Ultrasound - Guided Paramedian Techniques in Spinal Anesthesia

NCT ID: NCT02171975

Last Updated: 2014-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-05-31

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.

Conditions

Anaesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group C

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

Group Type: ACTIVE_COMPARATOR

Conventional landmark guided midline spinal anaesthetic

Intervention Type: PROCEDURE

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

Group P

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

Group Type: EXPERIMENTAL

pre-procedure ultrasound guided paramedian spinal

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Conventional landmark guided midline spinal anaesthetic

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cork University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Karthikeyan Kallidaikurichi Srinivasan

Specialist Registrar,Anaesthetics,Cork University Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karthikeyan Kallidaikurichi Srinivasan, FCARCSI,MD

Role: PRINCIPAL_INVESTIGATOR

Cork University Hospital

Locations

South Infirmary Victoria University Hospital

Cork, Cork, Ireland

Countries

Ireland

Other Identifiers

ECM 4(j) 04/02/14

Identifier Type: -

Identifier Source: org_study_id