Ultrasound - Guided Paramedian Techniques in Spinal Anesthesia

A Comparison of Conventional Landmark Guided Midline Versus Pre-procedure 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.

Study Overview

• Status: Completed
• Conditions: Anaesthesia
• Intervention / Treatment: Procedure: Conventional landmark guided midline spinal anaesthetic; Procedure: pre-procedure ultrasound guided paramedian spinal

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Cork, Ireland
    • South Infirmary Victoria University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group C; Patients in this group underwent Conventional landmark guided midline spinal anaesthetic.	Procedure: Conventional landmark guided midline spinal anaesthetic; Spinal anaesthesia was administered based on conventional landmark based midline approach.
Experimental: Group P; This group had their spinal anaesthetic done based on pre-procedure ultrasound guided paramedian spinal	Procedure: pre-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of passes	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)	Up to 45 minutes from the start of insertion of spinal needled for administration of spinal anaesthetic

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of spinal needle insertion attempts	number of spinal needle insertion attempts (defined as the number of times the spinal needle was withdrawn from the skin and reinserted) were noted	Up to 45 minutes from the start of insertion of spinal needled for administration of spinal anaesthetic
Blood in spinal needle	Presence of blood in spinal needle	Up to 45 minutes from the start of insertion of spinal needled for administration of spinal anaesthetic
Time for identifying landmarks	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	Up to 10 minutes fraom start of plapating for landmarks - Completed once anethetist declares that markings are complete
Time taken for performing spinal anesthetic	defined as time taken from insertion of introducer needle to completion of injection	Up to 45 minutes from the start of insertion of spinal needled for administration of spinal anaesthetic
Incidence of radicular pain	Shooting pain going down along one of the dermatomal levels in the leg	Up to 24 hours after administration of spinal anaesthetic
Presence of paresthesia	Paresthesia along dermatomal distribution during performing spinal anaesthetic	Up to 24 hours after administration of spinal anaesthetic
Grading of palpated landmarks	Anesthesiologist palpated the landmarks after positioning and graded the ease of palpation on a 4 point scale (easy, moderate, difficult or impossible)	Up to 10 minutes fraom start of plapating for landmarks - Completed once anethetist declares that markings are complete
Peri-procedural VAS scores of pain at injection site	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)	up to 30 minutes following spinal anaesthetic injection and prior to sedation
peri-procedural discomfort scores	peri-procedural discomfort scores measured using an 11 point verbal rating measured (0= no discomfort, 10=most discomfort imaginable).	up to 30 minutes following spinal anaesthetic injection and prior to sedation
Level of block	Dermatomal level at which loss of cold sensation (ethyl chloride spray) occurs	15 minutes after spinal anaesthetic injection

Collaborators and Investigators

• Sponsor: Cork University Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: June 19, 2014
• First Submitted That Met QC Criteria: June 20, 2014
• First Posted (Estimate): June 24, 2014

Study Record Updates

• Last Update Posted (Estimate): June 24, 2014
• Last Update Submitted That Met QC Criteria: June 20, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Spinal anaesthesia; Ultrasound pre-procedure guided; Paramedian spinal
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: ECM 4(j) 04/02/14