Pre-procedural Ultrasound Techniques Versus Conventional Landmark Technique of Spinal Anesthesia in Elderly Patients

NCT ID: NCT02658058

Last Updated: 2019-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2018-01-31

Brief Summary

Traditionally, spinal anesthesia is performed using the palpation of bony landmark to identify the level and point of entry of the spinal needle. Recently, ultrasound imaging has become an increasingly popular procedure among anesthesiologists to guide neuraxial blockade. Most of the studies on pre-procedural ultrasound-guided neuraxial techniques are limited to a midline approach using a transverse median views. The parasagittal oblique view consistently offers better ultrasound view of the neuraxis compared to the transverse median view. However, it is still not evident whether these superior parasagittal oblique views will lead to an easier paramedian needle insertion. In the literature, there are no studies directly comparing the US-guided paramedian approach using the parasagittal oblique (PSO) view, the US-guided midline approach using the transverse median view, and the conventional landmark midline approach to perform spinal anesthesia in the elderly patients, in particular for the teaching of novice anesthesia residents.

Detailed Description

The aim of this study is to find out the optimal technique to perform spinal anesthesia by residents in training. Thus the investigators will compare preprocedural ultrasound-guided paramedian technique using parasagittal oblique view vs preprocedural ultrasound-guided midline technique using transverse median view vs landmark-guided midline technique of spinal anesthesia in the elderly population. Our hypothesis is that both preprocedural US-guided techniques are superior to the conventional landmark-guided midline technique with regard to ease of performance defined as success rate at first attempt, number of puncture attempts, spinal procedure time, and patient satisfaction.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Landmark technique

As intervention, patients in this group are administered landmark guided midline spinal anesthesia.

Group Type: ACTIVE_COMPARATOR

Landmark technique

Intervention Type: OTHER

The site of needle insertion will be determined via manual palpation. A line joining the superior aspect of the iliac crests posteriorly (Tuffier's line') will be used as a surface landmark for the L4 vertebral body. The midline will be established by palpation of the tips of the spinous processes, and the site of needle insertion will be marked on the patient's skin. The interspace that appears widest, based on manual palpation, will be chosen for the first attempt. If the first attempt is unsuccessful, further attempts can be made at the same interspace or another interspace.

Ultrasound-guided paramedian technique

As intervention, patients in this group are administered spinal anesthesia based on preprocedural ultrasound-guided paramedian technique using parasagittal oblique view

Group Type: EXPERIMENTAL

Ultrasound-guided paramedian technique

Intervention Type: OTHER

The transducer will be applied in the parasagittal plane and the intervertebral levels will be identified by counting upwards from the sacrum (continuous hyperechoic line). The probe will then be angled obliquely to obtain a PSO view. The locations of the interlaminar spaces will be identified by visualizing the ligamentum flavum-dura mater complex and the posterior aspect of the vertebral body. The angulation at which the ligamentum flavum-dura mater complex and posterior vertebral body are best visualized will be considered the optimal angle for needle insertion and clearly communicated to the operator. The interlaminar space will be centered on the ultrasound screen and a skin marker will be used to make a mark on the patient's back at the middle of the ultrasound probe.

Ultrasound-guided midline technique

As intervention, patients in this group are administered spinal anesthesia based on preprocedural ultrasound-guided midline technique using transverse median view

Group Type: EXPERIMENTAL

Ultrasound-guided midline technique

Intervention Type: OTHER

The transducer will be applied in the parasagittal plane, and after identification of the intervertebral levels, the probe will be rotated 90 degree to obtain the TM view. The transducer is moved in a cephalad-caudad direction between the spinous processes of L2 and L5 vertebra. The probe will be tilted slightly up and down to ensure a sufficient echogenic window at the selected intervertebral space. A skin marker will be used to make a mark on the patient's back at the middle of the ultrasound probe. The angle at which the ligamentum flavum-dura mater complex and the posterior aspect of the vertebral body are best visualized will be noted

Interventions

Landmark technique

The site of needle insertion will be determined via manual palpation. A line joining the superior aspect of the iliac crests posteriorly (Tuffier's line') will be used as a surface landmark for the L4 vertebral body. The midline will be established by palpation of the tips of the spinous processes, and the site of needle insertion will be marked on the patient's skin. The interspace that appears widest, based on manual palpation, will be chosen for the first attempt. If the first attempt is unsuccessful, further attempts can be made at the same interspace or another interspace.

Intervention Type: OTHER

Ultrasound-guided paramedian technique

The transducer will be applied in the parasagittal plane and the intervertebral levels will be identified by counting upwards from the sacrum (continuous hyperechoic line). The probe will then be angled obliquely to obtain a PSO view. The locations of the interlaminar spaces will be identified by visualizing the ligamentum flavum-dura mater complex and the posterior aspect of the vertebral body. The angulation at which the ligamentum flavum-dura mater complex and posterior vertebral body are best visualized will be considered the optimal angle for needle insertion and clearly communicated to the operator. The interlaminar space will be centered on the ultrasound screen and a skin marker will be used to make a mark on the patient's back at the middle of the ultrasound probe.

Intervention Type: OTHER

Ultrasound-guided midline technique

The transducer will be applied in the parasagittal plane, and after identification of the intervertebral levels, the probe will be rotated 90 degree to obtain the TM view. The transducer is moved in a cephalad-caudad direction between the spinous processes of L2 and L5 vertebra. The probe will be tilted slightly up and down to ensure a sufficient echogenic window at the selected intervertebral space. A skin marker will be used to make a mark on the patient's back at the middle of the ultrasound probe. The angle at which the ligamentum flavum-dura mater complex and the posterior aspect of the vertebral body are best visualized will be noted

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients scheduled for surgery amenable to spinal anesthesia, aged more than 60 years, with American Society of Anesthesiologists physical status 1 to 4.

Exclusion Criteria

• Patients who are unable to give consent, refuse spinal anesthesia, have spinal abnormalities (including scoliosis and previous spine operations with instrumentation) or have contraindications to spinal anesthesia, including allergy to local anesthetics or a bleeding diathesis

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American University of Beirut Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sahar Sayyid

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sahar Siddik-Sayyid, MD

Role: PRINCIPAL_INVESTIGATOR

American University of Beirut Medical Center

Locations

American University of Beirut Medical center

Beirut, , Lebanon

Countries

Lebanon

References

Rizk MS, Zeeni CA, Bouez JN, Bteich NJ, Sayyid SK, Alfahel WS, Siddik-Sayyid SM. Preprocedural ultrasound versus landmark techniques for spinal anesthesia performed by novice residents in elderly: a randomized controlled trial. BMC Anesthesiol. 2019 Nov 11;19(1):208. doi: 10.1186/s12871-019-0882-8.

Reference Type: DERIVED

PMID: 31711438 (View on PubMed)

Other Identifiers

ANES.SS.13

Identifier Type: -

Identifier Source: org_study_id