Landmark Guided Midline Versus Pre-procedural Ultrasound Guided Paramedian at L5S1 for Spinal Anaesthesia

NCT02189681 | Completed

• 1 other identifier: L5S1 study
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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. Routine use of pre-procedure ultrasound guided paramedian approach results in 50% reduction in number of passes required for spinal anaesthetic, from a study at Cork University Hospital (awaiting publication). L5-S1 is the widest interlaminar space and provides minimal contribution to overall movement of lumbar spine.This interspinous space might still be accessible even if the patient has minimal spine flexion. We also noted that spinal needle insertion via the L5-S1 interspace was associated with the fewest passes in the pre-procedure guided ultrasound group (although non-significant). We hypothesise that the routine use of pre-procedural ultrasound-guided paramedian spinal technique at L5S1 interspinous space will result in fewer needle passes to enter the subarachnoid space when compared to the conventional landmark based midline approach.

Conditions

Anaesthesia

Keywords

spinal anaesthesia; ultrasound; paramedian

Outcome Measures

Primary Outcomes (1)

• difference in number of passes between the two groups.

  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)

  30 minutes within completion of apinal anaesthetic

Secondary Outcomes (10)

• Number of spinal needle insertion attempts

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

• 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

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

• Time taken for performing spinal anesthetic

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

• Incidence of radicular pain

  Up to 24 hours after administration of spinal anaesthetic

Study Arms (2)

Group C

ACTIVE COMPARATOR

Patients in this group underwent Conventional landmark guided midline spinal anaesthesia.

Procedure: Conventional landmark guided midline spinal anaesthesia; Device: spinal anaesthesia

Group P

EXPERIMENTAL

This group had pre-procedure ultrasound guided L5S1 paramedian spinal anaesthesia performed

Procedure: pre-procedure ultrasound guided L5S1 paramedian spinal; Device: spinal anaesthesia

Interventions

Conventional landmark guided midline spinal anaesthesia PROCEDURE

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

Group C

pre-procedure ultrasound guided L5S1 paramedian spinal PROCEDURE

In group P, a portable ultrasound unit was used for initial pre-procedural marking. The L5 S1 interspinous space with best image of the anterior complex (ligamentum flavum dura complex- LFD) and posterior complex (posterior longitudinal ligament- PLL) was obtained. At this 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.Spinal anaesthesia is then administered based on these landmarks.

Group P

spinal anaesthesia DEVICE

Spinal anaesthesia is administered with appropriate spinal needle

Group C; Group P

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All consented patients scheduled to undergo elective total knee or total hip arthroplasty under spinal anesthesia will be included in the study.

You may not qualify if:

• Patients with contraindications to spinal anesthesia (allergy to local anesthetic, coagulopathy, local infection and indeterminate neurological disease) will be excluded from the study.

Sponsors & Collaborators

• Cork University Hospital: lead

Study Sites (1)

Cork University Hospital

Cork,Ireland, Cork, Ireland

Location

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Karthikeyan Kallidaikurichi Srinivasan, FCARCSI,MD

  Cork University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Registrar,Anaesthetics,Cork University Hospital

Study Record Dates

• First Submitted: July 5, 2014
• First Posted: July 14, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 28, 2015

Record last verified: 2015-08

Locations

IE (1)