Incidence of Headache Following an Unintentional Dural Puncture

Study Overview
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Brief Summary
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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
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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.

Official Title
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Incidence of Post-Dural Puncture Headache Following Unintentional Dural Puncture: A Randomized Trial of Intrathecal Morphine Versus Saline

Conditions
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Postdural Puncture Headache, Post-Lumbar Puncture Headache, Cerebrospinal Fluid Leaks

Intervention / Treatment
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* Drug: Morphine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Morphine<br>Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally. | Drug: Morphine<br>* 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.<br>* Other names: Duramorph;|
| Placebo Comparator: Saline<br>Patients randomized to the control group will receive normal saline 0.3 mL intrathecally. | Drug: Saline<br>* 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.<br>* Other names: Normal Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants Who Report Post Dural Puncture Headaches | Participants who report post dural puncture headaches from delivery to postpartum day 5 | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Time of unintentional dural puncture to postpartum day 5 | 
| Treatment Method for Headache | Treatment method completed for unintentional dural puncture headache. | Unintentional dural puncture - Postpartum day 5 | 
| 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. | 5 days | 
| Repeat Epidural Blood Patch | Repeated epidural blood patch for headache pain after unintentional dural puncture. | After first epidural blood patch to 5 days after delivery | 
| Presenting Day of Headache | Presenting day of headache after unintentional dural puncture | Dural puncture to 5 days after delivery | 
| 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 | 5 days | 
| 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. | 5 days | 
| Intrathecal Catheter Dwell Time | Intrathecal catheter dwell time(time from insertion to time of removal in minutes). | Insertion time to removal in minutes | 
| Intrathecal Infusion Volume | Intrathecal infusion volume in milliliters | Time of insertion of catheter to time catheter removed | 
| Mode of Delivery | Mode of delivery of the baby (vaginal delivery or instrumented vaginal delivery) | up to 10 hours after intrathecal catheter placed | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postdural puncture headache, Intrathecal morphine, Intrathecal catheter, Headache, Labor and delivery, Unintentional dural puncture