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Cochrane Database of Systematic Reviews Protocol - Intervention

Posture and fluids for preventing post‐dural puncture headache

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Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

To assess the effects of posture (bed rest and different positions after a lumbar puncture) and administration of supplementary fluids on preventing post‐dural puncture headache (PDPH) in patients who underwent dural puncture for diagnostic or therapeutic causes.

Background

Description of the condition

Post dural (post lumbar or post spinal) puncture headache (PDPH) is one of the most common complications of diagnostic, therapeutic or inadvertent lumbar punctures (Bezov 2010; Davignon 2002). PDPH is defined as any headache after a lumbar puncture that worsens within 15 minutes of sitting or standing and is relieved within 15 minutes of lying down (IHS 2004). Ninety percent of the PDPHs occur within three days of the procedure and 66% starts in the first 48 hours (Turnbull 2003).

The pathophysiology of PDPH has not been fully described. It is well known that the puncture in the dura allows cerebrospinal fluid (CSF) to leak from the subarachnoid space, resulting in a decrease of CSF volume and pressure (Grande 2005). This CSF volume loss may cause a downward pull on pain‐sensitive structures resulting in a headache (Ahmed 2006; Baumgarten 1987; Davignon 2002; Denny 1987; Harrington 2004). Alternatively, the loss of CSF may cause an increase in blood flow, resulting in arterial and venous vasodilatation and PDPH. A third PDPH explanation involves the role of P substance and the regulation of Neurokinin 1 receptors (NK1R) (Clark 1996).

Occurrence of PDPH varies from 1 to 40%, according to the needle gauge, needle orientation, operator skill level and presence of risk factors such as age group or history of PDPH (Turnbull 2003). This frequency is related to the type of lumbar puncture. During anaesthetic procedures, such as epidural anaesthesia, PDPH is most commonly caused by an unintentional dural puncture (Thew 2008; Turnbull 2003). In contrast to the aforementioned, in diagnostic or therapeutic lumbar punctures, the need for adequate CSF flow requires an intentional lesion that may generate the PDPH phenomenon (Kuczkowski 2006). Estimated frequencies vary from less than 10% following spinal anaesthesia (Hafer 1997; Vallejo 2000), to 36% for diagnostic lumbar punctures (Lavi 2006; Vallejo 2000) and up to 81% in obstetric patients with inadvertent dural puncture during active labour. Reported risk of inadvertent dural puncture placement during epidural anaesthesia in obstetric population, ranges from 0.04% to 6% (Berger 1998; Choi 2003). Therefore, obstetric analgesia is probably the main source of PDPH patients.

The features of PDPH are often variable. PDPH may be accompanied by neck stiffness, tinnitus, hearing loss, photophobia or nausea; other features, such as the location and duration are also unpredictable (Grande 2005). Although PDPH is not a life‐threatening condition, somehow physical activity is often restricted. Likewise patients are usually required to stay in bed the whole day and length of stay in hospital as well as medical attendance increases (Angle 2005).

The variability of symptoms makes PDPH a diagnosis of exclusion. Other alternative diagnoses should be ruled out first e.g. viral meningitis, sinus headache or intracranial haemorrhage (Turnbull 2003). Once PDPH is diagnosed, the initial treatment involves conservative measures such as bed rest and analgesics. If PDPH continues for more than 72 hours, a more specific treatment is indicated (Ahmed 2006). Severe PDPH may respond to some therapeutic drugs and administration of epidural blood patch (Boonmak 2010; Lavi 2006). Two Cochrane reviews are also in process on drug therapy for the prevention and treatment of PDPH (Basurto Ona 2009a; Basurto Ona 2009b).

Description of the intervention

Many publications and reviews of PDPH have focused on treatment once symptoms present. However, the prevention of PDPH is an equally important topic; immobilisation and fluid intake are the two proposed preventive methods that may improve recovery or even prevent PDPH following lumbar puncture.

Sicard first recommended bed rest after a lumbar puncture in 1902. He asserted that patients should rest for 24 hours to prevent PDPH onset (Armon 2005; Coriat 1903). Although the effectiveness of resting is well known for symptom relief, it is debatable whether bed rest prevents the development of symptoms (Davignon 2002). Additionally, there is debate over the appropriate length of bedrest; some authors suggesting that around 4 hours is sufficient, whereas others believe that it should be more than 24 hours (Thoennissen 2001). Aside from the length of rest, it is believed that certain body postures after lumbar puncture, such as a prone position with or without head down tilt may help to prevent PDPH onset.

The effectiveness of fluid intake on PDPH prevention is not well studied. Basic characteristics such as the amount of the fluids and its length have not been established, although some studies suggest that more than five days and three additional litres of fluid to the patient’s current fluid intake is appropriate (Ahmed 2006). Despite the lack of evidence, Vanzetta et al. showed that hydration is a common recommendation for patients after a dural procedure, estimating that 90% of interviewed centres recommend this method to prevent the onset of headache (Vanzetta 2005).

How the intervention might work

Prophylactic resting may have a similar mechanism of action as has been proposed for therapeutic immobilisation after the development of PDPH. CSF leakage is thought to be fundamental in the development of PDPH. Therefore, postures such as a prone position after a lumbar puncture may reduce hydrostatic pressure thereby reducing pressure in the subarachnoid space and allowing a seal to form over the dura, thus enabling CSF leakage repair. As such, this posture may be effective in preventing PDPH onset.

Hydration may work by replacing corporal fluid lost and increasing CSF production (Ahmed 2006). The increase in CSF production would replace lost CSF fluid, preventing a hydrostatic pull on pain‐sensitive structures and vasodilation (Janssens 2003). By this mechanism hydration may prevent the development of PDPH.

Why it is important to do this review

Lumbar puncture is a common clinical practice despite potential adverse effects (Evans 2009; Grande 2005). The morbidity associated with CSF loss, outside of PDPH, includes peripartum seizures, cranial subdural hematomas and subdural fluid collections (Arendt 2009). PDPH may be the first link in a chain of adverse events that are avoidable by following a series of simple recommendations (Janssens 2003). Patient immobilisation and oral intake of fluids may be valuable recommendations to avoid deleterious complications. Even though most cases of PDPH resolve within a few days, a significant number of patients have at least one week of disability, while others require prolonged or recurrent hospitalisations (van Kooten 2008).

A 2002 Cochrane Review related to these preventative strategies was undertaken by Sudlow and Warlow and included published and unpublished literature up to the year 2000 (Sudlow 2002). It is imperative that these results be updated in order to generate relevant and current recommendations for consumers, patients, and health practitioners.

Objectives

To assess the effects of posture (bed rest and different positions after a lumbar puncture) and administration of supplementary fluids on preventing post‐dural puncture headache (PDPH) in patients who underwent dural puncture for diagnostic or therapeutic causes.

Methods

Criteria for considering studies for this review

Types of studies

We will include randomised controlled trials (RCTs) in any clinical/research setting where dural puncture has been used. Quasi‐RCTs will not be included.

Types of participants

All studies with participants of all ages and either gender having undergone lumbar puncture for medical reasons (therapeutic or diagnostic).

Types of interventions

The studies on participants undergoing lumbar puncture must assess one of the following interventions:

  1. A period of bed rest after lumbar puncture alone or in combination with a head‐down tilt strategy, with or without a specific body position, or even a combination of several postural strategies with immobilisation, versus early mobilisation;

  2. Head‐down tilt versus no head‐down tilt in participants who received a period of bed rest;

  3. Prone versus supine posture in participants who received immobilisation;

  4. Administration of supplementary fluids (oral or intravenous) after lumbar puncture versus no/less administration; and

  5. Any combination of the above.

Types of outcome measures

Primary outcomes

We will assess as the primary outcome the presence of PDPH defined as each headache that worsens within 15 minutes after being seated or standing and relieving it within 15 minutes after lying (IHS 2004). We will use the valid PDPH diagnosis criteria specified by the International Headache Society (IHS) (IHS 2004) in accordance with the article publication date.

Secondary outcomes

We will assess the presence of severe PDPH using the study definition of severity based on specific features (for example, duration of PDPH), a visual analogue score (VAS) or other criteria such as the need of specialized treatments to relieve the headache (for instance, epidural blood patch). Likewise we will assess information about any headache subsequent to the lumbar puncture procedure in order to incorporate any possible data about PDPH not catalogued as one.

Search methods for identification of studies

Electronic searches

The Cochrane Central Register of Controlled Trials (CENTRAL) will be used as our primary source in order to identify all relevant studies. We will use a modified version of the CENTRAL search for searching MEDLINE, EMBASE and LILACS. The search terms are a combination of thesaurus‐based and free‐text terms, both the intervention (lumbar puncture in neurological, anaesthesia or myelography settings) and headache. There will be no language restriction.

See Appendix 1 for details of the CENTRAL search strategy, for the full review this search will be adapted for the other databases.

Searching other resources

We will search reference lists from retrieved studies, information from clinical trial registration websites and contact study authors for unpublished studies and missing data.

Data collection and analysis

Selection of studies

Two review authors (IA and LM) will select the studies for eligibility independently. The review authors will review titles and abstracts of all identified studies which fulfil the inclusion criteria. Full text of the selected studies will be retrieved to confirm their relevance for inclusion. Any disagreement will be solved through discussion with a third review author (AC). Review authors will not be blinded to the authors’ names and institutions, journal of publication, or study results at any stage of the review.

Data extraction and management

Two review authors (RQ and LM) will use pre‐designed/tested data forms to extract information from the original study reports about participants, methods of randomisation, blinding, comparison of interest, number of participants originally randomised by arm, follow‐up losses and outcomes. Reasons for exclusion of potential studies will be recorded in the 'Characteristics of excluded studies' table. Any disagreement will be clarified by discussion with a third review author (IA). Extracted data will be entered into Review Manager 5.1 for further analyses.

Assessment of risk of bias in included studies

Risk of bias in included studies will be assessed independently by two review authors (IA and AC) using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2009). Five domains (Sequence generation, allocation concealment, blinding in outcomes assessment, incomplete outcome data and selective reporting bias) will be taken into consideration in this assessment and each one will be classified as present, not present or unclear. Any disagreement will be resolved by discussion or by involving a third review author (XB).

Measures of treatment effect

We will present results as summary risk ratio (RR) with 95% confidence intervals (CIs) and numbers needed to treat to benefit (NNT) as absolute measure of benefit or harm. NNT shall be calculated as the reciprocal of Risk differences (RD) (McQuay 1998). Odds ratios (OR) calculated using the Peto O‐E method will also be analysed.

Dealing with missing data

For included studies, we will note levels of attrition. We will explore the impact of including studies with high levels of missing data in the overall assessment of treatment effect by using sensitivity analysis. For all outcomes we will carry out analyses, as far as possible, on an intention‐to‐treat (ITT) basis, i.e. we will attempt to include all participants randomised to each group in the analyses. We will assume that any participant lost to follow‐up had not experienced the outcome being considered.

Assessment of heterogeneity

Heterogeneity of effect sizes will be assessed by means of the I2 statistic and defined as I2 greater than 30%.

Data synthesis

We will carry out statistical analysis using the Cochrane RevMan 5.1 software. If homogeneity of effects sizes is detected (I2 < 30%), we will combine data in a fixed‐effect model for planned analyses. For I2 from 30% to 60%, a random‐effects model will be used after a full assessment of clinical similarity among the studies to combine (Higgins 2003). If clinical heterogeneity is present we will not combine the studies.

Subgroup analysis and investigation of heterogeneity

If the included studies provide the necessary data, we will assess the following subgroup analyses:

  1. Participants undergoing dural puncture for anaesthesia only, diagnosis only, or myelography only.

  2. Subgroup analysis for gender.

  3. Subgroup analysis for age.

  4. Subgroup analysis for posture during the lumbar puncture (e.g. lateral or sitting up).

  5. Subgroup analysis for needle gauge (e.g. 22, 29, among others).

  6. Subgroup analysis for needle tips (e.g. pencil‐point, diamond, double bevel, among others).

  7. Subgroup analysis for amount of CSF aspirated.

Sensitivity analysis

Any sensitivity analyses will include assessment of the effect on the primary outcome by excluding any study with high risk of bias in one of the following:

  1. allocation features;

  2. levels of missing data; and

  3. blinding of outcome assessment.

Likewise, we shall assess the effect of analysing the data on an ITT basis versus not, as well as the impact of the random‐effects model or the effect measure in data synthesis.