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Completed

NCT Number: NCT01977898

Incidence of Headache Following an Unintentional Dural Puncture

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Morphine

Drug

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 names: Duramorph

Saline

Drug

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 names: Normal Saline

Primary outcomes

  1. Participants Who Report Post Dural Puncture Headaches

    Time frame: 5 days

    Participants who report post dural puncture headaches from delivery to postpartum day 5

Secondary outcomes

  1. Severity of Post Dural Puncture Headache

    Time frame: Time of unintentional dural puncture to postpartum day 5

    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.

  2. Treatment Method for Headache

    Time frame: Unintentional dural puncture - Postpartum day 5

    Treatment method completed for unintentional dural puncture headache.

  3. Number of Participants With Cranial Nerve Symptoms

    Time frame: 5 days

    The number of participants who experience cranial nerve symptoms up to 5 days after the unintentional dural puncture.

  4. Repeat Epidural Blood Patch

    Time frame: After first epidural blood patch to 5 days after delivery

    Repeated epidural blood patch for headache pain after unintentional dural puncture.

  5. Presenting Day of Headache

    Time frame: Dural puncture to 5 days after delivery

    Presenting day of headache after unintentional dural puncture

  6. Number of Participants With Duration in Days of Headache After Unintentional Dural Puncture.

    Time frame: 5 days

    The duration in days of headaches the participants experience after an unintentional dural puncture

  7. Greatest Level of Headache Pain Experienced With the Unintentional Dural Puncture

    Time frame: 5 days

    Greatest reported headache pain associated with unintentional dural puncture reported on a scale of 0= no pain to 10= worst pain imaginable.

  8. Intrathecal Catheter Dwell Time

    Time frame: Insertion time to removal in minutes

    Intrathecal catheter dwell time(time from insertion to time of removal in minutes).

  9. Intrathecal Infusion Volume

    Time frame: Time of insertion of catheter to time catheter removed

    Intrathecal infusion volume in milliliters

  10. Mode of Delivery

    Time frame: up to 10 hours after intrathecal catheter placed

    Mode of delivery of the baby (vaginal delivery or instrumented vaginal delivery)

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Incidence of Post-Dural Puncture Headache Following Unintentional Dural Puncture: A Randomized Trial of Intrathecal Morphine Versus Saline

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Nov 7, 2013
Registry last updated
Nov 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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