Incidence of Headache Following an Unintentional Dural Puncture

Not Applicable

Completed

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

Interventions: Drug: Morphine
Drug: Saline

Registration Number: NCT01977898

Lead Sponsor: Northwestern University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 68

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Morphine	Morphine	Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally.
Saline	Saline	Patients randomized to the control group will receive normal saline 0.3 mL intrathecally.

Primary Outcome Measures

Name	Time	Method
Participants Who Report Post Dural Puncture Headaches	5 days	Participants who report post dural puncture headaches from delivery to postpartum day 5

Secondary Outcome Measures

Name	Time	Method
Severity of Post Dural Puncture Headache	Time of unintentional dural puncture to postpartum day 5	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.
Treatment Method for Headache	Unintentional dural puncture - Postpartum day 5	Treatment method completed for unintentional dural puncture headache.
Presenting Day of Headache	Dural puncture to 5 days after delivery	Presenting day of headache after unintentional dural puncture
Number of Participants With Duration in Days of Headache After Unintentional Dural Puncture.	5 days	The duration in days of headaches the participants experience after an unintentional dural puncture
Greatest Level of Headache Pain Experienced With the Unintentional Dural Puncture	5 days	Greatest reported headache pain associated with unintentional dural puncture reported on a scale of 0= no pain to 10= worst pain imaginable.
Intrathecal Catheter Dwell Time	Insertion time to removal in minutes	Intrathecal catheter dwell time(time from insertion to time of removal in minutes).
Intrathecal Infusion Volume	Time of insertion of catheter to time catheter removed	Intrathecal infusion volume in milliliters
Mode of Delivery	up to 10 hours after intrathecal catheter placed	Mode of delivery of the baby (vaginal delivery or instrumented vaginal delivery)
Number of Participants With Cranial Nerve Symptoms	5 days	The number of participants who experience cranial nerve symptoms up to 5 days after the unintentional dural puncture.
Repeat Epidural Blood Patch	After first epidural blood patch to 5 days after delivery	Repeated epidural blood patch for headache pain after unintentional dural puncture.