Long Term Outcomes After Accidental Dural Puncture ADP Study

NCT03080779 | Completed

• 1 other identifier: UHLeicester
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

• The incidence of chronic headache at 18 months in the ADP group when compared to the control non-ADP group

  Questionnaire

  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.

  18 months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Obstetric

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospitals, Leicester: lead

Study Sites (3)

University Hospitals of Leicester NHS Trust

Leicester, Leicestershire, LE54PW, United Kingdom

Location

Bedford Hospitals NHS Trust

Bedford, United Kingdom

Location

Royal Derby Hospitals

Derby, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 33891312 DERIVED

MeSH Terms

Conditions

Post-Dural Puncture Headache; Headache Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• N Gopinath

  University Hospitals, Leicester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: March 15, 2017
• Study Start: February 3, 2017
• Primary Completion: April 27, 2020
• Study Completion: June 27, 2020
• Last Updated: August 13, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)