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The Influence of Needle Diameter on Post Dural Puncture Headache

This study is currently recruiting participants.
Verified September 2017 by Central Norway Regional Health Authority
Sponsor:
ClinicalTrials.gov Identifier:
NCT02827058
First Posted: July 11, 2016
Last Update Posted: September 25, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Sykehuset Ostfold
Information provided by (Responsible Party):
Central Norway Regional Health Authority
  Purpose
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 Intervention
Post-Dural Puncture Headache Device: G25 pencil point needle Device: G27 pencil point needle

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Central Norway Regional Health Authority:

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

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

Estimated Enrollment: 900
Actual Study Start Date: March 2016
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
  Contacts and Locations
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


Contacts
Contact: Nina Vibeche Skei ninavibeche.skei@helse-nordtrondelag.no
Contact: Jan Sverre Vamnes, md

Locations
Norway
Recruiting
Fredrikstad, Norway
Østfold Hospital Recruiting
Fredrikstad, Norway
Contact: Jan Sverre Vamnes, md         
Levanger Hospital Recruiting
Levanger, Norway
Contact: Nina Vibeche Skei       ninavibeche.skei@helse-nordtrondelag.no   
Sponsors and Collaborators
Central Norway Regional Health Authority
Sykehuset Ostfold
Investigators
Study Director: Jan Sverre Vamnes, md Østvold Hospital
  More Information

Responsible Party: Central Norway Regional Health Authority
ClinicalTrials.gov Identifier: NCT02827058     History of Changes
Other Study ID Numbers: 2016/140
First Submitted: July 6, 2016
First Posted: July 11, 2016
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
Headache
Post-Dural Puncture Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases