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The Influence of Needle Diameter on Post Dural Puncture Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02827058
Recruitment Status : Terminated (due to difficulties recruiting patients and therefore too slow progress)
First Posted : July 11, 2016
Last Update Posted : April 24, 2020
Sponsor:
Collaborator:
Sykehuset Ostfold
Information provided by (Responsible Party):
Central Norway Regional Health Authority

Brief Summary:
The purpose of this study is to determine whether injection needle pen point type 'PP Gauge 25' should be recommended as a primary choice of needle (in stead of 'PP Gauge 27') for healthy pregnant women who at delivery (vaginal or cesarean section) get spinal anesthesia.

Condition or disease Intervention/treatment Phase
Post-Dural Puncture Headache Device: G25 pencil point needle Device: G27 pencil point needle Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Influence of Needle Diameter on Needle Failures and Post Dural Puncture Headache in Relation to Cesarean Section and Vaginal Delivery; a Prospective, Randomised Trial
Actual Study Start Date : March 2016
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: G25 pencil point needle
healthy pregnant women who at (vaginal or cesarean section) delivery get spinal anesthesia administered with use of a 25 gauge pencil point needle
Device: G25 pencil point needle
Active Comparator: G27 pencil point needle
healthy pregnant women who at (vaginal or cesarean section) delivery get spinal anesthesia administered with use of a 27 gauge pencil point needle
Device: G27 pencil point needle



Primary Outcome Measures :
  1. number of attempts until successful injection [ Time Frame: 0 (injection time before delivery) ]

Secondary Outcome Measures :
  1. incidence of post dural puncture headache [ Time Frame: 48 hrs ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • healthy
  • pregnant
  • spinal anesthesia at delivery (vaginal delivery or cesarean section emergency grade 2-4)
  • informed consent

Exclusion Criteria:

  • chronic headache
  • (attempt to) epidural anesthesia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02827058


Locations
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Norway
Fredrikstad, Norway
Østfold Hospital
Fredrikstad, Norway
Levanger Hospital
Levanger, Norway
Sponsors and Collaborators
Central Norway Regional Health Authority
Sykehuset Ostfold
Investigators
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Study Director: Jan Sverre Vamnes, md Østvold Hospital
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Responsible Party: Central Norway Regional Health Authority
ClinicalTrials.gov Identifier: NCT02827058    
Other Study ID Numbers: 2016/140
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Central Norway Regional Health Authority:
Delivery, obstetric
Analgesia, Epidural
Injections, Epidural
Needles
Cesarean Section
Additional relevant MeSH terms:
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Post-Dural Puncture Headache
Headache
Pain
Neurologic Manifestations
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases