title: Needle gauge and tip designs for preventing post-dural puncture headache (PDPH).
abstract: BACKGROUND
  Post-dural puncture headache (PDPH) is one of the most common complications of diagnostic and therapeutic lumbar punctures. PDPH is defined as any headache occurring after a lumbar puncture that worsens within 15 minutes of sitting or standing and is relieved within 15 minutes of the patient lying down. Researchers have suggested many types of interventions to help prevent PDPH. It has been suggested that aspects such as needle tip and gauge can be modified to decrease the incidence of PDPH.
  
  
  OBJECTIVE
  To assess the effects of needle tip design (traumatic versus atraumatic) and diameter (gauge) on the prevention of PDPH in participants who have undergone dural puncture for diagnostic or therapeutic causes.
  
  
  METHODS
  We searched CENTRAL, MEDLINE, Embase, CINAHL and LILACS, as well as trial registries via the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) search portal in September 2016. We adopted the MEDLINE strategy for searching the other databases. The search terms we used were a combination of thesaurus-based and free-text terms for both interventions (lumbar puncture in neurological, anaesthesia or myelography settings) and headache.
  
  
  METHODS
  We included randomized controlled trials (RCTs) conducted in any clinical/research setting where dural puncture had been used in participants of all ages and both genders, which compared different tip designs or diameters for prevention of PDPH DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by Cochrane.
  
  
  RESULTS
  We included 70 studies in the review; 66 studies with 17,067 participants were included in the quantitative analysis. An additional 18 studies are awaiting classification and 12 are ongoing. Fifteen of the 18 studies awaiting classification mainly correspond to congress summaries published before 2010, in which the available information does not allow the complete evaluation of all their risks of bias and characteristics. Our main outcome was prevention of PDPH, but we also assessed the onset of severe PDPH, headache in general and adverse events. The quality of evidence was moderate for most of the outcomes mainly due to risk of bias issues. For the analysis, we undertook three main comparisons: 1) traumatic needles versus atraumatic needles; 2) larger gauge traumatic needles versus smaller gauge traumatic needles; and 3) larger gauge atraumatic needles versus smaller gauge atraumatic needles. For each main comparison, if data were available, we performed a subgroup analysis evaluating lumbar puncture indication, age and posture.For the first comparison, the use of traumatic needles showed a higher risk of onset of PDPH compared to atraumatic needles (36 studies, 9378 participants, risk ratio (RR) 2.14, 95% confidence interval (CI) 1.72 to 2.67, I2= 9%).In the second comparison of traumatic needles, studies comparing various sizes of large and small gauges showed no significant difference in effects in terms of risk of PDPH, with the exception of one study comparing 26 and 27 gauge needles (one study, 658 participants, RR 6.47, 95% CI 2.55 to 16.43).In the third comparison of atraumatic needles, studies comparing various sizes of large and small gauges showed no significant difference in effects in terms of risk of PDPH.We observed no significant difference in the risk of paraesthesia, backache, severe PDPH and any headache between traumatic and atraumatic needles. Sensitivity analyses of PDPH results between traumatic and atraumatic needles omitting high risk of bias studies showed similar results regarding the benefit of atraumatic needles in the prevention of PDPH (three studies, RR 2.78, 95% CI 1.26 to 6.15; I2= 51%).
  
  
  CONCLUSIONS
  There is moderate-quality evidence that atraumatic needles reduce the risk of post-dural puncture headache (PDPH) without increasing adverse events such as paraesthesia or backache. The studies did not report very clearly on aspects related to randomization, such as random sequence generation and allocation concealment, making it difficult to interpret the risk of bias in the included studies. The moderate quality of the evidence for traumatic versus atraumatic needles suggests that further research is likely to have an important impact on our confidence in the estimate of effect.
authors.affiliation: Cochrane Ecuador. Centro de Investigación en Salud Pública y Epidemiología Clínica (CISPEC). Facultad de Ciencias de la Salud Eugenio Espejo, Universidad Tecnológica Equinoccial, Quito, Ecuador.|Division of Research, Fundación Universitaria de Ciencias de la Salud, Bogotá D.C., Colombia.
authors.forename: Ingrid
authors.initials: I
authors.lastname: Arevalo-Rodriguez
authors.affiliation: Department of Anaesthesia, Hospital de San José, Fundación Universitaria de Ciencias de la Salud, 10th Street No 18-75, Bogotá D.C., Colombia.
authors.forename: Luis
authors.initials: L
authors.lastname: Muñoz
authors.affiliation: Division of Research, Fundación Universitaria de Ciencias de la Salud - Hospital de San José/Hospital Infantil de San José, Bogotá, Colombia.
authors.forename: Natalia
authors.initials: N
authors.lastname: Godoy-Casasbuenas
authors.affiliation: Argentine Cochrane Centre, Institute for Clinical Effectiveness and Health Policy (IECS-CONICET), Dr. Emilio Ravignani 2024, Buenos Aires, Capital Federal, Argentina, C1414CPV.
authors.forename: Agustín
authors.initials: A
authors.lastname: Ciapponi
authors.affiliation: Department of Anaesthesia, Hospital de San José, Fundación Universitaria de Ciencias de la Salud, 10th Street No 18-75, Bogotá D.C., Colombia.|Department of Anesthesiology, VU University Medical Center, Amsterdam, Netherlands.
authors.forename: Jimmy J
authors.initials: JJ
authors.lastname: Arevalo
authors.affiliation: Department of Anesthesiology, VU University Medical Center, Amsterdam, Netherlands.
authors.forename: Sabine
authors.initials: S
authors.lastname: Boogaard
authors.affiliation: Iberoamerican Cochrane Centre - Biomedical Research Institute Sant Pau (IIB Sant Pau), CIBER Epidemiología y Salud Pública (CIBERESP), Sant Antoni Maria Claret 171, Edifici Casa de Convalescència, Barcelona, Catalunya, Spain, 08041.
authors.forename: Marta
authors.initials: M
authors.lastname: Roqué I Figuls
mesh_terms: D001416:Back Pain / Q000453:epidemiology / Q000209:etiology; D004867:Equipment Design; D006261:Headache / Q000453:epidemiology / Q000209:etiology; D006801:Humans; D009339:Needles; D010292:Paresthesia / Q000453:epidemiology / Q000209:etiology; D051299:Post-Dural Puncture Headache / Q000453:epidemiology / Q000517:prevention & control*; D016032:Randomized Controlled Trials as Topic; D012680:Sensitivity and Specificity; D013129:Spinal Puncture / Q000009:adverse effects* / Q000295:instrumentation