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

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ClinicalTrials.gov Identifier: NCT02189681
Recruitment Status : Completed
First Posted : July 14, 2014
Last Update Posted : August 28, 2015
Sponsor:
Information provided by (Responsible Party):
Karthikeyan Kallidaikurichi Srinivasan, Cork University Hospital

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.


Condition or disease Intervention/treatment Phase
Anaesthesia Procedure: Conventional landmark guided midline spinal anaesthesia Procedure: pre-procedure ultrasound guided L5S1 paramedian spinal Device: spinal anaesthesia Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Official Title: Comparison of Conventional Landmark Guided Midline (Group C) Versus Pre-procedural Ultrasound Guided Paramedian at L5S1 (Group P) Technique for Spinal Anaesthesia
Study Start Date : July 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Active Comparator: Group C
Patients in this group underwent Conventional landmark guided midline spinal anaesthesia.
Procedure: Conventional landmark guided midline spinal anaesthesia
Spinal anaesthesia was administered based on conventional landmark based midline approach.

Device: spinal anaesthesia
Spinal anaesthesia is administered with appropriate spinal needle

Experimental: Group P
This group had pre-procedure ultrasound guided L5S1 paramedian spinal anaesthesia performed
Procedure: pre-procedure ultrasound guided L5S1 paramedian spinal
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.

Device: spinal anaesthesia
Spinal anaesthesia is administered with appropriate spinal needle




Primary Outcome Measures :
  1. difference in number of passes between the two groups. [ Time Frame: 30 minutes within completion of apinal anaesthetic ]
    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)


Secondary Outcome Measures :
  1. Number of spinal needle insertion attempts [ Time Frame: Up to 45 minutes from the start of insertion of spinal needled for administration of spinal anaesthetic ]
    number of spinal needle insertion attempts (defined as the number of times the spinal needle was withdrawn from the skin and reinserted) were noted

  2. Blood in spinal needle [ Time Frame: Up to 45 minutes from the start of insertion of spinal needled for administration of spinal anaesthetic ]
    Presence of blood in spinal needle

  3. Time for identifying landmarks [ Time Frame: Up to 10 minutes fraom start of plapating for landmarks - Completed once anethetist declares that markings are complete ]
    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

  4. Time taken for performing spinal anesthetic [ Time Frame: Up to 45 minutes from the start of insertion of spinal needled for administration of spinal anaesthetic ]
    defined as time taken from insertion of introducer needle to completion of injection

  5. Incidence of radicular pain [ Time Frame: Up to 24 hours after administration of spinal anaesthetic ]
    Shooting pain going down along one of the dermatomal levels in the leg

  6. Presence of paresthesia [ Time Frame: Up to 24 hours after administration of spinal anaesthetic ]
    Paresthesia along dermatomal distribution during performing spinal anaesthetic

  7. Grading of palpated landmarks [ Time Frame: Up to 10 minutes fraom start of plapating for landmarks - Completed once anethetist declares that markings are complete ]
    Anesthesiologist palpated the landmarks after positioning and graded the ease of palpation on a 4 point scale (easy, moderate, difficult or impossible)

  8. Peri-procedural VAS scores of pain at injection site [ Time Frame: up to 30 minutes following spinal anaesthetic injection and prior to sedation ]
    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)

  9. peri-procedural discomfort scores [ Time Frame: up to 30 minutes following spinal anaesthetic injection and prior to sedation ]
    peri-procedural discomfort scores measured using an 11 point verbal rating measured (0= no discomfort, 10=most discomfort imaginable).

  10. Level of block [ Time Frame: 15 minutes after spinal anaesthetic injection ]
    Dermatomal level at which loss of cold sensation (ethyl chloride spray) occurs



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189681


Locations
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Ireland
Cork University Hospital
Cork,Ireland, Cork, Ireland
Sponsors and Collaborators
Cork University Hospital
Investigators
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Principal Investigator: Karthikeyan Kallidaikurichi Srinivasan, FCARCSI,MD Cork University Hospital
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Responsible Party: Karthikeyan Kallidaikurichi Srinivasan, Specialist Registrar,Anaesthetics,Cork University Hospital, Cork University Hospital
ClinicalTrials.gov Identifier: NCT02189681    
Other Study ID Numbers: L5S1 study
First Posted: July 14, 2014    Key Record Dates
Last Update Posted: August 28, 2015
Last Verified: August 2015
Keywords provided by Karthikeyan Kallidaikurichi Srinivasan, Cork University Hospital:
spinal anaesthesia
ultrasound
paramedian
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs