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Post-Dural Puncture Headache clinical trials

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NCT ID: NCT02727244 Completed - Pain Clinical Trials

The Association Between Pain Catastrophizing Scale Score and Postspinal Headache

Start date: April 15, 2016
Phase:
Study type: Observational

This study is aimed to elucidate the association between Pain Catastrophizing Scale Score and Postspinal Headache in Patients Underwent Cesarean Section With Spinal Anesthesia.

NCT ID: NCT02522013 Completed - Clinical trials for Post-dural Puncture Headache

Aminophylline for Patients With Post-Dural Puncture Headache

Start date: October 2015
Phase: Phase 3
Study type: Interventional

Post-dural puncture headache (PDPH) is the most common complication of lumbar puncture. Its clinical manifestations are pain in the forehead and the occipital region, or diffuse headache. The pain is dull or fluctuating, becoming worse when standing and better when lying down, and is often accompanied by symptoms including a stiff neck, tinnitus, hearing loss, photophobia, and nausea, which cause great suffering to the patients1. According to epidemiological data, approximately 10% to 30% of the patients who undergo lumbar puncture suffer from PDPH within 48 hours of the procedure.Currently, commonly used treatments for PDPH include rehydration, the administration of corticotropin, caffeine, or sumatriptan, and the application of an epidural blood patch. The efficacy of theophylline has been proven in a placebo-controlled study in which 17 PDPH patients received an intravenous (IV) injection of 200 mg theophylline. The Visual Analogic Scale scores 4 hours after treatment were significantly different compared with those of the placebo group5. At present, the clinical application of theophylline has been replaced by aminophylline and doxofylline, and it is difficult to purchase theophylline in most hospitals in China and other countries. The Aminophylline for Patients With Post-Dural Puncture Headache trial, is a prospective,randomized,double-blind,placebo-controlled trial to evaluate the efficacy and safety of an IV injection of aminophylline on post-dural puncture headache.Eligible patients were randomized in a blinded fashion(1:1) to receive IV injection of aminophyllineor or sterile isotonic saline.The investigators estimate that this trial will demonstrate that an IV injection of aminophylline could be the preferred method for the clinical treatment of PDPH.

NCT ID: NCT02517931 Withdrawn - Clinical trials for Postdural Puncture Headache

Sphenopalatine Ganglion Block for Postdural Puncture Headache in the Emergency Department

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

This study evaluates sphenopalatine ganglion block (SPGB) for the treatment of postdural puncture headache (PDPH) in the emergency department (ED). Half of the patients will receive a true nerve block with lidocaine and bupivacaine. The other half will receive a placebo nerve block.

NCT ID: NCT02473276 Suspended - Clinical trials for Postdural Puncture Headache

2 Dose Neuraxial Morphine for Prevention of PDPH

Start date: September 2015
Phase: Phase 4
Study type: Interventional

Neuraxial analgesia (most commonly continuous epidural or combined spinal epidural) is the most effective modality available for pain relief during labor. Accidental dural puncture (ADP) with a large bore epidural needle and the resulting post-dural puncture headache (PDPH) is one of the most significant sources of anesthesia-related morbidity in parturients. Epidural blood patch (EBP) is the gold standard for treatment of PDPH, and although almost always effective, can result in another ADP, as well as low back pain and lower extremity pain. For this reason, effective measures to prevent PDPH when ADP occurs would be highly valuable. One small study in which 50 women were randomly allocated to receive 2 epidural injections of morphine or saline, demonstrated a beneficial effect of epidural morphine in decreasing the incidence of PDPH. This study aims to determine the efficacy of 2 doses of neuraxial (either epidural (EPID) or intrathecal) preservative-free morphine (PFM) to prevent headache after ADP in parturients.

NCT ID: NCT02427009 Terminated - Clinical trials for Post-Dural Puncture Headache

Maintaining a Prone Position After Use of an Epidural Blood Patch for the Treatment of Post-dural Puncture Headache

UpSideDown
Start date: December 2015
Phase: N/A
Study type: Interventional

The main objective of this study is to assess the rate of recurrence of headache following a first blood patch where patients will be positioned in the prone position for an hour after each blood patch needed during this study.

NCT ID: NCT02394457 Completed - Clinical trials for Postdural Puncture Headache

Cosyntropin Versus Epidural Blood Patch (EBP) for Treatment of Treatment of Post Dural Puncture Headache

PDPH
Start date: August 2010
Phase: Phase 4
Study type: Interventional

PDPH is a common problem after either intentional or unintentional Dural puncture. It is especially common in young female patients and in patients undergoing Lumbar Puncture using the typical kit containing large 20 gauge needles (1). Hypothesis is that Cosyntropin therapy is at least as effective as current conservative therapy (caffeine/fluid) and/or Epidural Blood Patch. Patients will be randomly assigned to undergo either: (1) EBP with IVF therapy or (2)Cosyntropin IV with IVF therapy. Endpoints will be a pain score that is given prior to the procedure, Emergency Department (ED) discharge pain score and post procedural day (PPD) day 1, day 3 and day 7 pain and functional levels. Patients in Cosyntropin arm of the study may request crossover to EBP at anytime after a 24 hour assessment period is completed per Standard of Care for treatment of PDPH, in order to ensure no undue distress is placed on the patient in order to complete this study. Current treatments consist primarily of non-invasive treatment with intravenous fluids and caffeine therapy and invasive treatment by Epidural Blood Patch. Efficacy of Caffeine 300mg IV BID x 1d doses is approximately 70% (2). However this therapy has been linked to post-treatment seizures. EBP was originally thought to be 90% effective with repeat treatment efficacy approaching >96%. However more recent studies by Taivainen et al (3) have shown only a 61% rate of permanent cure. Additionally, EBP are contraindicated in patients with signs of increased intra-cranial pressure (ICP), coagulation issues, signs/symptoms of Central Nervous System (CNS) /systemic infection or local infection at the site of the EBP, thus resulting in decreased utility. Complications are also quite serious ranging from meningitis, spinal hematoma, repeat dural puncture, localized infection and vagal response to the procedure. EBP are not typically performed until after conservative measures have failed which leads to further prolongation of the patients decreased functional status and pain. Additionally, the cost of both treatments is substantial considering prolonged ED visits for conservative treatments often followed by the time and expense of an EBP. The goal of this investigation is to aid in the confirmation of case reports advocating the economy, efficacy and safety of synthetic Adrenal CorticTropin Hormone (ACTH) as a treatment of PDPH (4,5,6,7,8,9).

NCT ID: NCT02384031 Completed - Clinical trials for Post-dural Puncture Headache

Post-dural Puncture Headache - Needles and Biomarkers in CSF

Start date: February 2012
Phase: N/A
Study type: Interventional

Post-dural puncture headache (PDPH) is the most common complication following lumbar puncture (LP). The frequency varies widely depending on a number of factors, among which patient characteristics, case ascertainment, gauge and type of needle used are of significant importance. In 2001, Strupp et al. showed that over 12 % of 115 patients who were subjected to diagnostic lumbar puncture with a 22 gg (0.7 mm) atraumatic needle suffered post-dural puncture headache, while over 24 % of 115 who were given a lumbar puncture with a 22 gg traumatic needle suffered a headache. This finding provided the basis for an American recommendation to use a 22 gg atraumatic needle for diagnostic lumbar puncture. A later study with 58 patients has shown an even greater difference (36 % versus 3 % post-dural puncture headache) when an atraumatic needle is used. Despite these findings, European Neurologist continue to hold on to the cutting needle. Here the investigators propose a prospective randomized study design with double masking; neither patient nor evaluator of PDPH aware of the needle design used, and with an active ascertainment of the occurrence of PDPH in accordance with updated headache classification guidelines. The investigators also intend to investigate whether specific neuroinflammatory substances and metabolites (different outcome variables) in the cerebrospinal fluid (CSF) will affect the explanatory variable.

NCT ID: NCT02365909 Terminated - Clinical trials for Postdural Puncture Headache

Study Evaluating Sphenopalatine Ganglion Block (SPGB) for Treatment of Postdural Puncture Headache (PDPH)

PDPH
Start date: June 29, 2015
Phase: Early Phase 1
Study type: Interventional

Postdural puncture headaches (PDPH) are a consequence of spinal and epidural anesthesia in approximately 1% of cases when performed in obstetric patients. The gold standard treatment for a PDPH is currently an epidural blood patch (EBP), which involves placing a needle back into the epidural space of the neuraxium and then injecting 20 ml of the patient's own blood through the needle and into the epidural space to form a clot over the insult in the tissue layer that causes the headaches. The investigators want to test the efficacy of using a less invasive procedure, called a sphenopalatine block (SPGB), for treatment of PDPH. SPGB has been used for many years in the treatment of migraines and cluster headaches, and there are several case reports of its use to successfully treat PDPH as well. SPGB simply involves applying a local anesthetic to the mucosa in the back of each nostril to numb the nerves that cause the headache. The investigators hope that the SPGB will reduce the number of PDPH patients that require and EBP.

NCT ID: NCT02362828 Completed - Clinical trials for Post-Dural Puncture Headache

EPiMAP Obstetrics: European Practices in the Management of Accidental Dural Puncture in Obstetrics

EPiMAP
Start date: January 2016
Phase:
Study type: Observational

The aims of EPiMAP Obstetrics are: - to identify risk factors for failure of epidural blood patch in the obstetric population for management of post dural puncture headache. - to describe European practices in the management of accidental dural puncture in the Obstetric population.

NCT ID: NCT02181205 Withdrawn - Clinical trials for Postdural Puncture Headache

Sphenopalatine Ganglion Block for Post-Dural Puncture Headache

Start date: November 2014
Phase: N/A
Study type: Interventional

The investigators are attempting to determine a less invasive method of treatment for postdural puncture headaches that can occur after regional anesthesia. The investigators will be evaluating the relief of headache with those subjects receiving treatment with a sphenopalatine ganglion block with bupivacaine versus placebo, evaluating the incidence of epidural blood patch, pain score of headache at 1 hour, then 24, 48, and 72 hours lower with post study treatment versus placebo, and potential side effects of those patients receiving study therapy as well as epidural blood patch.