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. 2017 Apr 7;2017(4):CD010807. doi: 10.1002/14651858.CD010807.pub2

Kuusniemi 2013.

Methods
  • Design: parallel‐group (2 arms)

  • Country: Finland

  • Multisite: no

  • International: no

  • Needle type design used: Quincke vs Whitacre

  • Needle diameter used: 27

  • Procedure: anaesthesia

  • Number of attempts (first): 25 vs 24

  • Site of the puncture: L2‐3

  • Training level of those who administered the puncture: unknown

  • Median or paramedian technique: midline approach

  • Type of anaesthesia: 0.5% plain bupivacaine

  • Patient position: lateral position

Participants 1. 60 consecutive outpatients (ASA) physical status I–III, ages ranging between 18 and 60 years, scheduled for unilateral lower limb surgery, with spinal block being used as the sole anaesthetic without any intraoperative sedation were enrolled
Exclusion criteria: previous history of intolerance to the study drug or related compounds and existing contraindications for spinal anaesthesia, patients with a body mass index (BMI) of 30 kg/m2, those with a history of alcoholism, drug abuse, or psychological or other emotional problems, patients who were pregnant or lactating
Patients randomized to:
  • Quincke group: 30 patients (50%)

  • Whitacre group: 30 patients (50%)


2. No patients were excluded from analysis
3. Main characteristics of patients:
  • Age (mean, SD): Quincke group: 45, 9.1; Whitacre group: 42, 11.4

  • Men (number): Quincke group: 8; Whitacre group: 11

  • Weight (mean, SD): Quincke group: 70, 11.6; Whitacre group: 70, 11.2

Interventions
  • 27 G Quincke: Yale/Becton–Dickinson

  • 27 G Whitacre group: Becton–Dickinson


In both groups a 20 G introducer was applied
Outcomes Primary outcome:
  1. Spread of spinal anaesthesia


Secondary outcomes:
  1. Patient satisfaction

  2. Adverse effects: headache, PDPH, backache

Notes
  1. Trial registration: not stated

  2. Funder: not stated

  3. Role of funder: not stated

  4. A priori sample size estimation: yes

  5. Conducted: not stated

  6. Declared conflicts of interest: yes (page 230)

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to score this item as low or high risk of bias. Quote: "using a sealed envelope technique, the patients were randomized to two groups". (page 225)
Allocation concealment (selection bias) Low risk Quote: "using a sealed envelope technique, the patients were randomized to two groups" (page 225)
Blinding of participants (performance bias) Low risk Quote: "patients, nurses, and the anesthetist performing the motor and sensory block assessments were blinded for the spinal needle type used". (page 225)
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to score this item as low or high risk of bias
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No patients were lost to follow‐up
Selective reporting (reporting bias) Low risk All patient‐important outcomes were reported
Other bias Low risk No other biases were identified