Ultrasound - Guided Paramedian Techniques in Spinal Anesthesia

Anaesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02171975
• Other study ID #: ECM 4(j) 04/02/14
• Status: Completed
• Phase: N/A
• First received: June 19, 2014
• Last updated: June 20, 2014
• Start date: February 2014
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• Source: Cork University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Irish Medicines Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anaesthesia

Intervention

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.
• Conventional landmark guided midline spinal anaesthetic
Spinal anaesthesia was administered based on conventional landmark based midline approach.

Locations

Country	Name	City	State
Ireland	South Infirmary Victoria University Hospital	Cork

Sponsors (1)

Lead Sponsor	Collaborator
Cork University Hospital

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	Presence of paresthesia	Paresthesia along dermatomal distribution during performing spinal anaesthetic	Up to 24 hours after administration of spinal anaesthetic	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Level of block	Dermatomal level at which loss of cold sensation (ethyl chloride spray) occurs	15 minutes after spinal anaesthetic injection	No