scholarly journals Evaluation of the effectiveness and tolerance of tetracosactide in the treatment of post-dural puncture headaches (ESYBRECHE): a study protocol for a randomised controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Célia Depaulis ◽  
Nadia Steer ◽  
Léa Garessus ◽  
Dominique Chassard ◽  
Frédéric Aubrun
Keyword(s):  
Dural Puncture ◽  
Epidural Blood Patch ◽  
Controlled Trial ◽  
Synthetic Analogue ◽  
General Activity ◽  
Therapeutic Success ◽  
Double Blind ◽  
Activity Increase ◽  
Neuraxial Anaesthesia ◽  
Blood Patch

Abstract Background Post-dural puncture headache (PDPH) is one of the most common complications of neuraxial anaesthesia. It limits patients’ general activity and increases the length of hospital stays and the use of care. It is particularly disabling during the postpartum period, when mothers have to take care of their child. Epidural blood patch is the standard treatment for PDPH. However, it is an invasive procedure that may result in rare but serious complications. Recent evidence has suggested that adrenocorticotropic hormone (ACTH) is effective in the management of PDPH. The aim of this study is to assess the efficacy and safety of tetracosactide (Synacthen®), a synthetic analogue of ACTH, for PDPH treatment in patients who receive neuraxial anaesthesia during labour. Methods This randomised, double-blind, placebo-controlled, parallel-arm trial, is performed in two French university hospitals. Eligible patients are those suffering from postpartum PDPH, who are randomised to receive either 1 mg of tetracosactide intravenously over 20 min or to 0.9% saline (placebo). The primary endpoint is the rate of epidural blood patch within a 15-day follow-up period. Headache duration, pain intensity, reduction of general activity, increase in length of hospital stay, adverse events, analgesic use (type and duration) and number of blood patches per patient in each group are recorded. Discussion We expect a decrease in the use of epidural blood patch in those receiving tetracosactide, thus indicating a decrease in PDPH symptoms in these patients. This will define the therapeutic success of tetracosactide and the possibility to use this treatment as a non-invasive alternative to blood patch for PDPH treatment. Trial registration Primary Registry ClinicalTrials.gov Protocol Registration and Results System Date of Registration 24 June 2016 Unique Protocol ID 69HCL15_0429 Secondary IDs EudraCT Number 2015–003357-17 ClinicalTrials.gov ID NCT02813655 ANSM 160214A-31 Protocol version V4 28/09/2018

scholarly journals Evaluation of the effectiveness and tolerance of tetracosactide in the treatment of post-dural puncture headaches (ESYBRECHE): A study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
Celia Depaulis ◽  
Nadia Steer ◽  
Léa Garessus ◽  
Dominique Chassard ◽  
Frederic Aubrun
Keyword(s):  
Hospital Stay ◽  
Dural Puncture ◽  
Epidural Blood Patch ◽  
Controlled Trial ◽  
Length Of Hospital Stay ◽  
Synthetic Analogue ◽  
General Activity ◽  
Activity Increase ◽  
Neuraxial Anaesthesia ◽  
Blood Patch

Abstract Background Post-dural puncture headache (PDPH) is one of the most common complications of neuraxial anaesthesia. It limits patients’ general activity and increases length of hospital stay and use of care. It is particularly disabling during the postpartum period, when mothers have to take care of their child. Epidural blood patch is the standard treatment for PDPH. However, it is an invasive procedure that may result in rare but serious complications. Recent evidence has suggested that adrenocorticotropic hormone (ACTH) is effective in the management of PDPH. The aim of this study is to assess the efficacy and safety of tetracosactide (Synacthen ® ), a synthetic analogue of ACTH, for PDPH treatment in patients who receive neuraxial anaesthesia during labour. Method This randomised, double-blind, placebo-controlled, parallel-arm trial, is performed in two French university hospitals. Eligible patients are those suffering from postpartum PDPH, who are randomised to receive either 1 mg of tetracosactide intravenously over 20 min, or 0.9% saline (placebo). The primary endpoint is the rate of epidural blood patch within a 15-day follow-up period. Headache duration, pain intensity, reduction of general activity, increase in length of hospital stay, adverse events, analgesic use (type and duration), and number of blood patches per patient in each group are recorded. Discussion We expect a decrease in the use of epidural blood patch in those receiving tetracosactide, thus indicating a decrease in PDPH symptoms in these patients. This will define the therapeutic success of tetracosactide and the possibility to use this treatment as a non-invasive alternative to blood patch for PDPH treatment.

scholarly journals Evaluation of the effectiveness and tolerance of tetracosactide in the treatment of post-dural puncture headaches (ESYBRECHE): A study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
Celia Depaulis ◽  
Nadia Steer ◽  
Dominique Chassard ◽  
Frederic Aubrun
Keyword(s):  
Length Of Stay ◽  
Dural Puncture ◽  
Epidural Blood Patch ◽  
Hospital Length ◽  
Neuraxial Anesthesia ◽  
Hospital Length Of Stay ◽  
Synthetic Analogue ◽  
General Activity ◽  
Activity Increase ◽  
Blood Patch

Abstract Background Post-dural puncture headache (PDPH) is one of the most common complications of neuraxial anesthesia. It limits patients’ general activity and increases hospital length of stay and use of care. It is particularly disabling during the postpartum period, when mothers have to take care of their child. Epidural blood patch is the standard treatment of PDPH. However, it is an invasive procedure that may result in rare but serious complications. Recent evidence suggests the effectiveness of adrenocorticotropic hormone (ACTH) in the management of PDPH. The aim of this study is to assess the efficacy and safety of tetracosactide (Synacthen®), a synthetic analogue of ACTH, in the treatment of PDPH in patients who received neuraxial anesthesia during labor. Method This is a randomized, double-blinded, placebo-controlled, parallel-arm trial, performed in two French university hospitals. Eligible patients are those suffering from postpartum PDPH, who are randomized to receive either 1 mg of tetracosactide intravenously over 20 min, or 0.9% saline (placebo). The primary endpoint of the study is the rate of epidural blood patch within a 15-day follow-up period. Duration of headache, intensity of pain, reduction of general activity, increase of hospital length of stay, adverse events, analgesic use (type and duration), and number of blood patches per patient in each group are recorded. Discussion We expect a decrease in the use of epidural blood patch in those who receive tetracosactide, thus indicating a decrease in PDPH symptoms in these patients. This will define the therapeutic success of tetracosactide and the possibility to use this treatment as a noninvasive alternative to blood patch in the treatment of PDPH.

scholarly journals Evaluation of the effectiveness and tolerance of tetracosactide in the treatment of post-dural puncture headaches (ESYBRECHE): A study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
Celia Depaulis ◽  
Nadia Steer ◽  
Dominique Chassard ◽  
Frederic Aubrun
Keyword(s):  
Length Of Stay ◽  
Dural Puncture ◽  
Epidural Blood Patch ◽  
Hospital Length ◽  
Neuraxial Anesthesia ◽  
Hospital Length Of Stay ◽  
Synthetic Analogue ◽  
General Activity ◽  
Activity Increase ◽  
Blood Patch

Abstract Background Post-dural puncture headache (PDPH) is one of the most common complications of neuraxial anesthesia. It limits patients’ general activity and increases hospital length of stay and use of care. It is particularly disabling during the postpartum period, when mothers have to take care of their child. Epidural blood patch is the standard treatment of PDPH. However, it is an invasive procedure that may result in rare but serious complications. Recent evidence suggests the effectiveness of adrenocorticotropic hormone (ACTH) in the management of PDPH. The aim of this study is to assess the efficacy and safety of tetracosactide (Synacthen®), a synthetic analogue of ACTH, in the treatment of PDPH in patients who received neuraxial anesthesia during labor. Method This is a randomized, double-blinded, placebo-controlled, parallel-arm trial, performed in two French university hospitals. Eligible patients are those suffering from postpartum PDPH, who are randomized to receive either 1 mg of tetracosactide intravenously over 20 min, or 0.9% saline (placebo). The primary endpoint of the study is the rate of epidural blood patch within a 15-day follow-up period. Duration of headache, intensity of pain, reduction of general activity, increase of hospital length of stay, adverse events, analgesic use (type and duration), and number of blood patches per patient in each group are recorded. Discussion We expect a decrease in the use of epidural blood patch in those who receive tetracosactide, thus indicating a decrease in PDPH symptoms in these patients. This will define the therapeutic success of tetracosactide and the possibility to use this treatment as a noninvasive alternative to blood patch in the treatment of PDPH.

Epidural Blood Patch as Treatment for Post Lumbar Puncture Headache — A Double Blind Controlled Trial

Cephalalgia ◽  
1989 ◽  
Vol 9 (10_suppl) ◽  
pp. 185-186
Author(s):  
Jeanne Seebacher ◽  
Valéria Ribeiro ◽  
Jean-Luc Le Guillou ◽  
Lucette Lacomblez ◽  
Michel Henry ◽  
...  
Keyword(s):  
Lumbar Puncture ◽  
Epidural Blood Patch ◽  
Controlled Trial ◽  
Double Blind ◽  
Blood Patch

Efficacy of a Prophylactic Epidural Blood Patch in Preventing Post Dural Puncture Headache in Parturients after Inadvertent Dural Puncture

2004 ◽  
Vol 101 (6) ◽  
pp. 1422-1427 ◽  
Author(s):  
Barbara M. Scavone ◽  
Cynthia A. Wong ◽  
John T. Sullivan ◽  
Edward Yaghmour ◽  
Saadia S. Sherwani ◽  
...  
Keyword(s):  
Dural Puncture ◽  
Epidural Blood Patch ◽  
Autologous Blood ◽  
Onset Time ◽  
Double Blind Study ◽  
Double Blind ◽  
Epidural Catheter Placement ◽  
Blood Patch ◽  
To Receive ◽  
Patch Group

Background Postdural puncture headache (PDPH) occurs in up to 80% of parturients who experience inadvertent dural puncture during epidural catheter placement. The authors performed a randomized double blind study to assess the effect of prophylactic epidural blood patch on the incidence of PDPH and the need for therapeutic epidural blood patch. Methods Sixty-four parturients who incurred inadvertent dural puncture were randomized to receive a prophylactic epidural blood patch with 20 ml autologous blood (prophylactic epidural blood patch group) or a sham patch (sham group). Subjects were evaluated daily for development of PDPH for a minimum of 5 days after dural puncture. Those who developed a PDPH were followed daily for a minimum of 3 days after resolution of the headache. Subjects with moderate headaches who reported difficulties performing childcare activities and all those with severe headaches were advised to receive a therapeutic epidural blood patch. Results Eighteen of 32 subjects in each group (56%) developed PDPH. Therapeutic blood patch was recommended in similar numbers of patients in each group. The groups had similar onset time of PDPH, median peak pain scores, and number of days spent unable to perform childcare activities as a result of postural headache. The median duration of PDPH, however, was shorter in the prophylactic epidural blood patch group. Conclusions A decrease in the incidence of PDPH or the need for criteria-directed therapeutic epidural patch was not detected when a prophylactic epidural blood patch was administered to parturients after inadvertent dural puncture. However, prophylactic epidural blood patch did shorten the duration of PDPH symptoms.

Epidural Blood Patch in the Treatment of Post Dural Puncture Headache: A Double Blind Study

1989 ◽  
Vol 29 (10) ◽  
pp. 630-632 ◽  
Author(s):  
J. Seebacher ◽  
V. Ribeiro ◽  
J. L. LeGuillou ◽  
L. Lacomblez ◽  
M. Henry ◽  
...  
Keyword(s):  
Dural Puncture ◽  
Epidural Blood Patch ◽  
Blind Study ◽  
Double Blind Study ◽  
Double Blind ◽  
Post Dural Puncture Headache ◽  
Blood Patch

scholarly journals Prophylactic Intrathecal Morphine and Prevention of Post–Dural Puncture Headache

2020 ◽  
Vol 132 (5) ◽  
pp. 1045-1052 ◽  
Author(s):  
Feyce M. Peralta ◽  
Cynthia A. Wong ◽  
Nicole Higgins ◽  
Paloma Toledo ◽  
Mary Jane Jones ◽  
...  
Keyword(s):  
Cranial Nerve ◽  
Dural Puncture ◽  
Epidural Blood Patch ◽  
Intrathecal Morphine ◽  
Saline Group ◽  
Morphine Group ◽  
Intrathecal Catheter ◽  
Double Blind ◽  
Post Dural Puncture Headache ◽  
Blood Patch

Abstract Background Prophylactic epidural morphine administration after unintentional dural puncture with a large-bore needle has been shown to decrease the incidence of post–dural puncture headache. The authors hypothesized that prophylactic administration of intrathecal morphine would decrease the incidence of post–dural puncture headache and/or need for epidural blood patch after unintentional dural puncture. Methods Parturients with an intrathecal catheter in situ after unintentional dural puncture with a 17-g Tuohy needle during intended epidural catheter placement for labor analgesia were enrolled in this randomized, double-blind trial. After delivery, subjects were randomized to receive intrathecal morphine 150 µg or normal saline. The primary outcome was the incidence of post–dural puncture headache. Secondary outcomes included onset, duration, and severity of post–dural puncture headache, the presence of cranial nerve symptoms and the type of treatment the patient received. Results Sixty-one women were included in the study. The incidence of post–dural puncture headache was 21 of 27 (78%) in the intrathecal morphine group and 27 of 34 (79%) in the intrathecal saline group (difference, −1%; 95% CI, −25% to 24%). There were no differences between groups in the onset, duration, or severity of headache, or presence of cranial nerve symptoms. Epidural blood patch was administered to 10 of 27 (37%) of subjects in the intrathecal morphine and 11 of 21 (52%) of the intrathecal saline group (difference 15%; 95% CI, −18% to 48%). Conclusions The present findings suggest that a single prophylactic intrathecal morphine dose of 150 µg administered shortly after delivery does not decrease the incidence or severity of post–dural puncture headache after unintentional dural puncture. This study does not support the clinical usefulness of prophylactic intrathecal morphine after an unintentional dural puncture. Editor’s Perspective What We Already Know about This Topic What This Article Tells Us That Is New

scholarly journals Comparisons of clinical characteristics, brain MRI findings, and responses to epidural blood patch between spontaneous intracranial hypotension and post-dural puncture headache: retrospective study

BMC Neurology ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Gha-Hyun Lee ◽  
Jiyoung Kim ◽  
Hyun-Woo Kim ◽  
Jae Wook Cho
Keyword(s):  
Intracranial Hypotension ◽  
Dural Puncture ◽  
Epidural Blood Patch ◽  
Brain Mri ◽  
Spontaneous Intracranial Hypotension ◽  
Vein Of Galen ◽  
Mri Findings ◽  
Post Dural Puncture Headache ◽  
Straight Sinus ◽  
Blood Patch

Abstract Background Spontaneous intracranial hypotension and post-dural puncture headache are both caused by a loss of cerebrospinal fluid but present with different pathogeneses. We compared these two conditions concerning their clinical characteristics, brain imaging findings, and responses to epidural blood patch treatment. Methods We retrospectively reviewed the records of patients with intracranial hypotension admitted to the Neurology ward of the Pusan National University Hospital between January 1, 2011, and December 31, 2019, and collected information regarding age, sex, disease duration, hospital course, headache intensity, time to the appearance of a headache after sitting, associated phenomena (nausea, vomiting, auditory symptoms, dizziness), number of epidural blood patch treatments, and prognosis. The brain MRI signs of intracranial hypotension were recorded, including three qualitative signs (diffuse pachymeningeal enhancement, venous distention of the lateral sinus, subdural fluid collection), and six quantitative signs (pituitary height, suprasellar cistern, prepontine cistern, mamillopontine distance, the midbrain-pons angle, and the angle between the vein of Galen and the straight sinus). Results A total of 105 patients (61 spontaneous intracranial hypotension patients and 44 post-dural puncture headache patients) who met the inclusion criteria were reviewed. More patients with spontaneous intracranial hypotension required epidural blood patch treatment than those with post-dural puncture headache (70.5% (43/61) vs. 45.5% (20/44); p = 0.01) and the spontaneous intracranial hypotension group included a higher proportion of patients who underwent epidural blood patch treatment more than once (37.7% (23/61) vs. 13.6% (6/44); p = 0.007). Brain MRI showed signs of intracranial hypotension in both groups, although the angle between the vein of Galen and the straight sinus was greater in the post-dural puncture headache group (median [95% Confidence Interval]: 85° [68°-79°] vs. 74° [76°-96°], p = 0.02). Conclusions Patients with spontaneous intracranial hypotension received more epidural blood patch treatments and more often needed multiple epidural blood patch treatments. Although both groups showed similar brain MRI findings, the angle between the vein of Galen and the straight sinus differed significantly between the groups.

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