Parturient Who Develop a Postdural Puncture Headache Clinical Trial
Official title:
Chronic Headache and Chronic Backache Following Unintentional Dural Puncture at Delivery Room
he study is a telephone questionnaire. The study will include 400 women, 100 in each group.
OBJECTIVE: To investigate the prevalence of chronic and chronic back pain following PDPH
accidental dural puncture during epidyral analgesia for delivery.
1. Parturients who gave birth to a normal birth and did not receive epidural anesthesia.
2. Parturients who gave birth to a normal birth with epidural anesthesia without an
unintentional dural puncture.
3. Parturients who gave birth to a normal birth with epidural anesthesia and had an
unintentional dural puncture, these women were treated conservatively.
4. Parturients who had a normal birth with epidural anesthesia and had an unintentional
dural puncture and were treated with a blood patch following PDPH.
Epidural anesthesia for pain relief during childbirth is performed in about 70% of the
parturients in Shaare Zedek Medical Center. The most common complication of epidural
analgesia is an unintentional dural puncture occurring in 0.4% -6% of births. Puncture causes
acute headache in 70% -80% of cases. The standard treatment is the first stage of
conservative treatment of painkillers and caffeine and in the absence of improvement of
perform epidural blood patch 24-48 hours after the dural puncture was performed.
There is no widespread support for the literature that a dural puncture with a large diameter
needle is a risk factor for the development of chronic headache. For this purpose, we are
interested in conducting a study to examine the prevalence of chronic headache and back pain
in parturients who underwent epidural anesthesia with a dural puncture to confront
parturients who underwent epidural anesthesia without puncturing the dura membrane.
We know that in the years 2017-208 there were about 100 women in the hospital who had a blood
patch and a similar number of women who had PDPH and were treated conservatively. From the
medical records, we will randomize another 200 mothers, of which 100 were born naturally
without epidural anesthesia and another 100 who gave birth to a normal birth with epidural
anesthesia without dural puncture.
The study will be conducted using a telephone questionnaire. The telephone questionnaire will
be taken at least six months after the epidural anesthesia check if the symptoms are chronic
in nature.
Telephone questionnaire carried out four groups of mothers:
1. Parturients who gave birth to a normal birth and did not receive epidural anesthesia.
2. Parturients who gave birth to a normal birth with epidural anesthesia without an
unintentional dural puncture.
3. Parturients who gave birth to a normal birth with epidural anesthesia and had an
unintentional dural puncture, these women were treated conservatively.
4. Parturients who had a normal birth with epidural anesthesia and had an unintentional
dural puncture and were treated with a blood patch following PDPH.
The questionnaire will be performed after receiving informed consent from the patient. Each
group will have 100 women.
The questionnaire (attached as an appendix) will examine the prevalence of chronic headache
and chronic back pain in these women. Our hypothesis is that in women with PDPH the incidence
of chronic headache will be higher.
The statistical comparison between the groups will examine demographic characteristics and
characteristics related to frequency of pain, intensity, restriction of daily activity and
ways to relieve pain.
Comparisons between the groups for continuous variables will be done with the student t-test
and data are presented as mean (standard deviation (SD)), for nonparametric tests with
Mann-Whitney test and data are presented as median (interquartile range) ) [range] and for
categorical values with Chi-square test and data are presented as number (percentage). A
p-values <0.01 will be considered significant due to multiple comparisons. A multivariable
regression analysis will be performed to evaluate factors (PDPH, epidural blood patch (EBP),
chronic headache, chronic backache) associated with PPD.
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