mark the midpoint of the short borders of the probe. Following this the probe will be rotated by 90° to obtain the transverse median view (TM) and by the same way the midpoint of the short borders of the probe will be marked.
The intersection of these two marks will be used as the point of injection. Similarly skin will be infiltrated with lidocaine and the tuohy needle will be inserted in the cephalomedial plane with a cephalad angle estimated by the probe inclination in the TM view.In this group, the anesthesiologist will not palpate the landmarks except he changing technique.For the rest of the procedure, the same steps will be followed.
In both groups, an alternative technique would be used if unsuccessful after 3 attempts( landmark/ultrasound guided paramedian approach for MUS Group ; landmark/ultrasound midline approach for PML Group).
For all participants strict asepsis will be respected throughout all the procedure, The distance needed to reach the intrathecal space from the skin will be recorded and the quality of the interspinous spaces chosen will be noted in the PSO and TM ultrasound views using a predefined scale (good = both posterior and anterior complex visible ; intermediate = posterior or anterior complex visible ; poor = neither complex visible)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paramedian landmark group | Experimental | Procedure: conventional landmark paramedian techniqueconventional landmark paramedian approach will be performed. isobar bupivacaine will be injected for continuous spinal anesthesia. |
| Midline ultrasound group | Active comparator | Procedure: preprocedural ultrasound guided midline techniquepreprocedural ultrasound guided midline approach will be performed. isobar bupivacaine will be injected for continuous spinal anesthesia. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- all consented patients aged over 65 years old scheduled to undergo surgery for hip fracture under continuous spinal anesthesia with American Society of Anesthesiologists ASA physical status classification from I to III
Key exclusion criteria (3 listed)
- contraindications to spinal anesthesia ( allergy to local anesthetic, coagulopathy, infection at the site of injection)
- previous history of lumbar spine surgery
- per operative severe complication with conversion to general anesthesia
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 landmark paramedian techniqueAlso: PMLa blind landmark scanning will be done and skin marking of the best palpable spinous process will be made. the site of injection will be determined by palpation. continuous spinal anesthesia will be performed via paramedian approach. | Procedure or surgery | paramedian landmark group |
| preprocedural ultrasound guided midline techniqueAlso: MUSa preprocedural ultrasound scanning will be done, and skin marking of the best quality space will be made. the site of injection and the insertion angle of the needle will be determined by ultrasound. continuous spinal anesthesia will be performed via midline approach. | Procedure or surgery | Midline ultrasound group |
Primary outcome
the difference in number of needle passes between the two groups
Time frame: from the first insertion of the needle until the fixation of the continuous spinal anesthesia catheter to patient skin
the number of forward advancements of the Tuohy needle in a given interspinous space (i.e withdrawal and redirection of Tuohy needle without exiting the skin)
6 secondary outcomes
number of spinal needle insertion attempts
Time frame: from the first insertion of the needle until the fixation of the continuous spinal anesthesia catheter to patient skin
the rate of first pass success
Time frame: from the first insertion of the needle until the fixation of the continuous spinal anesthesia catheter to patient skin
time for identifying landmarks
Time frame: time taken from start of palpating or ultrasound scanning to the marking of the needle entry point
time taken for performing continuous spinal anesthesia
Time frame: time taken from the start of the first insertion of the needle to the completion of fixation of the catheter to patient skin
incidence of continuous spinal anesthesia complications
Time frame: from the star of first needle insertion to the completion of the continuous spinal anesthesia
the injection level
Time frame: from the start of identifying landmarks until the patient leaves the operation room
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 19 Aug 2026.
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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.
MECHAAL BEN ALI, Professor principal investigator
university manar Tunis, Tunisia
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 landmark paramedian technique and preprocedural ultrasound guided midline technique in people with Spinal Anesthesia, run by University Tunis El Manar 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 1 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 19 Aug 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?
the difference in number of needle passes between the two groups (time frame: from the first insertion of the needle until the fixation of the continuous spinal anesthesia catheter to patient skin). 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 19 Aug 2026.