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Completed

NCT Number: NCT02171975

Ultrasound - Guided Paramedian Techniques in Spinal Anesthesia

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.

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Key information

Conditions

Anaesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South Infirmary Victoria University Hospital

Cork, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pre-procedure ultrasound guided paramedian spinal

Procedure

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.

Conventional landmark guided midline spinal anaesthetic

Procedure

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

Primary outcomes

  1. Number of passes

    Time frame: Up to 45 minutes from the start of insertion of spinal needled for administration of spinal anaesthetic

    The 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 outcomes

  1. Number of spinal needle insertion attempts

    Time frame: Up to 45 minutes from the start of insertion of spinal needled for administration of spinal anaesthetic

    number of spinal needle insertion attempts (defined as the number of times the spinal needle was withdrawn from the skin and reinserted) were noted

  2. Blood in spinal needle

    Time frame: Up to 45 minutes from the start of insertion of spinal needled for administration of spinal anaesthetic

    Presence of blood in spinal needle

  3. Time for identifying landmarks

    Time frame: Up to 10 minutes fraom start of plapating for landmarks - Completed once anethetist declares that markings are complete

    Time 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

  4. Time taken for performing spinal anesthetic

    Time frame: Up to 45 minutes from the start of insertion of spinal needled for administration of spinal anaesthetic

    defined as time taken from insertion of introducer needle to completion of injection

  5. Incidence of radicular pain

    Time frame: Up to 24 hours after administration of spinal anaesthetic

    Shooting pain going down along one of the dermatomal levels in the leg

  6. Presence of paresthesia

    Time frame: Up to 24 hours after administration of spinal anaesthetic

    Paresthesia along dermatomal distribution during performing spinal anaesthetic

  7. Grading of palpated landmarks

    Time frame: Up to 10 minutes fraom start of plapating for landmarks - Completed once anethetist declares that markings are complete

    Anesthesiologist palpated the landmarks after positioning and graded the ease of palpation on a 4 point scale (easy, moderate, difficult or impossible)

  8. Peri-procedural VAS scores of pain at injection site

    Time frame: up to 30 minutes following spinal anaesthetic injection and prior to sedation

    After 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)

  9. peri-procedural discomfort scores

    Time frame: up to 30 minutes following spinal anaesthetic injection and prior to sedation

    peri-procedural discomfort scores measured using an 11 point verbal rating measured (0= no discomfort, 10=most discomfort imaginable).

  10. Level of block

    Time frame: 15 minutes after spinal anaesthetic injection

    Dermatomal level at which loss of cold sensation (ethyl chloride spray) occurs

Sponsors and collaborators

Lead sponsor

Cork University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 24, 2014
Registry last updated
Jun 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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