Ultrasound for Neuraxial Anesthesia

Lumbar Ultrasound Clinical Trial

Official title:

Study of the Use of Ultrasound Scan for Lumbar Regional Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02553746
• Other study ID #: 14073
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: January 10, 2018

Study information

• Verified date: July 2019
• Source: 424 General Military Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: January 10, 2018
• Est. primary completion date: January 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• History of lumbar spinal surgery.

• Low back pain at the time of anesthesia

Related Conditions & MeSH terms

• Lumbar Ultrasound

Intervention

Device:
• 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.

Procedure:
• 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.

Locations

Country	Name	City	State
Greece	424 Army General Hospital Department of Anesthesia	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
424 General Military Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (32)

Ali ME, Laurito CE. Ultrasound guidance for epidural catheter placement: a coming of age? J Clin Anesth. 2005 May;17(3):235-6. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Grau T, Leipold RW, Conradi R, Martin E. Ultrasound control for presumed difficult epidural puncture. Acta Anaesthesiol Scand. 2001 Jul;45(6):766-71. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Helayel PE, da Conceição 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. — View Citation

Hotta K. [Ultrasound-guided epidural block]. Masui. 2008 May;57(5):556-63. Review. Japanese. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Peng PW, Rofaeel A. Using ultrasound in a case of difficult epidural needle placement. Can J Anaesth. 2006 Mar;53(3):325-6. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	An expected average of 10 minutes after the technique.
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.	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.	An expected average of 10 minutes after the technique..
Primary	Repositioning Frequency.	How many times did the operator change the trajectory of the needle.	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.	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	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.	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.	An expected average of 5 minutes after the beginning of the procedure.
Secondary	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.
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).	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).	12hours after the end of the technique.
Secondary	Number of Participants With Any Complication.	Number of patients who had any complication after the technique	24hours after the end of the technique.