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Postdural Puncture Headache | Incidence of Headache Following an Unintentional Dural Puncture

Postdural Puncture Headache research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Postdural Puncture Headache

Post-Lumbar Puncture Headache

Cerebrospinal Fluid Leaks

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:MorphineThe 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.

Drug:SalineThe 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

Study Status

Recruiting

Start Date: November 2011

Completed Date: June 2020

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Incidence of post dural puncture headaches

Secondary Outcome: Severity of headache

Study sponsors, principal investigator, and references

Principal Investigator: Feyce Peralta, MD

Lead Sponsor: Northwestern University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01977898

Apfel CC, Saxena A, Cakmakkaya OS, Gaiser R, George E, Radke O. Prevention of postdural puncture headache after accidental dural puncture: a quantitative systematic review. Br J Anaesth. 2010 Sep;105(3):255-63. doi: 10.1093/bja/aeq191. Epub 2010 Aug 3. Review.

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