Ultrasound Guided Midline vs Landmark Paramedian Continous Spinal Anesthesia in the Elderly

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity Tunis El Manar

About this trial

Former clinical studies have reported the superiority of the landmark guided paramedian approach above the classical landmark guided midline approach for the continuous spinal anesthesia especially in the elderly. On the other hand, more recent clinical trials have suggested that the use of ultrasound to guide spinal anesthesia will be safer and more effective than the conventional palpation-guided technique.

The aim of this study will be to compare the conventional "blind" landmark paramedian approach to the ultrasound "modern" guided midline approach for the continuous spinal anesthesia in the elderly with hip fractures.

Patients will randomly divided into two groups:

Group(PML): will undergo conventional landmark guided paramedian continuous spinal anesthesia Group (MUS): will undergo ultrasound guided midline continuous spinal anesthesia

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

all consented patients aged over 65 years old scheduled to undergo surgery for hip fracture under continuous spinal anesthesia with American Society of Anesthesiologists ASA physical status classification from I to III

Disqualifiers

contraindications to spinal anesthesia ( allergy to local anesthetic, coagulopathy, infection at the site of injection)

previous history of lumbar spine surgery

per operative severe complication with conversion to general anesthesia

Trial design

Design model

Parallel

Treatments tested in this trial

  • conventional landmark paramedian technique

    Procedure/Surgery

    a blind landmark scanning will be done and skin marking of the best palpable spinous process will be made. the site of injection will be determined by palpation. continuous spinal anesthesia will be performed via paramedian approach.

  • preprocedural ultrasound guided midline technique

    Procedure/Surgery

    a preprocedural ultrasound scanning will be done, and skin marking of the best quality space will be made. the site of injection and the insertion angle of the needle will be determined by ultrasound. continuous spinal anesthesia will be performed via midline approach.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: paramedian landmark groupExperimental treatment 1 intervention
Group B: Midline ultrasound groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

the difference in number of needle passes between the two groups

the number of forward advancements of the Tuohy needle in a given interspinous space (i.e withdrawal and redirection of Tuohy needle without exiting the skin)

Time frame
from the first insertion of the needle until the fixation of the continuous spinal anesthesia catheter to patient skin

Secondary outcomes

1

number of spinal needle insertion attempts

the number of times the tuohy needle was withdrawn from the skin and reinserted

Time frame
from the first insertion of the needle until the fixation of the continuous spinal anesthesia catheter to patient skin
2

the rate of first pass success

a single needle insertion with no redirection

Time frame
from the first insertion of the needle until the fixation of the continuous spinal anesthesia catheter to patient skin
3

time for identifying landmarks

in group PML: time from which the anesthesiologist started palpating to identify the landmarks to the needle entry point marking in group MUS: time from which the ultrasound probe was placed on the skin to the needle entry point marking

Time frame
time taken from start of palpating or ultrasound scanning to the marking of the needle entry point
4

time taken for performing continuous spinal anesthesia

time from first needle insertion to fixation of continuous spinal anesthesia catheter to patient skin

Time frame
time taken from the start of the first insertion of the needle to the completion of fixation of the catheter to patient skin

Other outcomes

Sponsors and contacts

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