Incidence of Headache Following an Unintentional Dural Puncture
Condition: Postdural Puncture Headache; Post-Lumbar Puncture Headache; Cerebrospinal Fluid Leaks
MeSH terms: Post-Dural Puncture Headache; Cerebrospinal Fluid Leak; Headache; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the use of intrathecal morphine administration
      following an unintentional dural puncture, to decrease the incidence of post dural puncture
      headaches (PDPH) in obstetric patients.
    

Detailed description: 
      Unintentional dural puncture is a known risk of neuraxial techniques, occurring in roughly 1%
      of all epidural catheter placements. The incidence of post dural puncture headaches(PDPH)
      after unintentional dural puncture (UDP) is 50-80%. A PDPH is defined as a headache that
      occurs following a dural puncture, worsens within 15 minutes after sitting or standing and
      improves within 15 minutes after lying, with at least one of the following: neck stiffness,
      tinnitus, hypacusia, photophobia, or nausea. The headache develops within 5 days after dural
      puncture and resolves either spontaneously within 1 week or within 48 hours after effective
      treatment of the spinal fluid leak.

      The rates of PDPH following unintentional dural puncture with placement of an intrathecal
      catheter will be compared in two groups: intrathecal morphine (treatment) versus intrathecal
      saline (control) administered 1-2 hours after delivery, followed by immediate catheter
      removal. Patients randomized to the treatment group (morphine) will receive preservative-free
      morphine 0.3 mL (150 mcg) intrathecally. Those randomized to the control group will receive
      normal saline 0.3 mL intrathecally. After administration of intrathecal morphine, all
      patients will have their respirations monitored every hour for a period of 12 hours and then
      every two hours for a period of 12 hours. On postpartum days 1-5, all patients will be
      visited daily while inpatient and/or contacted by phone after discharge from the hospital.

      PDPH can lead to significant morbidity and negatively impact patient satisfaction with
      postpartum recovery. Along with headache, patients may develop cranial nerve palsy during the
      postpartum period leading to permanent disability. In addition, new mothers are unable to
      bond with their babies due to headache and associated symptoms of nausea, vomiting and
      limited mobility secondary to pain. Therefore, an effective intervention to decrease the risk
      of PDPH after UDP would be useful.
    

Intervention name(s): Morphine; Saline
Intervention type(s): Drug; Drug
Intervention description(s): The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.; The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.
Other intervention name(s): Duramorph; Normal Saline
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Postdural puncture headache; Intrathecal morphine; Intrathecal catheter; Headache; Labor and delivery; Unintentional dural puncture