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临床试验/NCT02189681
NCT02189681已完成不适用

Comparison of Conventional Landmark Guided Midline (Group C) Versus Pre-procedural Ultrasound Guided Paramedian at L5S1 (Group P) Technique for Spinal Anaesthesia

Cork University Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
difference in number of passes between the two groups.

研究概览

简要总结

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.

详细描述

This will be a prospective, randomised, controlled study. All consented patients scheduled to undergo elective total knee or total hip arthroplasty under spinal anesthesia will be included in the study. A written informed consent will be obtained from all patients participating in the study. Patients with contraindications to spinal anesthesia (allergy to local anesthetic, coagulopathy, local infection and indeterminate neurological disease) will be excluded from the study.

The patients will be randomised using random number generating software (Research Randomizer Version 4.0 ) to undergo either conventional landmark-guided spinal anesthesia (Group C) or pre-procedural ultrasound-guided paramedian L5S1 spinal (Group P). Group allocation will be concealed by enclosing the codes in a sealed opaque envelope and will be seen by the attending anesthesiologist immediately before performing the procedure. Patients will be blinded as to their allocated study group.

In both groups, spinal anesthesia will be performed by one of three consultant anesthesiologists (FL, PL, GI), each having performed more than 75 neuraxial ultrasound scans prior to the study. On arrival to the anesthesia induction room baseline monitoring (non-invasive blood pressure, pulse oximetry and 3 lead ECG) and intravenous access will be established. The patients will be then positioned sitting on a level trolley with feet resting on a foot rest. They will be given a pillow to hug and requested to maintain an arched back posture with an assistant holding the patient to aid positioning.

In group C, the anesthesiologist will palpate the landmarks after positioning and graded the ease of palpation on a 4 point scale (easy, moderate, difficult or impossible) as described in previous studies.10 Strict asepsis will be followed throughout the procedure with anesthesiologist scrubbed prior to procedure, wearing mask and sterile gloves. The skin will be prepped with 2% Chlorhexidine (Chloraprep 3 ml applicator, CareFusion Corporation, San Diego, CA 92130,USA) following which 2-5 ml of 1% lidocaine will be used to infiltrate the skin. The anesthesiologist performing the spinal technique will be allowed to choose the appropriate needle length ( 90 or 119 mm 25 G Whitacre needle, Becton, Dickinson and Company, Franklin Lakes, New Jersey, 07417-1880, USA), gauge (25 or 22G), depth and angle of insertion. Hyperbaric bupivacaine will be used in both groups. After completion of spinal anesthetic injection, and positioning the patient in lateral decubitus, ultrasound will be used to identify the interspinous level at which the injection will be administered.

In group P, a portable ultrasound unit with a curved 2-5 MHz probe will be used for initial pre-procedural marking. A paramedian sagittal oblique view of the neuraxis will be obtained and the sacrum will be identified, following which the interlaminar space between L5 and S1 will be noted. At this interspace with the probe positioned to obtain the clearest ultrasound image of the anterior complex (ligamentum flavum dura complex- LFD) and posterior complex (posterior longitudinal ligament- PLL) possible, a skin marker will be used to mark the midpoint of the long border of the probe and the midpoints of the short borders of the probe. The medial angulation of the probe will also be noted to guide the insertion of the spinal needle. 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 will be used as paramedian insertion point for the spinal needle. A transverse median (TM) view at the same level will also be obtained and the midline will be marked. This marking will be used to aid the medial angulation of the spinal needle. Both PSO and TM views would be graded as good (both LFD and PLL visible), intermediate (either LFD or PLL visible) and poor (both LFD and PLL not visible).15 Following skin marking, care will be taken to make sure that the needle entry site will be free of ultrasound gel prior to needle insertion. In group P, the anesthesiologist will not palpate the landmarks for grading until the spinal injection is complete. Spinal anesthesia will be performed in the same aseptic manner as mentioned earlier.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

difference in number of passes between the two groups.

时间窗: 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)

次要结局

  • Level of block(15 minutes after spinal anaesthetic injection)
  • Blood in spinal needle(Up to 45 minutes from the start of insertion of spinal needled for administration of spinal anaesthetic)
  • Number of spinal needle insertion attempts(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)
  • Presence of paresthesia(Up to 24 hours after administration of spinal anaesthetic)
  • Grading of palpated landmarks(Up to 10 minutes fraom start of plapating for landmarks - Completed once anethetist declares that markings are complete)
  • Peri-procedural VAS scores of pain at injection site(up to 30 minutes following spinal anaesthetic injection and prior to sedation)
  • 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)
  • peri-procedural discomfort scores(up to 30 minutes following spinal anaesthetic injection and prior to sedation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karthikeyan Kallidaikurichi Srinivasan

Specialist Registrar,Anaesthetics,Cork University Hospital

Cork University Hospital

研究点 (1)

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