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Long Term Outcomes After Accidental Dural Puncture ADP Study

This study is currently recruiting participants.
Verified September 2017 by University Hospitals, Leicester
Sponsor:
ClinicalTrials.gov Identifier:
NCT03080779
First Posted: March 15, 2017
Last Update Posted: October 3, 2017
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.
Information provided by (Responsible Party):
University Hospitals, Leicester
  Purpose
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.

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by University Hospitals, Leicester:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]
    Questionnaire


Estimated Enrollment: 270
Actual Study Start Date: February 3, 2017
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Obstetric
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03080779


Contacts
Contact: Niraj Gopinath, FFPMRCA 01162584661 niraj.gopinath@uhl-tr.nhs.uk

Locations
United Kingdom
University Hospitals of Leicester NHS Trust Recruiting
Leicester, Leicestershire, United Kingdom, LE54PW
Contact: Niraj Gopinath, FFPMRCA         
Bedford Hospitals NHS Trust Recruiting
Bedford, United Kingdom
Contact: Pallab Rudra, FRCA         
Royal Derby Hospitals Recruiting
Derby, United Kingdom
Contact: Alison Brewer, FRCA         
Sponsors and Collaborators
University Hospitals, Leicester
Investigators
Principal Investigator: N Gopinath University Hospitals, Leicester
  More Information

Responsible Party: University Hospitals, Leicester
ClinicalTrials.gov Identifier: NCT03080779     History of Changes
Other Study ID Numbers: UHLeicester
First Submitted: December 20, 2016
First Posted: March 15, 2017
Last Update Posted: October 3, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Headache
Headache Disorders
Post-Dural Puncture Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Headache Disorders, Secondary