Clinical trial NCT02171975: Ultrasound - Guided Paramedian Techniques in Spinal Anesthesia
Official title: A Comparison of Conventional Landmark Guided Midline Versus Pre-procedure Ultrasound - Guided Paramedian Techniques in Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anaesthesia
Keywords: Spinal anaesthesia
Ultrasound pre-procedure guided
Paramedian spinal
Lead sponsor: Cork University Hospital
Sponsor class: OTHER
First posted: 2014-06-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of passes
timeFrame: Up to 45 minutes from the start of insertion of spinal needled for administration of spinal anaesthetic
Secondary outcomes:
measure: Number of spinal needle insertion attempts
timeFrame: Up to 45 minutes from the start of insertion of spinal needled for administration of spinal anaesthetic
measure: Blood in spinal needle
timeFrame: Up to 45 minutes from the start of insertion of spinal needled for administration of spinal anaesthetic
measure: Time for identifying landmarks
timeFrame: Up to 10 minutes fraom start of plapating for landmarks - Completed once anethetist declares that markings are complete
measure: Time taken for performing spinal anesthetic
timeFrame: Up to 45 minutes from the start of insertion of spinal needled for administration of spinal anaesthetic
measure: Incidence of radicular pain
timeFrame: Up to 24 hours after administration of spinal anaesthetic
measure: Presence of paresthesia
timeFrame: Up to 24 hours after administration of spinal anaesthetic
measure: Grading of palpated landmarks
timeFrame: Up to 10 minutes fraom start of plapating for landmarks - Completed once anethetist declares that markings are complete
measure: Peri-procedural VAS scores of pain at injection site
timeFrame: up to 30 minutes following spinal anaesthetic injection and prior to sedation
measure: peri-procedural discomfort scores
timeFrame: up to 30 minutes following spinal anaesthetic injection and prior to sedation
measure: Level of block
timeFrame: 15 minutes after spinal anaesthetic injection
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: South Infirmary Victoria University Hospital
Study officials:
affiliation: Cork University Hospital
name: Karthikeyan Kallidaikurichi Srinivasan, FCARCSI,MD
role: PRINCIPAL_INVESTIGATOR
References: