Ultrasound - Guided Paramedian Techniques in Spinal Anesthesia

NCT02171975 | Completed

• 1 other identifier: ECM 4(j) 04/02/14
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Anaesthesia

Keywords

Spinal anaesthesia; Ultrasound pre-procedure guided; Paramedian spinal

Outcome Measures

Primary Outcomes (1)

• 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 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 anaesthetic.

Procedure: Conventional landmark guided midline spinal anaesthetic

Group P

EXPERIMENTAL

This group had their spinal anaesthetic done based on pre-procedure ultrasound guided paramedian spinal

Procedure: pre-procedure ultrasound guided paramedian spinal

Interventions

pre-procedure ultrasound guided paramedian spinal PROCEDURE

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.

Group P

Conventional landmark guided midline spinal anaesthetic PROCEDURE

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

Group C

Eligibility Criteria

• Age: 18 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 were 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) were excluded from the study.

Sponsors & Collaborators

• Cork University Hospital: lead

Study Sites (1)

South Infirmary Victoria University Hospital

Cork, Cork, Ireland

Location

Study Officials

• Karthikeyan Kallidaikurichi Srinivasan, FCARCSI,MD

  Cork University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 19, 2014
• First Posted: June 24, 2014
• Study Start: February 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 24, 2014

Record last verified: 2014-06

Locations

IE (1)