NCT02473276

Brief Summary

Neuraxial analgesia (most commonly continuous epidural or combined spinal epidural) is the most effective modality available for pain relief during labor. Accidental dural puncture (ADP) with a large bore epidural needle and the resulting post-dural puncture headache (PDPH) is one of the most significant sources of anesthesia-related morbidity in parturients. Epidural blood patch (EBP) is the gold standard for treatment of PDPH, and although almost always effective, can result in another ADP, as well as low back pain and lower extremity pain. For this reason, effective measures to prevent PDPH when ADP occurs would be highly valuable. One small study in which 50 women were randomly allocated to receive 2 epidural injections of morphine or saline, demonstrated a beneficial effect of epidural morphine in decreasing the incidence of PDPH. This study aims to determine the efficacy of 2 doses of neuraxial (either epidural (EPID) or intrathecal) preservative-free morphine (PFM) to prevent headache after ADP in parturients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2015

Longer than P75 for phase_4

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 16, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

February 5, 2025

Completed
Last Updated

February 5, 2025

Status Verified

January 1, 2025

Enrollment Period

4.3 years

First QC Date

June 3, 2015

Results QC Date

January 14, 2025

Last Update Submit

January 14, 2025

Conditions

Postdural Puncture Headache

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Postdural Puncture Headache

    The primary outcome will be the incidence of postdural puncture headache at 48 hours after accidental dural puncture. This will be determined by a face to face questionnaire and the severity of headache will be rated according to a verbal rating scale (0 -10).

    48 hours after accidental dural puncture

Secondary Outcomes (1)

  • Number of Participants in Need for Epidural Blood Patch

    48 hours after accidental dural puncture

Study Arms (4)

EPID PFM

ACTIVE COMPARATOR

The group "EPID PFM" will receive 3 mg (6 ml) of preservative-free morphine, followed by 3 ml of sterile normal saline, to be administered through the epidural catheter.Sixteen to 24 hours after receiving the first study drug, the patient will then receive the identical study drug (for a total of two doses).

Drug: MorphineDrug: Sterile normal saline

EPID SAL

SHAM COMPARATOR

The placebo group, "EPID NS", will receive 6 ml of sterile normal saline via the epidural catheter followed by another 3 ml NS. Sixteen to 24 hours after receiving the first study drug,the patient will then receive the identical study drug (for a total of two doses).

Drug: Sterile normal saline

IT PFM

ACTIVE COMPARATOR

The group, "IT PFM" will receive 200 micrograms (mcg) (0.4 ml) of preservative-free morphine via the intrathecal catheter, followed by a flush of the catheter with 2 ml of sterile saline.Sixteen to 24 hours after receiving the first study drug, the patient will then receive the identical study drug (for a total of two doses).

Drug: MorphineDrug: Sterile normal saline

IT SAL

SHAM COMPARATOR

The placebo group IT SAL will receive 0.4 ml and then 2 ml of sterile normal saline through the intrathecal catheter.Sixteen to 24 hours after receiving the first study drug, the patient will then receive the identical study drug (for a total of two doses).

Drug: Sterile normal saline

Interventions

MorphineDRUG

preservative free morphine given either via an epidural or intrathecal catheter

Also known as: Duramorph
EPID PFMIT PFM
Sterile normal salineDRUG

sterile normal saline, given either via an epidural or intrathecal catheter

Also known as: Saline
EPID PFMEPID SALIT PFMIT SAL

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects will be ASA I and II women aged 18 years and older, who are known to have had accidental dural puncture with an epidural needle during placement of neuraxial labor analgesia, and have either an intrathecal catheter or epidural catheter in place.

You may not qualify if:

  • Past history of headache syndromes- such as migraine and cluster headaches
  • History of chronic pain syndromes
  • Chronic opioid use
  • Illicit drug use - e.g. marijuana, heroin
  • Allergy to morphine
  • Intrapartum or postpartum fever ≥ 38 ° C
  • Coagulopathy
  • Accidental removal of the epidural or intrathecal catheter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Rutgers Health University Hospital

Newark, New Jersey, 07103, United States

Location

Weill Cornell Medical Center

New York, New York, 10021, United States

Location

New York Presbyterian Hospital

New York, New York, 10032, United States

Location

Montefiore Hospital

New York, New York, 10467, United States

Location

Related Publications (2)

  • Al-metwalli RR. Epidural morphine injections for prevention of post dural puncture headache. Anaesthesia. 2008 Aug;63(8):847-50. doi: 10.1111/j.1365-2044.2008.05494.x. Epub 2008 Jun 10.

    PMID: 18547293BACKGROUND

  • Scavone BM, Wong CA, Sullivan JT, Yaghmour E, Sherwani SS, McCarthy RJ. Efficacy of a prophylactic epidural blood patch in preventing post dural puncture headache in parturients after inadvertent dural puncture. Anesthesiology. 2004 Dec;101(6):1422-7. doi: 10.1097/00000542-200412000-00024.

    PMID: 15564951BACKGROUND

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

MorphineSodium Chloride

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Results Point of Contact

Title
Richard Smiley
Organization
Columbia University
rms7@cumc.columbia.edu
212 305 5006

Study Officials

  • Richard Smiley, MD, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

June 3, 2015

First Posted

June 16, 2015

Study Start

September 1, 2015

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

February 5, 2025

Results First Posted

February 5, 2025

Record last verified: 2025-01

Locations

US(4)