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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound | Experimental |
| |
| Landmarks | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | An expected average of 10 minutes after the technique.. |
| Repositioning Frequency. | How many times did the operator change the trajectory of the needle. | 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. | 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 | An expected average of 15 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Depth of the Epidural Space Measured by Ultrasound. | The distance between the skin and the ligamentum flavum measured by the built-in ultrasound caliper. | An expected average of 3 minutes after the beginning of the procedure. |
| Depth of the Epidural Space Measured by the Needle. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Georgios Kotsovolis | 424 Army General Hospital of Thessaloniki | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 424 Army General Hospital Department of Anesthesia | Thessaloniki | 56429 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15896595 | Background | 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. | |
| 17456672 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ultrasound | 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 L3-L4 space will be identified by palpation and identification of the Tuffier's line. The ultrasound probe will be placed perpendicular to the long axis of the spine. The spinous process will be identified. 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. |
| FG001 | Landmarks | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ultrasound | 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 L3-L4 space will be identified by palpation and identification of the Tuffier's line. The ultrasound probe will be placed perpendicular to the long axis of the spine. The spinous process will be identified. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | An expected average of 10 minutes after the technique. |
|
Within 24 hours after the completion of the technique
The intervention of the study consists of ultrasound imaging which doesn't carry any risk for serious adverse events nor it can potentially affect all-cause mortality
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ultrasound | 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 L3-L4 space will be identified by palpation and identification of the Tuffier's line. The ultrasound probe will be placed perpendicular to the long axis of the spine. The spinous process will be identified. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Georgios Kotsovolis | 424 Army General Hospital | +306948182743 | gskotsos@gmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 10, 2015 | Mar 30, 2019 | Prot_SAP_000.pdf |
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|
| Detection of the puncture site by identification of the landmarks. | Procedure | 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. |
|
The distance between the skin and the ligamentum flavum measured by the markers on the Tuohy needle. |
| 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. | 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). | 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). | 12hours after the end of the technique. |
| Number of Participants With Any Complication. | Number of patients who had any complication after the technique | 24hours after the end of the technique. |
| 25036283 | Background | 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. |
| 21063818 | Background | 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. |
| 19448216 | Background | 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. |
| 25764916 | Background | 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. |
| 11421838 | Background | 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. |
| 11172514 | Background | 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. |
| 11915069 | Background | 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. |
| 14768920 | Background | 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. |
| 11377160 | Background | 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. |
| 14656785 | Background | 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. |
| 12031746 | Background | 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. |
| 20659609 | Background | 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. |
| 18516882 | Background | Hotta K. [Ultrasound-guided epidural block]. Masui. 2008 May;57(5):556-63. Japanese. |
| 19398454 | Background | Karmakar MK, Li X, Ho AM, Kwok WH, Chui PT. Real-time ultrasound-guided paramedian epidural access: evaluation of a novel in-plane technique. Br J Anaesth. 2009 Jun;102(6):845-54. doi: 10.1093/bja/aep079. Epub 2009 Apr 27. |
| 19258988 | Background | Liu SS, Ngeow JE, Yadeau JT. Ultrasound-guided regional anesthesia and analgesia: a qualitative systematic review. Reg Anesth Pain Med. 2009 Jan-Feb;34(1):47-59. doi: 10.1097/AAP.0b013e3181933ec3. |
| 25999759 | Background | Luo L, Ni J, Wu L, Luo D. Ultrasound-guided epidural anesthesia for a parturient with severe malformations of the skeletal system undergoing cesarean delivery: a case report. Local Reg Anesth. 2015 May 6;8:7-10. doi: 10.2147/LRA.S81696. eCollection 2015. |
| 25348834 | Background | Nassar M, Abdelazim IA. Pre-puncture ultrasound guided epidural insertion before vaginal delivery. J Clin Monit Comput. 2015 Oct;29(5):573-7. doi: 10.1007/s10877-014-9634-y. Epub 2014 Oct 28. |
| 16527803 | Background | Peng PW, Rofaeel A. Using ultrasound in a case of difficult epidural needle placement. Can J Anaesth. 2006 Mar;53(3):325-6. doi: 10.1007/BF03022227. No abstract available. |
| 25493689 | Background | Perlas A, Chaparro LE, Chin KJ. Lumbar Neuraxial Ultrasound for Spinal and Epidural Anesthesia: A Systematic Review and Meta-Analysis. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):251-60. doi: 10.1097/AAP.0000000000000184. |
| 25612990 | Background | Piosik ZM, Helbo-Hansen S, Sprehn M. [Ultrasound-guided performance of labour epidural analgesia in a patient with thoracolumbar scoliosis]. Ugeskr Laeger. 2015 Jan 26;177(2A):102-3. Danish. |
| 21698508 | Background | Rasoulian A, Lohser J, Najafi M, Rafii-Tari H, Tran D, Kamani AA, Lessoway VA, Abolmaesumi P, Rohling RN. Utility of prepuncture ultrasound for localization of the thoracic epidural space. Can J Anaesth. 2011 Sep;58(9):815-23. doi: 10.1007/s12630-011-9548-9. Epub 2011 Jun 23. |
| 18211995 | Background | Schlotterbeck H, Schaeffer R, Dow WA, Touret Y, Bailey S, Diemunsch P. Ultrasonographic control of the puncture level for lumbar neuraxial block in obstetric anaesthesia. Br J Anaesth. 2008 Feb;100(2):230-4. doi: 10.1093/bja/aem371. |
| 23532866 | Background | Shaikh F, Brzezinski J, Alexander S, Arzola C, Carvalho JC, Beyene J, Sung L. Ultrasound imaging for lumbar punctures and epidural catheterisations: systematic review and meta-analysis. BMJ. 2013 Mar 26;346:f1720. doi: 10.1136/bmj.f1720. |
| 23983645 | Background | Singh S, Wirth KM, Phelps AL, Badve MH, Shah TH, Sah N, Vallejo MC. Epidural catheter placement in morbidly obese parturients with the use of an epidural depth equation prior to ultrasound visualization. ScientificWorldJournal. 2013 Jul 25;2013:695209. doi: 10.1155/2013/695209. eCollection 2013. |
| 23546640 | Background | Taninishi H, Kawano K, Morita K. Ultrasound-assisted epidural anesthesia to amyotrophic woman. J Anesth. 2013 Oct;27(5):797-8. doi: 10.1007/s00540-013-1600-1. Epub 2013 Apr 2. No abstract available. |
| 23180059 | Background | Vaghadia H, Germain G, Tang R. Epidural analgesia in parturients with ankylosing spondylitis: a role for ultrasound surveillance and ultrasound-guided placement. Can J Anaesth. 2013 Feb;60(2):206. doi: 10.1007/s12630-012-9822-5. Epub 2012 Nov 22. No abstract available. |
| 20696564 | Background | Vallejo MC, Phelps AL, Singh S, Orebaugh SL, Sah N. Ultrasound decreases the failed labor epidural rate in resident trainees. Int J Obstet Anesth. 2010 Oct;19(4):373-8. doi: 10.1016/j.ijoa.2010.04.002. Epub 2010 Aug 8. |
| 23106885 | Background | Wang Q, Yin C, Wang TL. Ultrasound facilitates identification of combined spinal-epidural puncture in obese parturients. Chin Med J (Engl). 2012 Nov;125(21):3840-3. |
| 23473550 | Background | Wight JM, Male D, Combeer A. Ultrasound-guided combined spinal-epidural anaesthesia for elective caesarean section in a patient with achondroplasia. Int J Obstet Anesth. 2013 Apr;22(2):168-9. doi: 10.1016/j.ijoa.2013.01.007. Epub 2013 Mar 7. No abstract available. |
| 21800673 | Background | Yamashita J, Yamauchi M, Yamakage M. [Utility of ultrasound imaging for epidural blood patch in postdural puncture headache patients after caesarean section]. Masui. 2011 Jul;60(7):870-2. Japanese. |
| BG001 | Landmarks | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Type of anaesthesia | Count of Participants | Participants |
|
| OG001 | Landmarks | 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. |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | An expected average of 10 minutes after the technique. |
|
|
|
|
| Primary | Number of Attempts Required. | How many times did the operator withdraw the needle and repeated the puncture. | Posted | Mean | Standard Deviation | number of attempts | An expected average of 10 minutes after the technique.. |
|
|
|
|
| Primary | Repositioning Frequency. | How many times did the operator change the trajectory of the needle. | Posted | Mean | Standard Deviation | repositioning attempts | An expected average of 10 minutes after the technique. |
|
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | An expected average of 10 minutes after the technique. |
|
|
|
|
| Primary | Time Required. | Time passed from the positioning of the patient on the table until the end of the neuraxial anesthesia | Posted | Mean | Standard Deviation | seconds | An expected average of 15 minutes. |
|
|
|
|
| Secondary | Depth of the Epidural Space Measured by Ultrasound. | The distance between the skin and the ligamentum flavum measured by the built-in ultrasound caliper. | Data not collected | Posted | An expected average of 3 minutes after the beginning of the procedure. |
|
|
| Secondary | 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. | Not Posted | An expected average of 5 minutes after the beginning of the procedure. | Participants |
| Secondary | Number of Patients With Low Back Pain. | Number of patients who reported low back pain after the technique. | Posted | Count of Participants | Participants | 12hours and 24hours after the end of the technique. |
|
|
|
| Secondary | 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). | Data not collected | Posted | 12hours and 24hours after the end of the technique. |
|
|
| Secondary | 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). | Posted | Count of Participants | Participants | 12hours after the end of the technique. |
|
|
|
| Secondary | Number of Participants With Any Complication. | Number of patients who had any complication after the technique | Posted | Count of Participants | Participants | 24hours after the end of the technique. |
|
|
|
| 0 |
| 80 |
| 0 |
| 80 |
| 80 |
| 80 |
| EG001 | Landmarks | 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. | 0 | 66 | 0 | 66 | 66 | 66 |
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| No |
|