Incidence of Headache Following an Unintentional Dural Puncture

Northwestern University

Status: Completed

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

Treatments: Drug: Saline; Drug: Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT01977898

STU00043549

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 2 patient groups, including a placebo group

Morphine

Experimental group

Description:

Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally.

Treatment:

Drug: Morphine

Saline

Placebo Comparator group

Description:

Patients randomized to the control group will receive normal saline 0.3 mL intrathecally.

Treatment:

Drug: Saline