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 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.
Study Type
Interventional
Primary Outcome
Participants Who Report Post Dural Puncture Headaches
Secondary Outcome
Severity of Post Dural Puncture Headache
Condition
Postdural Puncture Headache
Intervention
Morphine
Study Arms / Comparison Groups
Morphine
Description: Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
68
Start Date
November 2011
Completion Date
March 1, 2019
Primary Completion Date
March 1, 2019
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
Gender
Female
Ages
18 Years - 45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Feyce Peralta, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01977898
Organization ID
STU00043549
Responsible Party
Principal Investigator
Study Sponsor
Northwestern University
Study Sponsor
Feyce Peralta, MD, Principal Investigator, Northwestern University
Verification Date
November 2021