This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

The Influence of Needle Diameter on Post Dural Puncture Headache

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Central Norway Regional Health Authority
Sponsor:
Collaborator:
Sykehuset Ostfold
Information provided by (Responsible Party):
Central Norway Regional Health Authority
ClinicalTrials.gov Identifier:
NCT02827058
First received: July 6, 2016
Last updated: August 15, 2017
Last verified: August 2017
  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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: July 6, 2016
Last Updated: August 15, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

ClinicalTrials.gov processed this record on September 19, 2017