Ultrasound for Neuraxial Anesthesia

NCT02553746 | Completed Results

• 1 other identifier: 14073
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lumbar Ultrasound

Keywords

Ultrasound; Spinal anesthesia; Epidural anesthesia

Outcome Measures

Primary Outcomes (6)

• 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.

Secondary Outcomes (6)

• Depth of the Epidural Space Measured by Ultrasound.

  An expected average of 3 minutes after the beginning of the procedure.

• Depth of the Epidural Space Measured by the Needle.

  An expected average of 5 minutes after the beginning of the procedure.

• Number of Patients With Low Back Pain.

  12hours and 24hours after the end of the technique.

• Low Back Pain Intensity.

  12hours and 24hours after the end of the technique.

• Patient Satisfaction.

  12hours after the end of the technique.

Study Arms (2)

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.

Interventions

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.

Ultrasound

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.

Landmarks

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• 424 General Military Hospital: lead

Study Sites (1)

424 Army General Hospital Department of Anesthesia

Thessaloniki, 56429, Greece

Location

Related Publications (32)

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• 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.

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• 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.

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• 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.

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• 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.

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Results Point of Contact

• Title: Georgios Kotsovolis
• Organization: 424 Army General Hospital

gskotsos@gmail.com

+306948182743

Study Officials

• Georgios Kotsovolis

  424 Army General Hospital of Thessaloniki

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: September 18, 2015
• Study Start: September 1, 2015
• Primary Completion: January 10, 2018
• Study Completion: January 10, 2018
• Last Updated: August 12, 2019
• Results First Posted: August 12, 2019

Record last verified: 2019-07

Locations

GR (1)