Are you healthy and looking to help advance medical science?
You may be eligible to participate in a postdural puncture headache clinical study, and could be compensated for your time.
Are you healthy and looking to help advance medical science? You may be eligible to participate in a postdural puncture headache clinical study, and could be compensated for your time.
What is a clinical trial? Is participating in a clinical trial right for you? Learn more
Postdural Puncture Headache Clinical Trial in Chicago IL
Are you healthy and looking to help advance medical science?
You may be eligible to participate in a postdural puncture headache clinical study, and could be compensated for your time.
Are you healthy and looking to help advance medical science? You may be eligible to participate in a postdural puncture headache clinical study, and could be compensated for your time.
Completed
Female
18 - 45
Years old
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.
Details for the study
Brief Title
Incidence of Headache Following an Unintentional Dural Puncture
Official Title
Incidence of Post-Dural Puncture Headache Following Unintentional Dural Puncture: A Randomized Trial of Intrathecal Morphine Versus Saline
Brief Summary
The purpose of this study is to evaluate the use of intrathecal morphine administration <br /> following an unintentional dural puncture, to decrease the incidence of post dural puncture <br /> 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.
Treatments and/or Procedures
Saline
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.
Morphine
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.
Outcome Measures
Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.
Primary
Participants Who Report Post Dural Puncture Headaches
Participants who report post dural puncture headaches from delivery to postpartum day 5
Secondary
Greatest Level of Headache Pain Experienced With the Unintentional Dural Puncture
Greatest reported headache pain associated with unintentional dural puncture reported on a scale of 0= no pain to 10= worst pain imaginable.
Secondary
Mode of Delivery
Mode of delivery of the baby (vaginal delivery or instrumented vaginal delivery)
Secondary
Intrathecal Infusion Volume
Intrathecal infusion volume in milliliters
Secondary
Intrathecal Catheter Dwell Time
Intrathecal catheter dwell time(time from insertion to time of removal in minutes).
Secondary
Treatment Method for Headache
Treatment method completed for unintentional dural puncture headache.
Secondary
Number of Participants With Duration in Days of Headache After Unintentional Dural Puncture.
The duration in days of headaches the participants experience after an unintentional dural puncture
Secondary
Presenting Day of Headache
Presenting day of headache after unintentional dural puncture
Secondary
Repeat Epidural Blood Patch
Repeated epidural blood patch for headache pain after unintentional dural puncture.
Secondary
Number of Participants With Cranial Nerve Symptoms
The number of participants who experience cranial nerve symptoms up to 5 days after the unintentional dural puncture.
Secondary
Severity of Post Dural Puncture Headache
Severity of post dural puncture headache on a numerical rating scale 0= no pain and 10= worst pain imaginable from the time of delivery to postpartum day 5.
Study Criteria
Inclusion Criteria:
- Postpartum patients following vaginal delivery
- Unintentional dural puncture
- Functioning intrathecal catheter
- Patients must be 18 years of age or older
- English speaking.
Exclusion Criteria:
- History of previous PDPH
- Body mass index BMI > 40 kg/m2
- History of obstructive sleep apnea (OSA)
- Morphine allergy
- Patients who receive Cesarean delivery