Clinical trial NCT01977898: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postdural Puncture Headache
Post-Lumbar Puncture Headache
Cerebrospinal Fluid Leaks
Keywords: Postdural puncture headache
Intrathecal morphine
Intrathecal catheter
Headache
Labor and delivery
Unintentional dural puncture
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2013-11-07
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Participants Who Report Post Dural Puncture Headaches
timeFrame: 5 days
Secondary outcomes:
measure: Severity of Post Dural Puncture Headache
timeFrame: Time of unintentional dural puncture to postpartum day 5
measure: Treatment Method for Headache
timeFrame: Unintentional dural puncture - Postpartum day 5
measure: Number of Participants With Cranial Nerve Symptoms
timeFrame: 5 days
measure: Repeat Epidural Blood Patch
timeFrame: After first epidural blood patch to 5 days after delivery
measure: Presenting Day of Headache
timeFrame: Dural puncture to 5 days after delivery
measure: Number of Participants With Duration in Days of Headache After Unintentional Dural Puncture.
timeFrame: 5 days
measure: Greatest Level of Headache Pain Experienced With the Unintentional Dural Puncture
timeFrame: 5 days
measure: Intrathecal Catheter Dwell Time
timeFrame: Insertion time to removal in minutes
measure: Intrathecal Infusion Volume
timeFrame: Time of insertion of catheter to time catheter removed
measure: Mode of Delivery
timeFrame: up to 10 hours after intrathecal catheter placed
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Feyce Peralta, MD
role: PRINCIPAL_INVESTIGATOR
References:
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