Long Term Outcomes After Accidental Dural Puncture ADP Study
CompletedNCT03080779
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- 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
- Conditions
- Post-Dural Puncture Headache
- Chronic Headache
- Chronic Low Back Pain
- Sponsor
- University Hospitals, Leicester
- Start date
- 2017-02-03
- Primary completion
- 2020-04-27
- Sex
- Female
- Age range
- from 18 Years to 50 Years
- Results posted
- No results posted in this snapshot
- Countries
- United Kingdom
- Total sites listed
- 3
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03080779