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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A01921-46 | Other Identifier | RCB number |
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no inclusion
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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.
The secondary objectives of this study are to:
A. To evaluate the number of blood patches needed for each patient during her hospital stay B. Assessing the intensity of all headaches every 24H C. Evaluate the complications occurring during the hospital stay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The study population | Experimental | The study population consists of adult women requiring an epidural blood patch for the treatment of post-dural puncture headache following vaginal delivery. Women who delivered by cesarean section are not included due to the discomfort of the prone position while there is an abdominal scar. Intervention: Prone position for 1 hour after blood patch |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prone position for 1 hour after blood patch | Other | After performing a blood patch, the patient will be placed in a prone position for 1 hour. This applies to all blood patches required during her hospitalization. |
| Measure | Description | Time Frame |
|---|---|---|
| Headache recurrence: yes/no | Headache recurrence defined by: presence of headaches that confine the mother to bed or affect her ability to take care of her baby | 24 hours after first blood patch |
| Headache recurrence: yes/no | Headache recurrence defined by: presence of headaches that confine the mother to bed or affect her ability to take care of her baby | 48 hours after first blood patch |
| Headache recurrence: yes/no | Headache recurrence defined by: presence of headaches that confine the mother to bed or affect her ability to take care of her baby | 72 hours after first blood patch |
| Measure | Description | Time Frame |
|---|---|---|
| The number of blood patches required for each patient | Hospital discharge (expected average of 7 days) | |
| Visual analog scale for pain | Scale from 0.0 to 10.0. | Baseline (day 0) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guy Aya, MD | Centre Hospitalier Universitaire de NÄ«mes | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
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| Blood patch | Procedure | And indicated in inclusion criteria, patients in this protocol will have at least 1 blood patch. The amount of blood to be injected into the peridural space is fixed at 20 ml, but can be less in case of pain. |
|
| Visual analog scale for pain | Scale from 0.0 to 10.0. | 24 hours after blood patch |
| Visual analog scale for pain | Scale from 0.0 to 10.0. | 48 hours after blood patch |
| Visual analog scale for pain | Scale from 0.0 to 10.0. | 72 hours after blood patch |
| Presence/absence of complications | Presence / absence of the following complications: nerve paresthesia; nerve damage; accidental dural puncture; subcutaneous hematoma at the puncture site; meningitis; epidural abscess; localized infection at the puncture site; encephalopathy; cerebral venous thrombosis; subdural hematoma | During hospital stay (expected average of 7 days) |
| In case of recurrence of headache following the 1st blood patch, the presence / absence of the following accompanying symptoms: nausea; vomiting; dizziness; tinnitus; diplopia; photophobia; low back pain. | During hospital stay (expected average of 7 days) |
| ID | Term |
|---|---|
| D051299 | Post-Dural Puncture Headache |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D016684 | Prone Position |
| D017217 | Blood Patch, Epidural |
| ID | Term |
|---|---|
| D011187 | Posture |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007268 | Injections, Epidural |
| D007278 | Injections, Spinal |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
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