Study Results
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View full resultsBasic Information
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COMPLETED
NA
146 participants
INTERVENTIONAL
2015-09-30
2018-01-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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 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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Surgery under general anesthesia and preoperative placement of epidural catheter for postoperative analgesia.
* ASA 1-3.
Exclusion Criteria
* Low back pain at the time of anesthesia
18 Years
85 Years
ALL
No
Sponsors
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424 General Military Hospital
OTHER
Responsible Party
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Georgios Kotsovolis
Doctor
Principal Investigators
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Georgios Kotsovolis
Role: PRINCIPAL_INVESTIGATOR
424 Army General Hospital of Thessaloniki
Locations
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424 Army General Hospital Department of Anesthesia
Thessaloniki, , Greece
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Hotta K. [Ultrasound-guided epidural block]. Masui. 2008 May;57(5):556-63. Japanese.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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14073
Identifier Type: -
Identifier Source: org_study_id
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