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Long Term Outcomes After Accidental Dural Puncture ADP Study

NCT03080779 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 270

Last updated 2020-08-13

No results posted yet for this study

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). 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.

Conditions

  • Post-Dural Puncture Headache
  • Chronic Headache
  • Chronic Low Back Pain

Sponsors & Collaborators

  • University Hospitals, Leicester

    lead OTHER

Principal Investigators

  • N Gopinath · University Hospitals, Leicester

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-03
Primary Completion
2020-04-27
Completion
2020-06-27

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03080779 on ClinicalTrials.gov