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Ultrasound - Guided Paramedian Techniques in Spinal Anesthesia

A Comparison of Conventional Landmark Guided Midline Versus Pre-procedure Ultrasound - Guided Paramedian Techniques in Spinal Anesthesia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02171975
Enrollment
100
Registered
2014-06-24
Start date
2014-02-28
Completion date
2014-05-31
Last updated
2014-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaesthesia

Keywords

Spinal anaesthesia, Ultrasound pre-procedure guided, Paramedian spinal

Brief summary

Multiple passes and attempts while administering spinal anesthesia are associated with a greater incidence of post dural-puncture headache, paraesthesia and spinal hematoma. The investigators hypothesised that the routine use of pre-procedural ultrasound-guided paramedian spinals reduces the number of passes required to achieve enter the subarachnoid space when compared to the conventional landmark-guided midline approach.

Detailed description

Spinal anesthesia is widely performed using a surface landmark based 'blind' technique. Multiple passes and attempts while administering spinal anesthesia are associated with a greater incidence of post dural-puncture headache, paraesthesia and spinal hematoma. Real time and pre-procedural neuraxial ultrasound techniques have been used to improve the success rate of spinal anesthesia. The use of real time ultrasound-guided spinal anesthesia has to date been limited to case series and case reports. Its use may be limited by the requirement for wide bore needles and the technical difficulties associated with simultaneous ultrasound scanning and needle advancement. The use of pre-procedural ultrasound has been shown to increase the first pass success rate for spinal anesthesia only in patients with difficult surface anatomic landmarks.No technique has been shown to improve the success rate of dural puncture when applied routinely to all patients. Studies on pre-procedural ultrasound-guided spinal techniques are limited to a midline approach using a transverse median view (TM). The parasagittal oblique (PSO) view consistently offers better ultrasound view of the neuraxis compared to TM views. However no studies have been conducted to assess whether these superior PSO views translate into easier paramedian needle insertion. We hypothesised that the routine use of pre-procedural ultrasound-guided paramedian spinal technique results in less number of passes required to enter the subarachnoid space when compared to the conventional landmark based midline approach.

Interventions

PROCEDUREpre-procedure ultrasound guided paramedian spinal

In group P, a portable ultrasound unit was used for initial pre-procedural marking. The interspinous space at which the clearest image of the anterior complex (ligamentum flavum dura complex- LFD) and posterior complex (posterior longitudinal ligament- PLL) was obtained, was selected. At the selected interspace, and with the probe positioned to obtain the clearest ultrasound image, a skin marker was used to mark the midpoint of the long border of the probe and the midpoints of the short borders of the probe . At the same horizontal level as the midpoint of the long border of the probe, the midpoint of the line drawn between the two short border midpoints of the probe was used as paramedian insertion point for the spinal needle.

PROCEDUREConventional landmark guided midline spinal anaesthetic

Spinal anaesthesia was administered based on conventional landmark based midline approach.

Sponsors

Cork University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* all consented patients scheduled to undergo elective total knee or total hip arthroplasty under spinal anesthesia were included in the study.

Exclusion criteria

* Patients with contraindications to spinal anesthesia (allergy to local anesthetic, coagulopathy, local infection and indeterminate neurological disease) were excluded from the study.

Design outcomes

Primary

MeasureTime frameDescription
Number of passesUp to 45 minutes from the start of insertion of spinal needled for administration of spinal anaestheticThe number of passes, defined as the number of forward advancements of the spinal needle in a given interspinous space (i.e. withdrawal and redirection of spinal needle without exiting the skin)

Secondary

MeasureTime frameDescription
Blood in spinal needleUp to 45 minutes from the start of insertion of spinal needled for administration of spinal anaestheticPresence of blood in spinal needle
Time for identifying landmarksUp to 10 minutes fraom start of plapating for landmarks - Completed once anethetist declares that markings are completeTime for identifying landmarks in group C was defined as time from which the anesthesiologist started palpating to identify the landmarks to completion of the process as declared by the anesthesiologist. In group P it was defined as time from which the ultrasound probe was placed on the skin to the anesthesiologist declaring that the markings are completed
Time taken for performing spinal anestheticUp to 45 minutes from the start of insertion of spinal needled for administration of spinal anaestheticdefined as time taken from insertion of introducer needle to completion of injection
Incidence of radicular painUp to 24 hours after administration of spinal anaestheticShooting pain going down along one of the dermatomal levels in the leg
Number of spinal needle insertion attemptsUp to 45 minutes from the start of insertion of spinal needled for administration of spinal anaestheticnumber of spinal needle insertion attempts (defined as the number of times the spinal needle was withdrawn from the skin and reinserted) were noted
Grading of palpated landmarksUp to 10 minutes fraom start of plapating for landmarks - Completed once anethetist declares that markings are completeAnesthesiologist palpated the landmarks after positioning and graded the ease of palpation on a 4 point scale (easy, moderate, difficult or impossible)
Peri-procedural VAS scores of pain at injection siteup to 30 minutes following spinal anaesthetic injection and prior to sedationAfter positioning and prior to administration of sedation, patients were asked for their peri-procedural pain scores measured using an 11 point verbal rating scale (0=no pain, 10=most pain imaginable)
peri-procedural discomfort scoresup to 30 minutes following spinal anaesthetic injection and prior to sedationperi-procedural discomfort scores measured using an 11 point verbal rating measured (0= no discomfort, 10=most discomfort imaginable).
Level of block15 minutes after spinal anaesthetic injectionDermatomal level at which loss of cold sensation (ethyl chloride spray) occurs
Presence of paresthesiaUp to 24 hours after administration of spinal anaestheticParesthesia along dermatomal distribution during performing spinal anaesthetic

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026