The Influence of Needle Diameter on Post Dural Puncture Headache

April 22, 2020 updated by: Helse Nord-Trøndelag HF

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Fredrikstad, Norway
      • Fredrikstad, Norway
        • Østfold Hospital
      • Levanger, Norway
        • Levanger Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of attempts until successful injection
Time Frame: 0 (injection time before delivery)
0 (injection time before delivery)

Secondary Outcome Measures

Outcome Measure
Time Frame
incidence of post dural puncture headache
Time Frame: 48 hrs
48 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helse Nord-Trøndelag HF

Collaborators

Sykehuset Ostfold

Investigators

  • Study Director: Jan Sverre Vamnes, md, Østvold Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

July 6, 2016

First Submitted That Met QC Criteria

July 6, 2016

First Posted (Estimate)

July 11, 2016

Study Record Updates

Last Update Posted (Actual)

April 24, 2020

Last Update Submitted That Met QC Criteria

April 22, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/140

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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