Incidence of Headache Following an Unintentional Dural Puncture

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
Cynthia Wong, Northwestern University
ClinicalTrials.gov Identifier:
NCT01977898
First received: October 31, 2013
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Postdural Puncture Headache
Post-Lumbar Puncture Headache
Cerebrospinal Fluid Leaks
Drug: Morphine
Drug: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Incidence of Post-Dural Puncture Headache Following Unintentional Dural Puncture: A Randomized Trial of Intrathecal Morphine Versus Saline

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Incidence of post dural puncture headaches [ Time Frame: Delivery - postpartum day 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Severity of headache [ Time Frame: Delivery - Postpartum day 5 ] [ Designated as safety issue: No ]
  • Need for Epidural Blood Patch [ Time Frame: Delivery - Postpartum day 5 ] [ Designated as safety issue: No ]

Estimated Enrollment: 170
Study Start Date: November 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Morphine
Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally.
Drug: Morphine
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.
Other Name: Duramorph
Placebo Comparator: Saline
Patients randomized to the control group will receive normal saline 0.3 mL intrathecally.
Drug: Saline
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.
Other Name: Normal Saline

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01977898

Contacts
Contact: Cynthia Wong, MD 312-472-3585 c-wong2@northwestern.edu
Contact: Robert J McCarthy, PharmD 312-926-9015 r-mccarthy@northwestern.edu

Locations
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Robert J McCarthy, PharmD    312-926-9015    r-mccarthy@northwestern.edu   
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Cynthia Wong, MD Northwestern University
  More Information

Publications:

Responsible Party: Cynthia Wong, Professor of Anesthesiology, Northwestern University
ClinicalTrials.gov Identifier: NCT01977898     History of Changes
Other Study ID Numbers: STU00043549
Study First Received: October 31, 2013
Last Updated: April 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Postdural puncture headache
Intrathecal morphine
Intrathecal catheter
Headache
Labor and delivery
Unintentional dural puncture

Additional relevant MeSH terms:
Headache
Post-Dural Puncture Headache
Headache Disorders, Secondary
Headache Disorders
Cerebrospinal Fluid Rhinorrhea
Intracranial Hypotension
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on July 26, 2014