Post-Dural Puncture HeadacheNCT03080779
Long Term Outcomes After Accidental Dural Puncture ADP Study
An observational study of Post-Dural Puncture Headache and Chronic Headache, run by University Hospitals, Leicester at 3 sites in United Kingdom.
Trial summary
Post Dural Puncture Headache (PDPH) causes significant short-term disability, prevents mobilisation, affects childcare activities and results in prolonged hospital stay. Initial treatment involves painkillers and if patient fails to respond, an Epidural Blood Patch (EBP). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Post-Dural Puncture Headache, Chronic Headache, Chronic Low Back Pain
- How many people
- 270 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 3 Feb 2017to 27 Jun 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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Obstetric
Who may be able to join
- Index: Participants aged over 18 years who have sustained accidental dural puncture with 16-gauge Tuohy needle
- Control: Participants aged over 18 years who have received uneventful epidural insertion with 16-gauge Tuohy needle
Who cannot join
- Lack of consent including from those participants who lack mental capacity to give informed consent
- Pre-existing chronic headache (the patients suffer from 15 or more headache days every month)
- Pre-existing chronic low back pain (the patients suffer from 7 or more low back pain days every month)
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Bedford Hospitals NHS Trust
Bedford
Royal Derby Hospitals
Derby
University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, LE54PW
About this study
Official title: The Incidence of Chronic Headache and Low Back Pain After Accidental Dural Puncture (ADP) With a Tuohy Needle and Epidural Blood Patch in the Obstetric Population: A Prospective 2-group Cohort Multicentre Study
Post Dural Puncture Headache (PDPH) causes significant short-term disability, prevents mobilisation, affects childcare activities and results in prolonged hospital stay. Initial treatment involves painkillers and if patient fails to respond, an Epidural Blood Patch (EBP). EBP involves taking patient's blood and injecting into the epidural space. It is generally agreed that PDPH is a self-limiting condition and resolves in two weeks. However there is emerging evidence that patients with PDPH could be at an increased risk of developing longstanding (chronic) headaches. Retrospective case studies show that between 28 - 34% of patients who developed PDPH had longstanding headaches at 18 months after the insertion of the epidural. There is also recent evidence of new onset low back pain developing in patients who have received an epidural blood patch that was performed to treat PDPH. Nearly two thirds of patients from a hospital in UK had new onset low back pain after they had received epidural blood patch treatment. Presently, there is no prospective clinical study evaluating the development of longstanding headaches and new onset low back pain after the development of PDPH. Aim of the present study is to evaluate the incidence of longstanding headache after accidental dural (ADP) puncture and the incidence of new onset low back pain after epidural blood patch treatment.
Read the detailed description
Headache can be a complication after insertion of an epidural needle for pain relief during labour. The headache is called Post Dural Puncture Headache (PDPH). PDPH causes significant short-term disability, prevents mobilisation, affects childcare activities and results in prolonged hospital stay. Initial treatment involves painkillers and if patient fails to respond, an Epidural Blood Patch (EBP). EBP involves taking patient's blood and injecting into the epidural space. It is generally agreed that PDPH is a self-limiting condition and resolves in two weeks. However there is emerging evidence that patients with PDPH could be at an increased risk of developing longstanding (chronic) headaches. Retrospective case studies show that between 28 - 34% of patients who developed PDPH had longstanding headaches at 18 months after the insertion of the epidural. There is also recent evidence of new onset low back pain developing in patients who have received an epidural blood patch that was performed to treat PDPH. Nearly two thirds of patients from a hospital in UK had new onset low back pain after they had received epidural blood patch treatment. Presently, there is no prospective clinical study evaluating the development of longstanding headaches and new onset low back pain after the development of PDPH.
Aim of the present study is to evaluate the incidence of longstanding headache after accidental dural (ADP) puncture and the incidence of new onset low back pain after epidural blood patch treatment.
Methods: The proposed study is a prospective, cohort study that will be conducted at six centres (Leicester, Derby, Bradford, Colchester, Bedford and Cambridge) over 36 months. Index participants who suffer ADP will be matched with control participants who have received an uneventful epidural insertion. The index and control participants will be matched for age, body weight, parity and the type of delivery. Mothers who have longstanding headache or low back pain will be excluded form the study. After providing written consent, the participants will be provided with a questionnaire pack containing three sets of two questionnaires to be completed at 6, 12 and 18 months after developing the headache as well as stamped envelopes to return the questionnaires to the research team. A research team member will perform telephone follow up 6, 12 and 18 months to encourage completion of the questionnaires. Participation in the study will end at 18 months after completion of the study questionnaires.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| ADP Group | Index group includes participants who have suffered an accidental dural puncture with a 16 gauge Tuohy needle | |
| Non-ADP group | Control group includes participants who received an uneventful epidural analgesia with a 16 gauge Tuohy needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of chronic headache at 18 months in the ADP group when compared to the control non-ADP group
Questionnaire
Measured: 18 months
Secondary outcomes (1)
The incidence of chronic low back pain at 18 months in the ADP group when compared to the control non-ADP group.
Questionnaire
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start3 Feb 2017
- Primary completion27 Apr 2020
- Study completion27 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Dural Puncture HeadacheStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- N Gopinath, Principal investigator, University Hospitals, Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080779
- Sponsor's protocol ID
- UHLeicester
- Status last verified
- Aug 2020
- First submitted
- 20 Dec 2016
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Niraj G, Mushambi M, Gauthama P, Patil A, Kelkar A, Hart E, Nurmikko T; Accidental Dural Puncture Outcome Study Collaborative Group. Persistent headache and low back pain after accidental dural puncture in the obstetric population: a prospective, observational, multicentre cohort study. Anaesthesia. 2021 Aug;76(8):1068-1076. doi: 10.1111/anae.15491. Epub 2021 Apr 23.
PubMed 33891312
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Chronic Headache and Low Back Pain After Accidental Dural Puncture (ADP) With a Tuohy Needle and Epidural Blood Patch in the Obstetric Population: A Prospective 2-group Cohort Multicentre Study
- ClinicalTrials.gov ID
- NCT03080779
- Acronym / sponsor ID
- UHLeicester
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Study start
- 3 Feb 2017 (actual)
- Primary completion
- 27 Apr 2020 (actual)
- Study completion
- 27 Jun 2020 (actual)
- First posted
- 15 Mar 2017 (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.
Post Dural Puncture Headache (PDPH) causes significant short-term disability, prevents mobilisation, affects childcare activities and results in prolonged hospital stay. Initial treatment involves painkillers and if patient fails to respond, an Epidural Blood Patch (EBP). EBP involves taking patient's blood and injecting into the epidural space. It is generally agreed that PDPH is a self-limiting condition and resolves in two weeks. However there is emerging evidence that patients with PDPH could be at an increased risk of developing longstanding (chronic) headaches. Retrospective case studies show that between 28 - 34% of patients who developed PDPH had longstanding headaches at 18 months after the insertion of the epidural. There is also recent evidence of new onset low back pain developing in patients who have received an epidural blood patch that was performed to treat PDPH. Nearly two thirds of patients from a hospital in UK had new onset low back pain after they had received epidural blood patch treatment. Presently, there is no prospective clinical study evaluating the development of longstanding headaches and new onset low back pain after the development of PDPH. Aim of the present study is to evaluate the incidence of longstanding headache after accidental dural (ADP) puncture and the incidence of new onset low back pain after epidural blood patch treatment.
Detailed description
Headache can be a complication after insertion of an epidural needle for pain relief during labour. The headache is called Post Dural Puncture Headache (PDPH). PDPH causes significant short-term disability, prevents mobilisation, affects childcare activities and results in prolonged hospital stay. Initial treatment involves painkillers and if patient fails to respond, an Epidural Blood Patch (EBP). EBP involves taking patient's blood and injecting into the epidural space. It is generally agreed that PDPH is a self-limiting condition and resolves in two weeks. However there is emerging evidence that patients with PDPH could be at an increased risk of developing longstanding (chronic) headaches. Retrospective case studies show that between 28 - 34% of patients who developed PDPH had longstanding headaches at 18 months after the insertion of the epidural. There is also recent evidence of new onset low back pain developing in patients who have received an epidural blood patch that was performed to treat PDPH. Nearly two thirds of patients from a hospital in UK had new onset low back pain after they had received epidural blood patch treatment. Presently, there is no prospective clinical study evaluating the development of longstanding headaches and new onset low back pain after the development of PDPH.
Aim of the present study is to evaluate the incidence of longstanding headache after accidental dural (ADP) puncture and the incidence of new onset low back pain after epidural blood patch treatment.
Methods: The proposed study is a prospective, cohort study that will be conducted at six centres (Leicester, Derby, Bradford, Colchester, Bedford and Cambridge) over 36 months. Index participants who suffer ADP will be matched with control participants who have received an uneventful epidural insertion. The index and control participants will be matched for age, body weight, parity and the type of delivery. Mothers who have longstanding headache or low back pain will be excluded form the study. After providing written consent, the participants will be provided with a questionnaire pack containing three sets of two questionnaires to be completed at 6, 12 and 18 months after developing the headache as well as stamped envelopes to return the questionnaires to the research team. A research team member will perform telephone follow up 6, 12 and 18 months to encourage completion of the questionnaires. Participation in the study will end at 18 months after completion of the study questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADP Group | – | –Index group includes participants who have suffered an accidental dural puncture with a 16 gauge Tuohy needle |
| Non-ADP group | – | –Control group includes participants who received an uneventful epidural analgesia with a 16 gauge Tuohy needle |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Obstetric
Key inclusion criteria (2 listed)
- Index: Participants aged over 18 years who have sustained accidental dural puncture with 16-gauge Tuohy needle
- Control: Participants aged over 18 years who have received uneventful epidural insertion with 16-gauge Tuohy needle
Key exclusion criteria (3 listed)
- Lack of consent including from those participants who lack mental capacity to give informed consent
- Pre-existing chronic headache (the patients suffer from 15 or more headache days every month)
- Pre-existing chronic low back pain (the patients suffer from 7 or more low back pain days every month)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The incidence of chronic headache at 18 months in the ADP group when compared to the control non-ADP group
Time frame: 18 months
Questionnaire
1 secondary outcome
The incidence of chronic low back pain at 18 months in the ADP group when compared to the control non-ADP group.
Time frame: 18 months
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 13 Aug 2020.
- Derived from this study: PubMed 33891312Niraj G, Mushambi M, Gauthama P, Patil A, Kelkar A, Hart E, Nurmikko T; Accidental Dural Puncture Outcome Study Collaborative Group. Persistent headache and low back pain after accidental dural puncture in the obstetric population: a prospective, observational, multicentre cohort study. Anaesthesia. 2021 Aug;76(8):1068-1076. doi: 10.1111/anae.15491. Epub 2021 Apr 23.
- Individual participant dataSharing planned: No
Related trials for Post-Dural Puncture Headache
Not yet recruiting
Comparing Spinal, Epidural, and Dural Puncture Epidural Anesthesia for Cesarean Delivery: Hemodynamics and Block Quality
Hypotension After Neuraxial Anesthesia, Cesarean Section
Not yet recruitingPhase 4
Effect of Intravenous Oxytocin on Post Dural Puncture Headache After Caesarean Sections
Post Dural Puncture Headache
RecruitingObservational study
Effect of Altitude on Postdural Puncture Headache After Caesarean Delivery
Post-Dural Puncture Headache
Enrolling by invitation
Ultrasound-assisted vs Palpation-guided Lumbar Punctures
Lumbar Puncture
RecruitingEarly Phase 1
Comparison of Nebulized Neostigmine/Atropine Versus Lignocaine in Treating Acute Post-dural Puncture Headache Following Subarachnoid Block in Parturient Undergoing Elective Cesarean Section. A Randomized, Clinical Trial.
Post-Dural Puncture Headache
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.
N Gopinath principal investigator
University Hospitals, Leicester
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Dural Puncture Headache and Chronic Headache, run by University Hospitals, Leicester at 3 sites in United Kingdom.
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 2 inclusion and 3 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 13 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 3 sites in United Kingdom. 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?
The incidence of chronic headache at 18 months in the ADP group when compared to the control non-ADP group (time frame: 18 months). 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 NCT03080779, which also lists 1 linked publication.
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 13 Aug 2020.