Pregabalin for dural puncture headache

Pregabalin for the management of post-dural puncture headache after unintentional dural puncture in obstetric patients: a randomised, double-blind, placebo-controlled trial

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616000016437

Enrollment

Registered

2016-01-13

Start date

2016-07-09

Completion date

2016-07-22

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study is to investigate the efficacy of pregabalin against headache resulting from unintentional dural puncture in obstetric patients having epidural analgesia for labour and delivery. The primary question addressed is “Does pregabalin reduce the severity of post-dural puncture headache in postpartum women after unintentional dural puncture?” Our hypothesis is that oral pregabalin will significantly reduce the severity of post-dural puncture headache in postpartum women experiencing the complication of unintentional dural puncture. The question is addressed by conduct of a randomized, double-blind, placebo-controlled, parallel-group, superiority clinical trial. The study drugs will be commenced after unintentional dural puncture and patients followed for one week, with the incidence and severity of headache important outcomes showing whether pregablin is effective compared with a placebo.

Interventions

Arm 1: Prophylactic administration of oral pregabalin capsule twice daily. Dose 75 mg/75 mg for 2 days then 75 mg/150 mg for 2 days Arm 2: Prophylactic administration of oral plabebo capsules twice daily Total number of study drug capsules consumed will be recorded

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Obstetric women aged 18 years and over 2. An unintentional dural puncture at the time of epidural analgesia for labour and delivery, confirmed by observation of efflux of cerebrospinal fluid from the needle or catheter; by identification of CSF from an epidural catheter; or by positive test-dosing for subarachnoid placement.

Exclusion criteria

1. Attempted postpartum prevention of PDPH using any therapy other than intrathecal epidural catheter placement, including prophylactic epidural blood patch. 2. Onset of PDPH prior to study drug administration 3. Renal impairment 4. Contraindication to use or exposure to pregabalin within past 72 hours 5. ASA 4 status 6. Women planning to breastfeed a premature baby 7. Concurrent administration of drugs that may possibly impact on the severity of PDPH, namely oral tablets of or intravenous caffeine, triptans, hydrocortisone, oral theophylline or intravenous aminophylline, epidural morphine.

Outcome results