Incidence of Headache Following an Unintentional Dural Puncture
Primary Purpose
Postdural Puncture Headache, Post-Lumbar Puncture Headache, Cerebrospinal Fluid Leaks
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Morphine
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Postdural Puncture Headache focused on measuring Postdural puncture headache, Intrathecal morphine, Intrathecal catheter, Headache, Labor and delivery, Unintentional dural puncture
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
Sites / Locations
- Northwestern Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Morphine
Saline
Arm Description
Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally.
Patients randomized to the control group will receive normal saline 0.3 mL intrathecally.
Outcomes
Primary Outcome Measures
Participants Who Report Post Dural Puncture Headaches
Participants who report post dural puncture headaches from delivery to postpartum day 5
Secondary Outcome Measures
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.
Treatment Method for Headache
Treatment method completed for unintentional dural puncture headache.
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.
Repeat Epidural Blood Patch
Repeated epidural blood patch for headache pain after unintentional dural puncture.
Presenting Day of Headache
Presenting day of headache after unintentional dural puncture
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
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.
Intrathecal Catheter Dwell Time
Intrathecal catheter dwell time(time from insertion to time of removal in minutes).
Intrathecal Infusion Volume
Intrathecal infusion volume in milliliters
Mode of Delivery
Mode of delivery of the baby (vaginal delivery or instrumented vaginal delivery)
Full Information
NCT ID
NCT01977898
First Posted
October 31, 2013
Last Updated
November 15, 2021
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT01977898
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
March 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postdural Puncture Headache, Post-Lumbar Puncture Headache, Cerebrospinal Fluid Leaks
Keywords
Postdural puncture headache, Intrathecal morphine, Intrathecal catheter, Headache, Labor and delivery, Unintentional dural puncture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Morphine
Arm Type
Experimental
Arm Description
Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Patients randomized to the control group will receive normal saline 0.3 mL intrathecally.
Intervention Type
Drug
Intervention Name(s)
Morphine
Other Intervention Name(s)
Duramorph
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Normal Saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participants Who Report Post Dural Puncture Headaches
Description
Participants who report post dural puncture headaches from delivery to postpartum day 5
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Severity of Post Dural Puncture Headache
Description
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 Frame
Time of unintentional dural puncture to postpartum day 5
Title
Treatment Method for Headache
Description
Treatment method completed for unintentional dural puncture headache.
Time Frame
Unintentional dural puncture - Postpartum day 5
Title
Number of Participants With Cranial Nerve Symptoms
Description
The number of participants who experience cranial nerve symptoms up to 5 days after the unintentional dural puncture.
Time Frame
5 days
Title
Repeat Epidural Blood Patch
Description
Repeated epidural blood patch for headache pain after unintentional dural puncture.
Time Frame
After first epidural blood patch to 5 days after delivery
Title
Presenting Day of Headache
Description
Presenting day of headache after unintentional dural puncture
Time Frame
Dural puncture to 5 days after delivery
Title
Number of Participants With Duration in Days of Headache After Unintentional Dural Puncture.
Description
The duration in days of headaches the participants experience after an unintentional dural puncture
Time Frame
5 days
Title
Greatest Level of Headache Pain Experienced With the Unintentional Dural Puncture
Description
Greatest reported headache pain associated with unintentional dural puncture reported on a scale of 0= no pain to 10= worst pain imaginable.
Time Frame
5 days
Title
Intrathecal Catheter Dwell Time
Description
Intrathecal catheter dwell time(time from insertion to time of removal in minutes).
Time Frame
Insertion time to removal in minutes
Title
Intrathecal Infusion Volume
Description
Intrathecal infusion volume in milliliters
Time Frame
Time of insertion of catheter to time catheter removed
Title
Mode of Delivery
Description
Mode of delivery of the baby (vaginal delivery or instrumented vaginal delivery)
Time Frame
up to 10 hours after intrathecal catheter placed
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feyce Peralta, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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Citation
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Incidence of Headache Following an Unintentional Dural Puncture
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