The Influence of Needle Diameter on Post Dural Puncture Headache

NCT ID: NCT02827058

Last Updated: 2020-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Post-Dural Puncture Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

G25 pencil point needle

Intervention Type DEVICE

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

Group Type ACTIVE_COMPARATOR

G27 pencil point needle

Intervention Type DEVICE

Interventions

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G25 pencil point needle

Intervention Type DEVICE

G27 pencil point needle

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sykehuset Ostfold

OTHER

Sponsor Role collaborator

Helse Nord-Trøndelag HF

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan Sverre Vamnes, md

Role: STUDY_DIRECTOR

Østvold Hospital

Locations

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Østfold Hospital

Fredrikstad, , Norway

Site Status

Fredrikstad, , Norway

Site Status

Levanger Hospital

Levanger, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2016/140

Identifier Type: -

Identifier Source: org_study_id

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