N/A
N=63
Incidence of Headache Following an Unintentional Dural Puncture
Postdural Puncture Headache · Post-Lumbar Puncture Headache · Cerebrospinal Fluid Leaks
Bottom Line
View on ClinicalTrials.gov: NCT01977898 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Participants Who Report Post Dural Puncture Headaches — 21; 27 Participants — p=.877
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Morphine (Drug); Saline (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Northwestern University
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants Who Report Post Dural Puncture Headaches |
21; 27 | .877 |
| SECONDARY Severity of Post Dural Puncture Headache |
7; 7.5 | .499 |
| SECONDARY Treatment Method for Headache |
11; 10; 9; 16; 1; 1 | .463 |
| SECONDARY Number of Participants With Cranial Nerve Symptoms |
13; 24; 1; 0; 7; 3 | .0463 sig |
| SECONDARY Repeat Epidural Blood Patch |
1; 1 | .525 |
| SECONDARY Presenting Day of Headache |
9; 11; 8; 8; 1; 4 | 0.691 |
| SECONDARY Number of Participants With Duration in Days of Headache After Unintentional Dural Puncture. |
4; 8; 5; 9; 7; 4 | 0.610 |
| SECONDARY Greatest Level of Headache Pain Experienced With the Unintentional Dural Puncture |
7; 7.5 | .499 |
| SECONDARY Intrathecal Catheter Dwell Time |
418; 427 | .06 |
| SECONDARY Intrathecal Infusion Volume |
12.9; 16.2 | .31 |
| SECONDARY Mode of Delivery |
24; 29; 3; 5 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01977898). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.