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

Kim 2011.

Methods

  • Design: parallel‐group (2 arms)

  • Country: Korea

  • Multisite: no

  • Needle tip used: diamond

  • Needle diameter used: 23 vs 25

  • Number of attempts: first (60% vs 40%)

  • Procedure: anaesthesia

  • Site of the puncture: L3‐4 or L4‐5

  • Training level of those who administered the puncture: experienced nurse

  • Median or paramedian technique: midline approach

  • Type of anaesthetic: 0.5% bupivacaine hydrochloride or 1% tetracaine with 0.1 mg to 0.2 mg epinephrine

  • Patient position: lateral position
Participants 1. 53 patients who underwent elective orthopaedic knee or hip surgery under spinal anaesthesia were enrolled (age > 60 years, ASA classes I–II, recumbent in bed for the first 24 hours postoperatively, and administration of intravenous patient‐controlled analgesia for the first 48 hours postoperatively)
Exclusion criteria: history of migraine headache, previous history of PDPH, cardiovascular or central nervous disease, and coagulation abnormality
Patients were randomized to:

  • 23 G Quincke group: 26 (49%)

  • 25 G Quincke group: 27 (51%)


2. 3 patients (5.66%) were excluded due to severe hypotension, heart problems after operation or refusal to participate in follow‐up
Patients analysed:

  • 23 G Quincke group: 25

  • 25 G Quincke group: 25


3. Main characteristics of patients:

  • Age (mean, SD): 23 G Quincke group: 68.2, 6.3; 25 G Quincke group: 68.5, 6.9

  • Height (mean, SD): 23 G Quincke group: 158.6, 7.3; 25 G Quincke group: 159.5, 7.9

  • Weight (mean, SD): 23 G Quincke group: 57.7, 7.6; 25 G Quincke group: 60.8, 8.5

  • Gender ‐ male (number): 23 G Quincke group: 9; 25 G Quincke group: 10
Interventions

  1. 23 G Quincke needles (Hakko, Chikuma, Japan). Bevel parallel to the longitudinal dural fibre.

  2. 25 G Quincke needles (Hakko, Chikuma, Japan). Bevel parallel to the longitudinal dural fibre.

  3. Co‐intervention: recumbent in bed for the first 24 hours postoperatively.
Outcomes Outcomes were not classified as primary or secondary

  1. PDPH

  2. Severity of PDPH

  3. Back pain

  4. Number of attempted lumbar punctures
Notes

  1. Trial registration: not stated

  2. Funder: none

  3. Role of funder: not stated

  4. A priori sample size estimation: yes

  5. Conducted: December 2006 to October 2007

  6. Declared conflicts of interest: yes (none declared)
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: "The 53 patients were randomly allocated to either the experimental group (…)" (page 1316)
Allocation concealment (selection bias) Unclear risk Insufficient information to score this item as low or high risk of bias
Blinding of participants (performance bias) Low risk Quote: "The patients were blinded to the intervention allocations. In addition, research assistants who were working as a nurse on the orthopedic nursing unit and measured postdural puncture headache and post‐operative back pain, were blinded to the intervention allocations (…)" (page 1316)
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "The patients were blinded to the intervention allocations. In addition, research assistants who were working as a nurse on the orthopedic nursing unit and measured postdural puncture headache and post‐operative back pain, were blinded to the intervention allocations (…)" (page 1316)
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 5.66% of patients were lost to follow‐up
Selective reporting (reporting bias) High risk Adverse events, additional to PDPH, were not reported
Other bias Low risk No other biases were identified