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

De Andres 1999.

Methods

  • Design: parallel‐group (2 arms)

  • Country: Spain

  • Multisite: no

  • International: no

  • Needle type design used: Atraucan 26 vs Whitacre 27

  • Needle diameter used: 26 vs 27

  • Procedure: subarachnoid anaesthesia

  • Number of attempts: 1.4 vs 1.5 attempts

  • Site of the puncture: unknown

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

  • Median or paramedian technique: midline approach

  • Type of anaesthesia: 3 mL of 0.5% bupivacaine

  • Patient position: lateral position
Participants 1. 158 patients enrolled during a 12‐month period (ASA I and II, aged from 20 to 40 years, undergoing lower limb orthopaedic surgery)
Exclusion criteria: presence of hypovolaemia, coagulation disorders, infection at the puncture site, use of general anaesthesia, history of headaches, chronic back pain or pregnancy
Patients randomized to:

  • 26 G Atraucan group: 79 patients (%)

  • 27 G Whitacre group: 79 patients (%)


2. No patients were excluded from further analysis
3. Main characteristics of patients:

  • Age (mean, SD): Atraucan group: 26.8, 7.2; Whitacre group: 27.4, 7.8

  • Weight (mean, SD): Atraucan group: 75.8, 18.4; Whitacre group: 77.4, 18.5

  • Height (mean, SD): Atraucan group: 168, 18.8; Whitacre group: 172, 13.6
Interventions

  • 26 G Atraucan: B. Braun Medical, Melsungen Germany

  • 27 G Whitacre group: Becton Dickinson, Madrid, Spain
Outcomes Outcomes were not classified as primary or secondary

  1. Technical parameters

  2. Quality of analgesia

  3. Headache (nonspecific, PDPH)

  4. Headache associated symptoms

  5. Other postoperative side effects
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: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "On arrival at the operating room, the patients were assigned to one of two groups using a randomization table: (…)." (page 548)
Allocation concealment (selection bias) Unclear risk Insufficient information to score this item as low or high risk of bias
Blinding of participants (performance bias) Unclear risk Insufficient information to score this item as low or high risk of bias
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "After surgery, close follow‐up of patients was performed by an investigator blinded to the study protocol". (page 549)
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No patients were lost to follow‐up
Selective reporting (reporting bias) Unclear risk Information about non‐specific headaches is unclear
Other bias Low risk No other biases were identified