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

Shaikh 2008.

Methods

  • Design: parallel‐group(3 arms)

  • Country: India

  • Multisite: no

  • Needle tip used: 25 G Quincke vs 27 G Quincke vs 27 G Whitacre

  • Needle diameter used: 25 vs 27

  • Number of attempts: 1

  • Procedure: anaesthesia

  • Site of the puncture: L3‐4

  • Training level of those who administered the puncture: unknown

  • Median or paramedian technique: unknown

  • Type of anaesthesia: 1.5 ml to 2.0 ml 0.75% hyperbaric bupivacaine

  • Patient position: sitting position
Participants 1. 480 American Society of Anesthesiologists physical status classification (ASA) I‐II women, aged 18 to 45 years, undergoing elective caesarean section, were enrolled
Exclusion criteria: patient refusal, contraindication to spinal anaesthesia for infectious haemodynamic, haemostatic or neurological reasons, emergency caesarean section, severe pre‐eclampsia or failure of the spinal anaesthesia. Patients with more than one attempt were excluded from the study.
Patients randomized to:

  • 25 G Quincke group: 168 patients (35%)

  • 27 G Quincke group: 160 patients (33%)

  • 27 G Whitacre group: 152 patients (32%)


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

  • Age (mean, SD): 25 G Quincke group: 25.8, 5.6; 27 G Quincke group: 26.4, 5.86; 27 G Whitacre group: 26.7, 4.45

  • Weight (mean, SD): 25 G Quincke group: 59.9, 8.37; 27 G Quincke group: 61.7, 8.45; 27 G Whitacre group: 63, 9.10
Interventions

  1. 25 G Quincke (group I). No further information was provided. The bevel of the Quincke spinal needles (group I and II) was kept parallel to the sagittal plane to prevent cutting of the dural fibres.

  2. 27 G Quincke (group II). No further information was provided. The bevel of the Quincke spinal needles (group I and II) was kept parallel to the sagittal plane to prevent cutting of the dural fibres.

  3. 27 G Whitacre (group III). No further information was provided.
Outcomes Outcomes were not classified as primary or secondary.

  1. PDPH

  2. Non‐specific headaches

  3. Severity of PDPH
Notes

  1. Trial registration: not stated

  2. Funder: not stated

  3. Role of funder: not stated

  4. A priori sample size estimation: no

  5. Conducted: October 2005 to December 2006

  6. Declared conflicts of interest: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The patients were selected randomly by balloting." (page 10)
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: "Patient, surgeon and the assessor in the ward did not know which spinal needle was used." (page 10)
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "Postoperatively, all patients were assessed daily for 4‐days by an investigator, blinded to the type and size of the needle used.." (page 11)
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No 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