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Ultrasound - Guided Paramedian Techniques in Spinal Anesthesia

Not Applicable
Completed
Conditions
Anaesthesia
Interventions
Procedure: Conventional landmark guided midline spinal anaesthetic
Procedure: pre-procedure ultrasound guided paramedian spinal
Registration Number
NCT02171975
Lead Sponsor
Cork University Hospital
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
100
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group CConventional landmark guided midline spinal anaestheticPatients in this group underwent Conventional landmark guided midline spinal anaesthetic.
Group Ppre-procedure ultrasound guided paramedian spinalThis group had their spinal anaesthetic done based on pre-procedure ultrasound guided paramedian spinal
Primary Outcome Measures
NameTimeMethod
Number of passesUp 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 Outcome Measures
NameTimeMethod
Time for identifying landmarksUp 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

Time taken for performing spinal anestheticUp 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

Incidence of radicular painUp to 24 hours after administration of spinal anaesthetic

Shooting 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 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

Blood in spinal needleUp to 45 minutes from the start of insertion of spinal needled for administration of spinal anaesthetic

Presence of blood in spinal needle

Presence of paresthesiaUp to 24 hours after administration of spinal anaesthetic

Paresthesia along dermatomal distribution during performing spinal anaesthetic

Grading of palpated landmarksUp 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)

Peri-procedural VAS scores of pain at injection siteup 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)

peri-procedural discomfort scoresup 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).

Level of block15 minutes after spinal anaesthetic injection

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

Trial Locations

Locations (1)

South Infirmary Victoria University Hospital

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Cork, Ireland

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