Long term outcome after accidental dural puncture in obstetric populat
Research type
Research Study
Full title
The incidence of chronic headache and low back pain after accidental dural puncture with a Tuohy needle and epidural blood patch in the obstetric population: a prospective 2-group cohort study
IRAS ID
211698
Contact name
Niraj Gopinath
Contact email
Sponsor organisation
University Hospitals of Leicester NHS Trust
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Background: Headache can be a complication after insertion of an epidural needle for pain relief during labour when an accidental hole (accidental dural puncture ADP) is created in the sheath (dura) that covers the spinal cord. The headache is called Postdural Puncture Headache (PDPH). PDPH causes significant short-term disability and results in prolonged hospital stay. Standard treatment involves taking patient’s blood and injecting into the epidural space (Epidural blood patch EBP). PDPH is a self-limiting condition and resolves in two weeks. There is emerging evidence that patients who suffer ADP are at an increased risk of developing longstanding headaches. A retrospective case study showed that 28% of patients who developed PDPH had longstanding headaches at 18 months after ADP.
Two thirds of patients from a hospital in UK had new onset low back pain after they had received EBP treatment. Presently, there is no prospective clinical study evaluating the development of longstanding headaches and new onset low back pain following ADP and its management.Aim is to evaluate the incidence of longstanding headache after ADP and the incidence of new onset low back pain after EBP.
Methods: The prospective, cohort study that will be conducted at three centres (Leicester, Derby, and Sheffield) over 36 months.
Index participants who suffer ADP will be matched with control participants who have received an uneventful epidural insertion.
Matching criteria: age, body weight, parity and type of delivery.
Mothers who have longstanding headache or low back pain will be excluded.
After providing written consent, participants will complete three questionnaire.
Thereafter, 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 ADP as well as stamped envelopes to return questionnaires to research team.Participation will end at 18 months after completion of study questionnaires.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
16/EM/0457
Date of REC Opinion
22 Nov 2016
REC opinion
Further Information Favourable Opinion