Incidence of Headache Following an Unintentional Dural Puncture

checkorphan
Learn more about:
Cerebrospinal fluid leak
Related Clinical Trial
The Primary Objective of the Study is to Retrospectively Evaluate the Safety and Efficacy of the Suturable DuraGen™ Evaluation of Outcomes Related to Cerebrospinal Fluid Drain Placement The Efficacy and Safety of a Latest Dural Substitute Sphenopalatine Ganglion Nerve Block for Postdural Puncture Headache in Obstetrics Incidence of Headache Following an Unintentional Dural Puncture Cerebrospinal Fluid Rhinorrhea After Functional Endoscopic Sinus Surgery TASALL – TachoSil® Against Liquor Leak Performance and Safety of I-020805 in Prevention of Cerebrospinal Fluid (CSF) Leakage Following Elective Craniotomy Mobilisation Algorithm After Incidental Durotomy Post-market Assessment of Biodesign Dural Repair Grafts Acetazolamide to Prevent Post Operative CSF Leak Acetazolamide for the Prevention of Post Operative CSF Leak A Randomized Trial of CT Fluoroscopy-guided Targeted Autologous Blood and Fibrin Glue Patching for Treatment Efficacy and Safety of FS VH S/D 500 S-apr (Tisseel) as an Adjunct to Sutured Dural Repair in Cranial Surgery The EVICEL® Neurosurgery Phase III Study Perioperative CSF Leak Management – an Opinion Study Evaluate the Safety and Performance of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery

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