Lumbar UltrasoundNCT02553746

Ultrasound for Neuraxial Anesthesia

A study testing Detection of the puncture site by ultrasound scan of the lumbar spine. and Detection of the puncture site by identification of the landmarks. in people with Lumbar Ultrasound, run by 424 General Military Hospital at 1 site in Greece.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Lumbar Ultrasound
What is being tested?: Detection of the puncture site by ultrasound scan of the lumbar spine. and Detection of the puncture site by identification of the landmarks.
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 146 participants
Where: 1 siteGreece
Study dates: Sep 2015to 10 Jan 2018
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 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Surgery under spinal, epidural or combined spinal-epidural anesthesia.
Surgery under general anesthesia and preoperative placement of epidural catheter for postoperative analgesia.
ASA 1-3.

Who cannot join

History of lumbar spinal surgery.
Low back pain at the time of anesthesia

Trial locations and contacts

1 site in 1 country.

Greece1 site

424 Army General Hospital Department of Anesthesia
Thessaloniki, 56429

Other trials in Greece

About this study

Official title: Study of the Use of Ultrasound Scan for Lumbar Regional Anesthesia

The patients will be allocated to 2 groups: the ultrasound group and the palpation group. Ultrasound detection of the puncture site will be performed to the patients of the one group (group U). The puncture site will be determined by palpation of the landmarks at the patients of the other group (group L). The main purpose of the study is to determine if the ultrasound scan of the lumbar spine can facilitate spinal, epidural and combined spinal-epidural anesthesia, increase the success and decrease the complication rate of these techniques. The secondary purpose of the study is to evaluate if the lumbar ultrasound scan can be used to determine accurately the depth of the epidural space.

Conditions: Lumbar Ultrasound
Being tested: Detection of the puncture site by ultrasound scan of the lumbar spine., Detection of the puncture site by identification of the landmarks.
Keywords: Ultrasound, Spinal anesthesia, Epidural anesthesia

What participants receive

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

Detection of the puncture site by ultrasound scan of the lumbar spine.Device
Neuraxial anesthesia will be performed to the patients after detection of the puncture site by ultrasound scan of the spine. The scanning will be performed as described by Arzola et al. The L3-L4 space will be identified by palpation and identification of the landmarks (Tuffier's line). The ultrasound probe will be placed perpendicular to the long axis of the spine. The spinous process will be identified (bright signal followed by dark triangular area). The probe will be moved to cephalad or caudal to identify the intervertebral space and when the best view of the ligamentum flavum is achieved two marks will be drawn on the skin: one at the center of the upper surface of the probe and one at the center of the right lateral vertical side of the probe. The intersection of the two landmarks will be the puncture site. The distance from the skin to the ligamentum flavum will be measured by the ultrasound caliper.
Detection of the puncture site by identification of the landmarks.Procedure or surgery
Neuraxial anesthesia will be performed to the patients after detection of the puncture site by the identification of the landmarks. The L3-L4 space will be identified by palpation of the posterior iliac crests and the ideal intervertebral space will be selected after palpation of the spinous processes.

Study groups in NCT02553746
Study group	Role	What they receive
Ultrasound	Experimental	Not described Receives: Device: Detection of the puncture site by ultrasound scan of the lumbar spine.
Landmarks	Active comparator	Not described Receives: Procedure: Detection of the puncture site by identification of the landmarks.

What is being measured

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

Number of Participants With Successful Techniques
For spinal and epidural anesthesia, success of the technique is defined as the installation of sensory block before surgery. For epidural catheter placement success of the technique is defined as the installation of sensory block after the end of surgery.
Measured: An expected average of 10 minutes after the technique.
Number of Participants With Success of the Technique at the First Attempt
Number of patients with completion of the technique without any withdrawal or reposition of the needle.
Measured: An expected average of 10 minutes after the technique.
Number of Attempts Required.
How many times did the operator withdraw the needle and repeated the puncture.
Measured: An expected average of 10 minutes after the technique..
Repositioning Frequency.
How many times did the operator change the trajectory of the needle.
Measured: An expected average of 10 minutes after the technique.
Number of Participants With Change of the Intervertebral Space.
Number of patients to whom the operator had to perform the puncture at a different intervertebral place than the initial one.
Measured: An expected average of 10 minutes after the technique.
Time Required.
Time passed from the positioning of the patient on the table until the end of the neuraxial anesthesia
Measured: An expected average of 15 minutes.

Secondary outcomes (6)

Depth of the Epidural Space Measured by Ultrasound.
The distance between the skin and the ligamentum flavum measured by the built-in ultrasound caliper.
Measured: An expected average of 3 minutes after the beginning of the procedure.
Depth of the Epidural Space Measured by the Needle.
The distance between the skin and the ligamentum flavum measured by the markers on the Tuohy needle.
Measured: An expected average of 5 minutes after the beginning of the procedure.
Number of Patients With Low Back Pain.
Number of patients who reported low back pain after the technique.
Measured: 12hours and 24hours after the end of the technique.
Low Back Pain Intensity.
The patient is asked to evaluate the lumbar pain by the 11scale Numerical Rating Scale (0 no pain, 10 maximum possible pain).
Measured: 12hours and 24hours after the end of the technique.
Patient Satisfaction.
The patient is asked if he is satisfied with the technique (Definitely not, Not completely, Yes) and if he would choose the same technique in the future (Yes/No).
Measured: 12hours after the end of the technique.
Number of Participants With Any Complication.
Number of patients who had any complication after the technique
Measured: 24hours after the end of the technique.

Timeline

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

Sep 201510 Jan 2018

First posted18 Sep 2015 (estimated)
Study startSep 2015
Primary completion10 Jan 2018
Study completion10 Jan 2018

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 (32)Papers the sponsor has linked to this study.
Other trials for Lumbar UltrasoundStudies 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 146 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02553746
Sponsor's protocol ID: 14073
Status last verified: Jul 2019
First submitted: 15 Sep 2015
Last updated: 12 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Ali ME, Laurito CE. Ultrasound guidance for epidural catheter placement: a coming of age? J Clin Anesth. 2005 May;17(3):235-6. doi: 10.1016/j.jclinane.2005.02.002. No abstract available.
PubMed 15896595
Arzola C, Davies S, Rofaeel A, Carvalho JC. Ultrasound using the transverse approach to the lumbar spine provides reliable landmarks for labor epidurals. Anesth Analg. 2007 May;104(5):1188-92, tables of contents. doi: 10.1213/01.ane.0000250912.66057.41.
PubMed 17456672
Arzola C, Mikhael R, Margarido C, Carvalho JC. Spinal ultrasound versus palpation for epidural catheter insertion in labour: A randomised controlled trial. Eur J Anaesthesiol. 2015 Jul;32(7):499-505. doi: 10.1097/EJA.0000000000000119.
PubMed 25036283
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
Balki M, Lee Y, Halpern S, Carvalho JC. Ultrasound imaging of the lumbar spine in the transverse plane: the correlation between estimated and actual depth to the epidural space in obese parturients. Anesth Analg. 2009 Jun;108(6):1876-81. doi: 10.1213/ane.0b013e3181a323f6.
PubMed 19448216
Darrieutort-Laffite C, Bart G, Planche L, Glemarec J, Maugars Y, Le Goff B. Usefulness of a pre-procedure ultrasound scanning of the lumbar spine before epidural injection in patients with a presumed difficult puncture: A randomized controlled trial. Joint Bone Spine. 2015 Oct;82(5):356-61. doi: 10.1016/j.jbspin.2015.02.001. Epub 2015 Mar 9.
PubMed 25764916
Grau T, Leipold RW, Conradi R, Martin E. Ultrasound control for presumed difficult epidural puncture. Acta Anaesthesiol Scand. 2001 Jul;45(6):766-71. doi: 10.1034/j.1399-6576.2001.045006766.x.
PubMed 11421838
Grau T, Leipold RW, Conradi R, Martin E, Motsch J. Ultrasound imaging facilitates localization of the epidural space during combined spinal and epidural anesthesia. Reg Anesth Pain Med. 2001 Jan-Feb;26(1):64-7. doi: 10.1053/rapm.2001.19633. No abstract available.
PubMed 11172514
Grau T, Leipold RW, Delorme S, Martin E, Motsch J. Ultrasound imaging of the thoracic epidural space. Reg Anesth Pain Med. 2002 Mar-Apr;27(2):200-6. doi: 10.1053/rapm.2002.29239.
PubMed 11915069
Grau T, Leipold RW, Fatehi S, Martin E, Motsch J. Real-time ultrasonic observation of combined spinal-epidural anaesthesia. Eur J Anaesthesiol. 2004 Jan;21(1):25-31. doi: 10.1017/s026502150400105x.
PubMed 14768920
Grau T, Leipold RW, Horter J, Conradi R, Martin EO, Motsch J. Paramedian access to the epidural space: the optimum window for ultrasound imaging. J Clin Anesth. 2001 May;13(3):213-7. doi: 10.1016/s0952-8180(01)00245-8.
PubMed 11377160
Grau T, Bartusseck E, Conradi R, Martin E, Motsch J. Ultrasound imaging improves learning curves in obstetric epidural anesthesia: a preliminary study. Can J Anaesth. 2003 Dec;50(10):1047-50. doi: 10.1007/BF03018371.
PubMed 14656785
Grau T, Leipold RW, Conradi R, Martin E, Motsch J. Efficacy of ultrasound imaging in obstetric epidural anesthesia. J Clin Anesth. 2002 May;14(3):169-75. doi: 10.1016/s0952-8180(01)00378-6.
PubMed 12031746
Helayel PE, da Conceicao DB, Meurer G, Swarovsky C, de Oliveira Filho GR. Evaluating the depth of the epidural space with the use of ultrasound. Rev Bras Anestesiol. 2010 Jul-Aug;60(4):376-82. doi: 10.1016/S0034-7094(10)70046-5. English, Portuguese.
PubMed 20659609
Hotta K. [Ultrasound-guided epidural block]. Masui. 2008 May;57(5):556-63. Japanese.
PubMed 18516882

Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of the Use of Ultrasound Scan for Lumbar Regional Anesthesia
ClinicalTrials.gov ID: NCT02553746
Acronym / sponsor ID: 14073
Conditions: Lumbar Ultrasound
Keywords: Ultrasound, Spinal anesthesia, Epidural anesthesia
Study type: Interventional
Recruitment status: Completed
Enrolment: 146 participants (actual)
Lead sponsor: 424 General Military HospitalUniversity, hospital or other
Study start: Sep 2015
Primary completion: 10 Jan 2018 (actual)
Study completion: 10 Jan 2018 (actual)
First posted: 18 Sep 2015 (estimated)
Results: Posted 12 Aug 2019

Clinical summary

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

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Ultrasound	Experimental	Device: Detection of the puncture site by ultrasound scan of the lumbar spine.
Landmarks	Active comparator	Procedure: Detection of the puncture site by identification of the landmarks.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Surgery under spinal, epidural or combined spinal-epidural anesthesia.
Surgery under general anesthesia and preoperative placement of epidural catheter for postoperative analgesia.
ASA 1-3.

Key exclusion criteria (2 listed)

History of lumbar spinal surgery.
Low back pain at the time of 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
Detection of the puncture site by ultrasound scan of the lumbar spine.Neuraxial anesthesia will be performed to the patients after detection of the puncture site by ultrasound scan of the spine. The scanning will be performed as described by Arzola et al. The L3-L4 space will be identified by palpation and identification of the landmarks (Tuffier's line). The ultrasound probe will be placed perpendicular to the long axis of the spine. The spinous process will be identified (bright signal followed by dark triangular area). The probe will be moved to cephalad or caudal to identify the intervertebral space and when the best view of the ligamentum flavum is achieved two marks will be drawn on the skin: one at the center of the upper surface of the probe and one at the center of the right lateral vertical side of the probe. The intersection of the two landmarks will be the puncture site. The distance from the skin to the ligamentum flavum will be measured by the ultrasound caliper.	Device	Ultrasound
Detection of the puncture site by identification of the landmarks.Neuraxial anesthesia will be performed to the patients after detection of the puncture site by the identification of the landmarks. The L3-L4 space will be identified by palpation of the posterior iliac crests and the ideal intervertebral space will be selected after palpation of the spinous processes.	Procedure or surgery	Landmarks

Primary outcome

Number of Participants With Successful Techniques
Time frame: An expected average of 10 minutes after the technique.
For spinal and epidural anesthesia, success of the technique is defined as the installation of sensory block before surgery. For epidural catheter placement success of the technique is defined as the installation of sensory block after the end of surgery.
Number of Participants With Success of the Technique at the First Attempt
Time frame: An expected average of 10 minutes after the technique.
Number of patients with completion of the technique without any withdrawal or reposition of the needle.
Number of Attempts Required.
Time frame: An expected average of 10 minutes after the technique..
How many times did the operator withdraw the needle and repeated the puncture.
Repositioning Frequency.
Time frame: An expected average of 10 minutes after the technique.
How many times did the operator change the trajectory of the needle.
Number of Participants With Change of the Intervertebral Space.
Time frame: An expected average of 10 minutes after the technique.
Number of patients to whom the operator had to perform the puncture at a different intervertebral place than the initial one.
Time Required.
Time frame: An expected average of 15 minutes.
Time passed from the positioning of the patient on the table until the end of the neuraxial anesthesia

6 secondary outcomes

Depth of the Epidural Space Measured by Ultrasound.
Time frame: An expected average of 3 minutes after the beginning of the procedure.
Depth of the Epidural Space Measured by the Needle.
Time frame: An expected average of 5 minutes after the beginning of the procedure.
Number of Patients With Low Back Pain.
Time frame: 12hours and 24hours after the end of the technique.
Low Back Pain Intensity.
Time frame: 12hours and 24hours after the end of the technique.
Patient Satisfaction.
Time frame: 12hours after the end of the technique.
Number of Participants With Any Complication.
Time frame: 24hours after the end of the technique.

Results and safety

Results posted to the registry on 12 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ultrasound	80	77
Landmarks	66	64

Primary outcome: Number of Participants With Successful Techniques

Time frame: An expected average of 10 minutes after the technique.. Count of participants. Unit: Participants

Measure	Ultrasound n = 77	Landmarks n = 64
Value	74	63

Ultrasound vs Landmarks: p = 0.748, Chi-squared, Corrected

Primary outcome: Number of Participants With Success of the Technique at the First Attempt

Time frame: An expected average of 10 minutes after the technique.. Count of participants. Unit: Participants

Measure	Ultrasound n = 77	Landmarks n = 64
Value	48	35

Ultrasound vs Landmarks: p = 0.498, Chi-squared, Corrected

Primary outcome: Number of Attempts Required.

Time frame: An expected average of 10 minutes after the technique... Mean (Standard Deviation). Unit: number of attempts

Measure	Ultrasound n = 77	Landmarks n = 64
Value	1.65 (0.978)	2.06 (1.413)

Ultrasound vs Landmarks: p = 0.171, Wilcoxon (Mann-Whitney)

Primary outcome: Repositioning Frequency.

Time frame: An expected average of 10 minutes after the technique.. Mean (Standard Deviation). Unit: repositioning attempts

Measure	Ultrasound n = 77	Landmarks n = 64
Value	0.74 (0.973)	1.14 (1.357)

Ultrasound vs Landmarks: p = 0.162, Wilcoxon (Mann-Whitney)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Within 24 hours after the completion of the technique. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ultrasound	0 of 80 (0%)	80 of 80 (100%)	0 of 80
Landmarks	0 of 66 (0%)	66 of 66 (100%)	0 of 66

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 15896595Ali ME, Laurito CE. Ultrasound guidance for epidural catheter placement: a coming of age? J Clin Anesth. 2005 May;17(3):235-6. doi: 10.1016/j.jclinane.2005.02.002. No abstract available.
Background: PubMed 17456672Arzola C, Davies S, Rofaeel A, Carvalho JC. Ultrasound using the transverse approach to the lumbar spine provides reliable landmarks for labor epidurals. Anesth Analg. 2007 May;104(5):1188-92, tables of contents. doi: 10.1213/01.ane.0000250912.66057.41.
Background: PubMed 25036283Arzola C, Mikhael R, Margarido C, Carvalho JC. Spinal ultrasound versus palpation for epidural catheter insertion in labour: A randomised controlled trial. Eur J Anaesthesiol. 2015 Jul;32(7):499-505. doi: 10.1097/EJA.0000000000000119.
Background: 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.
Background: PubMed 19448216Balki M, Lee Y, Halpern S, Carvalho JC. Ultrasound imaging of the lumbar spine in the transverse plane: the correlation between estimated and actual depth to the epidural space in obese parturients. Anesth Analg. 2009 Jun;108(6):1876-81. doi: 10.1213/ane.0b013e3181a323f6.
Background: PubMed 25764916Darrieutort-Laffite C, Bart G, Planche L, Glemarec J, Maugars Y, Le Goff B. Usefulness of a pre-procedure ultrasound scanning of the lumbar spine before epidural injection in patients with a presumed difficult puncture: A randomized controlled trial. Joint Bone Spine. 2015 Oct;82(5):356-61. doi: 10.1016/j.jbspin.2015.02.001. Epub 2015 Mar 9.
Background: PubMed 11421838Grau T, Leipold RW, Conradi R, Martin E. Ultrasound control for presumed difficult epidural puncture. Acta Anaesthesiol Scand. 2001 Jul;45(6):766-71. doi: 10.1034/j.1399-6576.2001.045006766.x.
Background: PubMed 11172514Grau T, Leipold RW, Conradi R, Martin E, Motsch J. Ultrasound imaging facilitates localization of the epidural space during combined spinal and epidural anesthesia. Reg Anesth Pain Med. 2001 Jan-Feb;26(1):64-7. doi: 10.1053/rapm.2001.19633. No abstract available.
Background: PubMed 11915069Grau T, Leipold RW, Delorme S, Martin E, Motsch J. Ultrasound imaging of the thoracic epidural space. Reg Anesth Pain Med. 2002 Mar-Apr;27(2):200-6. doi: 10.1053/rapm.2002.29239.
Background: PubMed 14768920Grau T, Leipold RW, Fatehi S, Martin E, Motsch J. Real-time ultrasonic observation of combined spinal-epidural anaesthesia. Eur J Anaesthesiol. 2004 Jan;21(1):25-31. doi: 10.1017/s026502150400105x.
Background: PubMed 11377160Grau T, Leipold RW, Horter J, Conradi R, Martin EO, Motsch J. Paramedian access to the epidural space: the optimum window for ultrasound imaging. J Clin Anesth. 2001 May;13(3):213-7. doi: 10.1016/s0952-8180(01)00245-8.
Background: PubMed 14656785Grau T, Bartusseck E, Conradi R, Martin E, Motsch J. Ultrasound imaging improves learning curves in obstetric epidural anesthesia: a preliminary study. Can J Anaesth. 2003 Dec;50(10):1047-50. doi: 10.1007/BF03018371.

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.

Georgios Kotsovolis principal investigator

424 Army General Hospital of Thessaloniki

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 2 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 12 Aug 2019. 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 Greece. 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 12 Aug 2019). 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 Participants With Successful Techniques (time frame: An expected average of 10 minutes after the technique.). The study lists 6 primary outcomes in all. 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 NCT02553746, which also lists 32 linked publications.

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 12 Aug 2019; AzTrials last refreshed its copy on 6 Nov 2026.