Parturient Who Underwent Epidural Anesthesia During Which an Unintentional Dural Punctur OccurredNCT03908424
Chronic Headache and Chronic Backache Following Unintentional Dural Puncture at Delivery Room.
An observational study of Parturient Who Underwent Epidural Anesthesia During Which an Unintentional Dural Punctur Occurred and Parturient Who Develop a Postdural Puncture Headache, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- 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
- What is being tested?
- Epidural Blood patch.
- How many people
- 389 participants
- Where
- 1 siteIsrael
- Study dates
- 1 May 2019to 11 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Parturients who gave birth to a normal birth and did not receive epidural anesthesia.
- Parturients who gave birth to a normal birth with epidural anesthesia without an unintentional dural puncture.
- Parturients who gave birth to a normal birth with epidural anesthesia and had an unintentional dural puncture, these women were treated conservatively.
- Parturients who had a normal birth with epidural anesthesia and had an unintentional dural puncture and were treated with a blood patch following PDPH.
Read the 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:
- Parturients who gave birth to a normal birth and did not receive epidural anesthesia.
- Parturients who gave birth to a normal birth with epidural anesthesia without an unintentional dural puncture.
- Parturients who gave birth to a normal birth with epidural anesthesia and had an unintentional dural puncture, these women were treated conservatively.
- 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.
- Conditions
- 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
- Being tested
- Epidural Blood patch.
- Keywords
- PDPH - Post Dural Puncture Headache, chronic headache, chronic backache
- Medical subject headings
- Post-Dural Puncture Headache, Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural Blood patch.Other
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Epidural Blood patch. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic Headache
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.
Measured: At least six months after birth.
chronic Backache
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.
Measured: At least six months after birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start1 May 2019
- Primary completion11 Aug 2020
- Study completion11 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Parturient Who Underwent Epidural Anesthesia During Which an Unintentional Dural Punctur OccurredStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 389 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Ioscovich, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908424
- Sponsor's protocol ID
- 0335-18-SZMC
- Status last verified
- Aug 2020
- First submitted
- 4 Apr 2019
- Last updated
- 14 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Loubert C, Hinova A, Fernando R. Update on modern neuraxial analgesia in labour: a review of the literature of the last 5 years. Anaesthesia. 2011 Mar;66(3):191-212. doi: 10.1111/j.1365-2044.2010.06616.x.
PubMed 21320088Paech M, Banks S, Gurrin L. An audit of accidental dural puncture during epidural insertion of a Tuohy needle in obstetric patients. Int J Obstet Anesth. 2001 Jul;10(3):162-7. doi: 10.1054/ijoa.2000.0825.
PubMed 15321604Berger CW, Crosby ET, Grodecki W. North American survey of the management of dural puncture occurring during labour epidural analgesia. Can J Anaesth. 1998 Feb;45(2):110-4. doi: 10.1007/BF03013247.
PubMed 9512843MacArthur C, Lewis M, Knox EG. Accidental dural puncture in obstetric patients and long term symptoms. BMJ. 1993 Apr 3;306(6882):883-5. doi: 10.1136/bmj.306.6882.883.
PubMed 8490410Smith BH, Penny KI, Purves AM, Munro C, Wilson B, Grimshaw J, Chambers WA, Smith WC. The Chronic Pain Grade questionnaire: validation and reliability in postal research. Pain. 1997 Jun;71(2):141-7. doi: 10.1016/s0304-3959(97)03347-2.
PubMed 9211475
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Headache and Chronic Backache Following Unintentional Dural Puncture at Delivery Room
- ClinicalTrials.gov ID
- NCT03908424
- Acronym / sponsor ID
- 0335-18-SZMC
- Conditions
- 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
- Keywords
- PDPH - Post Dural Puncture Headache, chronic headache, chronic backache
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 389 participants (actual)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 11 Aug 2020 (actual)
- Study completion
- 11 Aug 2020 (actual)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Parturients who gave birth to a normal birth and did not receive epidural anesthesia.
- Parturients who gave birth to a normal birth with epidural anesthesia without an unintentional dural puncture.
- Parturients who gave birth to a normal birth with epidural anesthesia and had an unintentional dural puncture, these women were treated conservatively.
- 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:
- Parturients who gave birth to a normal birth and did not receive epidural anesthesia.
- Parturients who gave birth to a normal birth with epidural anesthesia without an unintentional dural puncture.
- Parturients who gave birth to a normal birth with epidural anesthesia and had an unintentional dural puncture, these women were treated conservatively.
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: Epidural 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | PDPH treated with Blood Patch |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
- Results publication: PubMed 21320088Loubert C, Hinova A, Fernando R. Update on modern neuraxial analgesia in labour: a review of the literature of the last 5 years. Anaesthesia. 2011 Mar;66(3):191-212. doi: 10.1111/j.1365-2044.2010.06616.x.
- Results publication: PubMed 15321604Paech M, Banks S, Gurrin L. An audit of accidental dural puncture during epidural insertion of a Tuohy needle in obstetric patients. Int J Obstet Anesth. 2001 Jul;10(3):162-7. doi: 10.1054/ijoa.2000.0825.
- Results publication: PubMed 9512843Berger CW, Crosby ET, Grodecki W. North American survey of the management of dural puncture occurring during labour epidural analgesia. Can J Anaesth. 1998 Feb;45(2):110-4. doi: 10.1007/BF03013247.
- Results publication: PubMed 8490410MacArthur C, Lewis M, Knox EG. Accidental dural puncture in obstetric patients and long term symptoms. BMJ. 1993 Apr 3;306(6882):883-5. doi: 10.1136/bmj.306.6882.883.
- Results publication: PubMed 9211475Smith BH, Penny KI, Purves AM, Munro C, Wilson B, Grimshaw J, Chambers WA, Smith WC. The Chronic Pain Grade questionnaire: validation and reliability in postal research. Pain. 1997 Jun;71(2):141-7. doi: 10.1016/s0304-3959(97)03347-2.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parturient Who Underwent Epidural Anesthesia During Which an Unintentional Dural Punctur Occurred and Parturient Who Develop a Postdural Puncture Headache, run by Shaare Zedek Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic Headache (time frame: At least six months after birth.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03908424, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2020.