Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Chronic Headache and Chronic Backache Following Unintentional Dural Puncture at Delivery Room.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03908424
Recruitment Status : Not yet recruiting
First Posted : April 9, 2019
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Alexander Ioscovich, Shaare Zedek Medical Center

Tracking Information
First Submitted Date April 4, 2019
First Posted Date April 9, 2019
Last Update Posted Date April 9, 2019
Estimated Study Start Date May 1, 2019
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 7, 2019)
  • Chronic Headache [ Time Frame: At least six months after birth. ]
    Chronic headache development after PDPH, comparison between different groups. The diagnosis of chronic headache will be done using a questionnaire (attached as an appendix) including the Chronic Pain Grade Questionnaire (Smith et al). The main questions in the questionnaire are the incidence of headache, the severity of the headache, the duration of the problem. Disability Index is also determined by the questions about limiting pain in daily activities.
  • chronic Backache [ Time Frame: At least six months after birth. ]
    Chronic backache development after PDPH, comparison between different groups. The diagnosis of chronic back pain will be done using a questionnaire (attached as an appendix) including the Low Back Pain Rating Scale (Manniche et al.). The main questions in the questionnaire are the incidence of back pain, severity of back pain, duration of the problem. Disability Index is also determined by the questions about limiting pain in daily activities.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Chronic Headache and Chronic Backache Following Unintentional Dural Puncture at Delivery Room.
Official Title Chronic Headache and Chronic Backache Following Unintentional Dural Puncture at Delivery Room
Brief Summary

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.
Detailed Description

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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Women who gave birth at Shaare Zedek Medical Center are a tertiary hospital with more than 16,000 births a year. Fifty-five percent of women give birth with epidural anesthesia.
Condition
  • Parturient Who Underwent Epidural Anesthesia During Which an Unintentional Dural Punctur Occurred
  • Parturient Who Develop a Postdural Puncture Headache
  • Parturient Who Gave Informed Consent to Participation in the Study
Intervention Other: Epidural Blood patch.
An epidural blood patch is a surgical procedure that uses autologous blood in order to close one or many holes in the dura mater of the spinal cord, usually as a result of a previous lumbar puncture. A small amount of the patient's blood is injected into the epidural space near the site of the original puncture; the resulting blood clot then "patches" the meningeal leak. An epidural needle is inserted into the epidural space at the site of the cerebrospinal fluid leak and blood is injected. The clotting factors of the blood close the hole in the dura.
Study Groups/Cohorts
  • CONTROL
    Parturients who gave birth to a normal birth and did not receive epidural anesthesia.
  • Normal Epidural
    Parturients who gave birth to a normal birth with epidural anesthesia without an unintentional dural puncture.
  • PDPH conservative treatment
    Parturients who gave birth to a normal birth with epidural anesthesia and had an unintentional dural puncture, these women were treated conservatively.
  • PDPH treated with Blood Patch
    . Parturients who had a normal birth with epidural anesthesia and had an unintentional dural puncture and were treated with a blood patch following PDPH.
    Intervention: Other: Epidural Blood patch.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: April 7, 2019)
400
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Parturient who underwent epidural anesthesia during which an unintentional dural punctur occurred.
  • Parturient who develop a postdural puncture headache.
  • Parturient who gave informed consent to participation in the study.

Exclusion Criteria:

  • Parturient without a clear dural hole during operation.
  • Parturient who have chronic headaches or migraines.
  • Parturient who have chronic back pain.
  • Parturient who did not give informed consent.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Alex Ioscovich, Prof 972508685052 aioscovich@gmail.com
Contact: Yair Binyamin, Dr 972586963871 yairben1@gmail.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03908424
Other Study ID Numbers 0335-18-SZMC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Alexander Ioscovich, Shaare Zedek Medical Center
Study Sponsor Shaare Zedek Medical Center
Collaborators Not Provided
Investigators Not Provided
PRS Account Shaare Zedek Medical Center
Verification Date April 2019